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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT010106 | U.S. NIH Grant/Contract | View source | |
| R01AT010797 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| US Department of Veterans Affairs | FED |
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The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Experimental | Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. |
|
| Enhanced Usual Care (EUC) | Active Comparator | Two individual telephone educational sessions with research study therapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Behavioral | The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months | In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up. | 3-months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months | In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 12 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 12-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Lin, M.D., M.S. | University of Michigan | Principal Investigator |
| Mark Ilgen, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affair Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States | ||
| Michigan Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40972890 | Derived | Ilgen M, Blow F, Piette JD, Goldstick J, Lewis M, Priest W, Matharu H, Bourgoise M, Young C, Ashe D, Price A, Lin LA. The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Nov;158:108081. doi: 10.1016/j.cct.2025.108081. Epub 2025 Sep 17. |
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IRB approval from the University of Michigan (UM) was obtained in February 2020 with remote recruitment changes approved in June 2020. Several of the recruitment strategies used were in person recruitment at local buprenorphine clinics; posted flyers at community locations; targeted advertising on Facebook, Instagram, and Craigslist; posts on the UMHealthResearch.org page; advertising on websites that target patients in recovery; review of health records at UM and Ann Arbor VA Healthcare System
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychosocial Pain Management (PPMI) | Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment. |
| FG001 | Enhanced Usual Care (EUC) | Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Baseline and Randomized |
| |||||||||||||
| 1-month Follow Up |
| |||||||||||||
| 3-month Follow Up |
| |||||||||||||
| 6-month Follow Up |
| |||||||||||||
| 9-month Follow Up |
| |||||||||||||
| 12-month Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychosocial Pain Management (PPMI) | Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months | In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up. | Posted | Mean | Standard Deviation | days | 3-months post enrollment |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychosocial Pain Management (PPMI) | Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - psych | Psychiatric disorders | Systematic Assessment | Hospitalization due to psychiatric concerns |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Medical Visit | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Ilgen | University of Michigan Medical School | 734-845-3646 | marki@med.umich.edu |
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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 | Nov 10, 2023 | May 13, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2023 | May 13, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Enhanced Usual Care (EUC) | Behavioral | The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence. |
|
| 12-months post enrollment |
| Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline) | Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0=no pain, 10= worst pain imaginable), which will be collected at the baseline enrollment assessment and 3-month follow-up. To calculate our measure, we subtracted each participant's score at 3-month assessment and subtracted it from their baseline score. We then averaged calculated average change in scores for each intervention group. | 3-months post enrollment |
| Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline) | Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 3-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | 3-months post enrollment |
| Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months | Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at 3-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 3 months follow-up. | 3-months post enrollment |
| Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline) | Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 12-month follow-up. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | 12-months post enrollment |
| Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline) | Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 12-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | 12-months post enrollment |
| Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months | Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the 12-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 12 months follow-up. | 12-months post enrollment |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| COMPLETED | Completed = number of participants that completed the timepoint survey. |
|
| NOT COMPLETED |
|
|
| COMPLETED | Completed = number of participants that completed the timepoint survey. |
|
| NOT COMPLETED |
|
|
| COMPLETED | Completed = number of participants that completed the timepoint survey. |
|
| NOT COMPLETED |
|
|
| COMPLETED | Completed = number of participants that completed the timepoint survey. |
|
| NOT COMPLETED |
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| COMPLETED | Completed = number of participants that completed the timepoint survey. |
|
| NOT COMPLETED |
|
|
| BG001 | Enhanced Usual Care (EUC) | Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Military Status | Self-identified yes/no to "Have you ever been in the United States Armed Forces?" | Count of Participants | Participants |
|
| Brief Pain Inventory (BPI) Score | Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). | Mean | Standard Deviation | units on a scale |
|
| Percent days abstinent | During the TimeLine Follow Back assessment at baseline, participants reported their daily substance use for the past 6 months. The team calculated the average percentage of days that participants did not use substances within the 6-month period prior to their baseline assessment ((# of days abstinent )/(# of baseline days assessed)*100). | Mean | Standard Deviation | percent |
|
| Numeric Rating Scale (NRS-I) Score | Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). | Mean | Standard Deviation | units on a scale |
|
| Rapid Opioid Dependence Screen (RODS) | RODS is an 8-item measure based on the DSM criteria that is used to quickly assess opioid dependence among adults. RODS assesses lifetime use of opioids such as heroin, methadone, buprenorphine, oxycontin, and other opioid analgesics, and asks questions measuring physiological, behavioral, and cognitive factors associated with opioid use. RODS uses binary (yes/no) responses that are summed to create the summary measure. Summary scores range from 0 - 8, with "Yes" responses to three or more questions (or a score of 3 or more) suggesting the presence of a probable opioid use disorder. | Mean | Standard Deviation | units on a scale |
|
| Severity of Opioid Use Disorder | Measurement of the severity of opioid use disorder as indicated by the Structured Clinical Interview for DSM-5. | Count of Participants | Participants |
|
| OG001 | Enhanced Usual Care (EUC) | Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence. |
|
|
| Secondary | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months | In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 12 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 12-month follow-up. | Posted | Mean | Standard Deviation | days | 12-months post enrollment |
|
|
|
| Secondary | Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline) | Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0=no pain, 10= worst pain imaginable), which will be collected at the baseline enrollment assessment and 3-month follow-up. To calculate our measure, we subtracted each participant's score at 3-month assessment and subtracted it from their baseline score. We then averaged calculated average change in scores for each intervention group. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | score on a scale | 3-months post enrollment |
|
|
|
| Secondary | Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline) | Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 3-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | score on a scale | 3-months post enrollment |
|
|
|
| Secondary | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months | Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at 3-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 3 months follow-up. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | percent of days | 3-months post enrollment |
|
|
|
| Secondary | Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline) | Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 12-month follow-up. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | score on a scale | 12-months post enrollment |
|
|
|
| Secondary | Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline) | Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 12-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | score on a scale | 12-months post enrollment |
|
|
|
| Secondary | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months | Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the 12-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 12 months follow-up. | Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question. | Posted | Mean | Standard Deviation | percent of days | 12-months post enrollment |
|
|
|
| 1 |
| 98 |
| 20 |
| 98 |
| 10 |
| 98 |
| EG001 | Enhanced Usual Care (EUC) | Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence. | 1 | 102 | 16 | 102 | 7 | 102 |
|
| Hospitalization - general medical | General disorders | Systematic Assessment | General medical care for pain or injuries |
|
| Car Accident | General disorders | Systematic Assessment |
|
| Detox | General disorders | Systematic Assessment |
|
| Residential Substance Use Treatment | General disorders | Systematic Assessment |
|
| Injury - Fall | General disorders | Systematic Assessment |
|
Not provided
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |