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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK123813 | U.S. NIH Grant/Contract | View source | |
| U01DK123786 | U.S. NIH Grant/Contract | View source | |
| U01DK123787 | U.S. NIH Grant/Contract | View source | |
| U01DK123812 | U.S. NIH Grant/Contract | View source | |
| U01DK123814 | U.S. NIH Grant/Contract | View source | |
| U01DK123816 | U.S. NIH Grant/Contract | View source | |
| U01DK123817 | U.S. NIH Grant/Contract | View source | |
| U01DK123818 | U.S. NIH Grant/Contract | View source | |
| U01DK123821 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hennepin Health Care | UNKNOWN |
| New York University | OTHER |
| Massachusetts General Hospital | OTHER |
| University of Illinois at Chicago |
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HOPE is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. The hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Skills Training | Active Comparator | The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish. |
|
| Usual Care | Other | Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Skills Training (PCST) | Behavioral | The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse. | The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse. | Weeks 12, 24, and 36 |
| Pain Catastrophizing |
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Inclusion Criteria:
Exclusion Criteria:
Subgroup with Current or Recent Opioid Use During eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. The trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. The number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. If the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.
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| Name | Affiliation | Role |
|---|---|---|
| Laura Dember, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven VA Healthcare System | West Haven | Connecticut | 06516 | United States | ||
| University of Illinois at Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39786400 | Derived | Dember LM, Hsu JY, Mehrotra R, Cavanaugh KL, Kalim S, Charytan DM, Fischer MJ, Jhamb M, Johansen KL, Becker WC, Pellegrino B, Eneanya ND, Schrauben SJ, Pun PH, Unruh ML, Morasco BJ, Mehta M, Miyawaki N, Penfield J, Bernardo L, Brintz CE, Cheatle MD, Doorenbos AZ, Heapy AA, Keefe FJ, Krebs EE, Kuzla N, Nigwekar SU, Schmidt RJ, Steel JL, Wetmore JB, White DM, Kimmel PL, Cukor D; HOPE Consortium. Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140. | |
| 39627496 |
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De-identified participant-level data will be transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK) Central Repository after the trial has been completed.
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The original enrollment target was 640 participants. Permission to over-enroll was granted by the single IRB of record due to the nature of 16 recruitment sites enrolling simultaneously. The study teams did not want to have to exclude participants who had been consented and were in the screening process when the original target of 640 was reached. Therefore, 3 extra participants were enrolled as they had already been consented when the 640th participant was randomized.
643 participants were randomized across 16 recruitment sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pain Coping Skills Training (PCST) | PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2023 |
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| OTHER |
| University of Pittsburgh | OTHER |
| University of Washington | OTHER |
| University of New Mexico | OTHER |
| Rogosin Institute | UNKNOWN |
| Vanderbilt University Medical Center | OTHER |
| West Virginia University | OTHER |
| Yale University | OTHER |
| Durham VA Health Care System | FED |
| VA Portland Healthcare System | UNKNOWN |
| West Haven VA Medical Center | UNKNOWN |
| University of Pennsylvania | OTHER |
| Dallas VA Medical Center | FED |
| VA New York Harbor Healthcare System | FED |
Sequential multiple assignment design with a randomized component followed by a non-randomized component
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| Buprenorphine | Drug | At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse.
| Weeks 12, 24, and 36 |
| Opioid Use | Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A | Weeks 12, 24, and 36 |
| Number of Falls | Number of fall events per arm. | Throughout the 36-week follow-up |
| Rate of Falls | Event rate as calculated by number of falls/patient years | Though Week 36 follow-up |
| Number of Hospitalizations | Number of hospitalizations per arm. | Through 36-week follow-up |
| Rate of Hospitalizations | Event rate as calculated by number of hospitalizations/patient years | Through Week 36 follow-up |
| Number of Deaths | The number of deaths per arms. | Through the 36-week follow-up |
| Rate of Deaths | Rate of deaths as calculated by number of events/patient years | Through Week 36 follow-up |
| Buprenorphine Acceptability | The proportion of participants who initiate buprenorphine from among those offered buprenorphine. | Through Week 36 |
| Buprenorphine Tolerability | The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance. | Through Week 36 |
| Overall Sense of Quality of Life | Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome. | Weeks 12, 24, and 36 |
| Physical Functioning | Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. | Weeks 12, 24, and 36 |
| Depression | Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome. | Weeks 12, 24, and 36 |
| Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome. | Weeks 12, 24, and 36 |
| Coping | Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome. | Weeks 12, 24, and 36 |
| Sleep Quality | Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. | Weeks 12, 24, and 36 |
| Fatigue | Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. | Weeks 12, 24, and 36 |
| Satisfaction With Treatment | Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome. | Weeks 12, 24, and 36 |
| Social Support | Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported. | Weeks 12, 24, and 36 |
| Family Intrusion | Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. | Weeks 12, 24, and 36 |
| Self-Efficacy | Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Normalized score reported. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome. | Weeks 12, 24, and 36 |
| Presence of Other Symptoms | Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome. | Weeks 12, 24, and 36 |
| Severity of Other Symptoms | Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome. | Week 12, 24, 36 |
| Discrimination | Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome. | Baseline, Week 36 |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| New York University | New York | New York | 10010 | United States |
| VA NY Harbor Healthcare System | New York | New York | 10010 | United States |
| Rogosin Institute | New York | New York | 10021 | United States |
| Durham VA Healthcare System | Durham | North Carolina | 27705 | United States |
| VA Portland Healthcare System | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Derived |
| Steel JL, Brintz CE, Heapy AA, Keefe F, Cheatle MD, Jhamb M, McNeil DW, Shallcross AJ, Kimmel PL, Dember LM, White DM, Williams J, Cukor D. Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease. J Behav Med. 2025 Apr;48(2):298-307. doi: 10.1007/s10865-024-00534-x. Epub 2024 Dec 3. |
| 38086444 | Derived | Dember LM, Hsu JY, Bernardo L, Cavanaugh KL, Charytan DM, Crowley ST, Cukor D, Doorenbos AZ, Edwards DA, Esserman D, Fischer MJ, Jhamb M, Joffe S, Johansen KL, Kalim S, Keefe FJ, Kimmel PL, Krebs EE, Kuzla N, Mehrotra R, Mishra P, Pellegrino B, Steel JL, Unruh ML, White DM, Yabes JG, Becker WC; HOPE Consortium. The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis. Contemp Clin Trials. 2024 Jan;136:107409. doi: 10.1016/j.cct.2023.107409. Epub 2023 Dec 10. |
| FG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pain Coping Skills Training | Pain Coping Skills Training (PCST): The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish. |
| BG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Interference | Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse. | Participants withdrew at various points during the trial. Some participants were not able to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions. |
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| Secondary | Pain Intensity | Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse. | Participants withdrew at various points during the study. Some participants were not able to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Pain Catastrophizing | Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse. | Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Opioid Use | Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A | Not all participants reported opioid use, as this was not an inclusion criterion but rather a subset of the study population. This outcome was assessed only for those participants reporting opioid use at the time of enrollment. | Posted | Mean | Standard Deviation | morphine milliequivalents | Weeks 12, 24, and 36 |
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| Secondary | Number of Falls | Number of fall events per arm. | Posted | Number | number of falls | Throughout the 36-week follow-up |
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| Secondary | Rate of Falls | Event rate as calculated by number of falls/patient years | Posted | Number | falls/patient year | Though Week 36 follow-up |
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| Secondary | Number of Hospitalizations | Number of hospitalizations per arm. | Posted | Number | hospitalizations | Through 36-week follow-up |
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| Secondary | Rate of Hospitalizations | Event rate as calculated by number of hospitalizations/patient years | Posted | Number | hospitalizations/patient year | Through Week 36 follow-up |
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| Secondary | Number of Deaths | The number of deaths per arms. | Posted | Number | deaths | Through the 36-week follow-up |
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| Secondary | Rate of Deaths | Rate of deaths as calculated by number of events/patient years | Posted | Number | deaths/patient year | Through Week 36 follow-up |
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| Secondary | Buprenorphine Acceptability | The proportion of participants who initiate buprenorphine from among those offered buprenorphine. | Posted | Number | proportion of participants | Through Week 36 |
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| Secondary | Buprenorphine Tolerability | The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance. | Posted | Number | proportion of participants | Through Week 36 |
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| Secondary | Overall Sense of Quality of Life | Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome. | Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Physical Functioning | Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. | Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | T-score | Weeks 12, 24, and 36 |
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| Secondary | Depression | Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome. | Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome. | Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Coping | Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome. | Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Sleep Quality | Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. | Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | t-score | Weeks 12, 24, and 36 |
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| Secondary | Fatigue | Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. | Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | t-score | Weeks 12, 24, and 36 |
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| Secondary | Satisfaction With Treatment | Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome. | Participants withdrew at various times throughout the trial, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Social Support | Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported. | Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Family Intrusion | Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. | Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | T-score | Weeks 12, 24, and 36 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Self-Efficacy | Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Normalized score reported. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome. | Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Presence of Other Symptoms | Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome. | Participants withdrew at various points during the study. Not all participants were able to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, and 36 |
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| Secondary | Severity of Other Symptoms | Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome. | Participants withdrew at various times during the trial. Not all participants were able to complete the PRO assessments. | Posted | Mean | Standard Deviation | score on a scale | Week 12, 24, 36 |
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| Secondary | Discrimination | Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome. | Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 36 |
|
Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Coping Skills Training | PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. | 35 | 319 | 169 | 319 | 102 | 319 |
| EG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. | 34 | 324 | 167 | 324 | 115 | 324 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Volume overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COVD-19 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| AV graft complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Kidney transplant | Surgical and medical procedures | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| choledocolithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Anaphylactic shock | Immune system disorders | Systematic Assessment |
| ||
| Peritoneal carcinomatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| acute mesenteric ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| acute toxic metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| altered mental status | Psychiatric disorders | Systematic Assessment |
| ||
| ambulatory dysfunction | General disorders | Systematic Assessment |
| ||
| amputation | Surgical and medical procedures | Systematic Assessment |
| ||
| angina | Cardiac disorders | Systematic Assessment |
| ||
| angioplasty | Surgical and medical procedures | Systematic Assessment |
| ||
| anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| assault | Social circumstances | Systematic Assessment |
| ||
| asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| atherosclerosis | Vascular disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| AV heart block | Cardiac disorders | Systematic Assessment |
| ||
| AV fistula complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| AV fistula placement | Surgical and medical procedures | Systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| bacteremia | Infections and infestations | Systematic Assessment |
| ||
| bed bugs | Social circumstances | Systematic Assessment |
| ||
| bladder infection | Infections and infestations | Systematic Assessment |
| ||
| blod clot | Vascular disorders | Systematic Assessment |
| ||
| blood infection | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| brain infarct | Nervous system disorders | Systematic Assessment |
| ||
| bronchial inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| c. diff | Infections and infestations | Systematic Assessment |
| ||
| CABG | Surgical and medical procedures | Systematic Assessment |
| ||
| car accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| cardiac ablation | Surgical and medical procedures | Systematic Assessment |
| ||
| cardiac catheterization | Investigations | Systematic Assessment |
| ||
| cellulitis | Infections and infestations | Systematic Assessment |
| ||
| chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| critical limb ischemia | Vascular disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| decreased cardiac function | Cardiac disorders | Systematic Assessment |
| ||
| depression | Psychiatric disorders | Systematic Assessment |
| ||
| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| dental abscess | Infections and infestations | Systematic Assessment |
| ||
| diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| diabetic necrotizing infection | Infections and infestations | Systematic Assessment |
| ||
| diabetic ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| dialysis | Surgical and medical procedures | Systematic Assessment |
| ||
| dialysis access complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| dialysis access creation | Surgical and medical procedures | Systematic Assessment |
| ||
| dialysis access infection | Infections and infestations | Systematic Assessment |
| ||
| dialysis access revision | Surgical and medical procedures | Systematic Assessment |
| ||
| dialysis access surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| duodenal avm | Vascular disorders | Systematic Assessment |
| ||
| duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| DVT | Vascular disorders | Systematic Assessment |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| e. coli | Infections and infestations | Systematic Assessment |
| ||
| elevated INR | Investigations | Systematic Assessment |
| ||
| encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| endocarditis | Infections and infestations | Systematic Assessment |
| ||
| enlarged pulmonary artery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| enlarged scrotum | Reproductive system and breast disorders | Systematic Assessment |
| ||
| enterococcus | Infections and infestations | Systematic Assessment |
| ||
| ESRD | Renal and urinary disorders | Systematic Assessment |
| ||
| eye surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| femoral bypass surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| fever | General disorders | Systematic Assessment |
| ||
| fistulogram | Investigations | Systematic Assessment |
| ||
| flu | Infections and infestations | Systematic Assessment |
| ||
| folliculitis | Infections and infestations | Systematic Assessment |
| ||
| foot infection and pain | Infections and infestations | Systematic Assessment |
| ||
| fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| gallbladder infection | Infections and infestations | Systematic Assessment |
| ||
| gangrene | Infections and infestations | Systematic Assessment |
| ||
| gastrectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Grave's Disease | Immune system disorders | Systematic Assessment |
| ||
| h. pylori infection | Infections and infestations | Systematic Assessment |
| ||
| hand injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| hand pain and infection | Infections and infestations | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| hearing loss | Ear and labyrinth disorders | Systematic Assessment |
| ||
| heart attack | Cardiac disorders | Systematic Assessment |
| ||
| heart blockage | Cardiac disorders | Systematic Assessment |
| ||
| heart failure | Cardiac disorders | Systematic Assessment |
| ||
| heart surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| heart valve replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| hematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| hemorrhagic shock | Vascular disorders | Systematic Assessment |
| ||
| hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| hernia | General disorders | Systematic Assessment |
| ||
| hernia repair | Surgical and medical procedures | Systematic Assessment |
| ||
| hidradenitis axillaris | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| hidradenitis suppurativa | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HIV | Infections and infestations | Systematic Assessment |
| ||
| hospitalization | Surgical and medical procedures | Systematic Assessment |
| ||
| hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperlipidemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypervolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypervolemic hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypovolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ICA stenosis | Nervous system disorders | Systematic Assessment |
| ||
| ileostomy | Surgical and medical procedures | Systematic Assessment |
| ||
| ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| urine retention | Renal and urinary disorders | Systematic Assessment |
| ||
| infection | Infections and infestations | Systematic Assessment |
| ||
| inguinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| INR instability | Investigations | Systematic Assessment |
| ||
| internal defibrillator complication | Product Issues | Systematic Assessment |
| ||
| intraventricular hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| ischemic colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| IVC clot | Vascular disorders | Systematic Assessment |
| ||
| ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| kidney infection | Infections and infestations | Systematic Assessment |
| ||
| kidney failure | Renal and urinary disorders | Systematic Assessment |
| ||
| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| liver disease | Hepatobiliary disorders | Systematic Assessment |
| ||
| liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| lower extremity swelling | General disorders | Systematic Assessment |
| ||
| mania | Psychiatric disorders | Systematic Assessment |
| ||
| mastoiditis | Infections and infestations | Systematic Assessment |
| ||
| mesenteric thrombophlebitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| metabolic instability | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| metapneumovirus | Infections and infestations | Systematic Assessment |
| ||
| MRSA | Infections and infestations | Systematic Assessment |
| ||
| myasthenia gravis | Nervous system disorders | Systematic Assessment |
| ||
| myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| necrosis | General disorders | Systematic Assessment |
| ||
| nephrectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| neutrophic keratitis | Eye disorders | Systematic Assessment |
| ||
| non-traumatic L hyphema | Eye disorders | Systematic Assessment |
| ||
| NSTEMI | Cardiac disorders | Systematic Assessment |
| ||
| osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| pain | General disorders | Systematic Assessment |
| ||
| pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| paranoia | Psychiatric disorders | Systematic Assessment |
| ||
| parathyroidectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| pemphigus foliaceus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| percutaneous intervention | Surgical and medical procedures | Systematic Assessment |
| ||
| pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| peripheral artery disease | Vascular disorders | Systematic Assessment |
| ||
| peripheral neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| peritonitis | Infections and infestations | Systematic Assessment |
| ||
| pinched nerve | Nervous system disorders | Systematic Assessment |
| ||
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pneumonitis | Infections and infestations | Systematic Assessment |
| ||
| polycystic disease | Renal and urinary disorders | Systematic Assessment |
| ||
| polypharmacy | Investigations | Systematic Assessment |
| ||
| prostatitis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| pseudogout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pubic ramus injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pulmonary mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| rectal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| seizure | Nervous system disorders | Systematic Assessment |
| ||
| sepsis | Infections and infestations | Systematic Assessment |
| ||
| septic shock | Infections and infestations | Systematic Assessment |
| ||
| shingles | Infections and infestations | Systematic Assessment |
| ||
| shock | Vascular disorders | Systematic Assessment |
| ||
| shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| sickle cell disease | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| sigmoid ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| somnolence | Nervous system disorders | Systematic Assessment |
| ||
| spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| stab wounds | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| staph infection | Infections and infestations | Systematic Assessment |
| ||
| Steal Syndrome | Vascular disorders | Systematic Assessment |
| ||
| STEMI | Cardiac disorders | Systematic Assessment |
| ||
| streptococcus | Infections and infestations | Systematic Assessment |
| ||
| subgaleal hematoma | Vascular disorders | Systematic Assessment |
| ||
| subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| syncope | Nervous system disorders | Systematic Assessment |
| ||
| tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| thrombectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| ulcerative lichen planus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| unconsciousness | Nervous system disorders | Systematic Assessment |
| ||
| upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| volume shifts | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| weakness | General disorders | Systematic Assessment |
| ||
| wound infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Withdrawal symptoms | General disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Adverse effect from a medication starting to treat pain, depression or anxiety | General disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Opioid use disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Substance use disorder | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Kuzla | University of Pennsylvania | 2155732935 | nkuzla@pennmedicine.upenn.edu |
| Aug 1, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2022 | Aug 1, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| OG001 | Usual Care | Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| Usual Care |
Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| OG001 |
| Usual Care |
Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| OG001 |
| Usual Care |
Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
|
| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
|
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| Usual Care |
Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 |
| Usual Care |
Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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| OG001 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. |
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