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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA051241-01 | U.S. NIH Grant/Contract | View source | |
| A20-0217 | Other Identifier | Cayuse Project Number |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Utah | OTHER |
| Johns Hopkins University | OTHER |
| Duke University |
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This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT + MBRP]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.
There is compelling data that chronic pain and hazardous opioid use, considered individually, are significant and costly healthcare burdens in both veteran and nonveteran populations in the United States (US). When these two diagnoses are considered together, they appear to occur in a clinically significant proportion of patients. Further, opioid use disorder (OUD) interferes with chronic pain treatment outcomes and continued pain interferes with OUD outcomes treatment. While buprenorphine is effective for the treatment of pain and OUD, retention, relapse, and continued pain interference is not addressed through treatment with buprenorphine alone. Integrated treatments that target the key outcomes for both conditions, specifically pain's interference on functioning and opioid misuse/relapse, as developed in our prior work, allows for a parsimonious and efficacious way of providing treatment. Our recently completed pilot study indicated that such an integrated treatment was feasible and more effective than treatment as usual. To study this further, a multisite clinical trial comparing a three month integrated behavioral treatment that combines Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, as compared to an education control will be conducted with 160 veterans recruited from three VA Health Care Systems who have been stabilized on buprenorphine for the treatment of OUD. To assess longer-term outcomes, participants will be followed for 1 year after completion of the 3 month intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT + MBRP | Experimental | Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform. |
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| Education Control (EC) | Active Comparator | The EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT+MBRP | Behavioral | Intervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain interference | Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items. | Post-Treatment (month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale. | Post-Treatment (month 3) |
| Change in pain intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Social role functioning | PROMIS, Social Role Functioning via 8 self-report items. | Post-Treatment (month 3) |
| Change in social role functioning | PROMIS, Social Role Functioning via 8 self-report items. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Health Care System | San Francisco | California | 94121 | United States | ||
| New Mexico VA Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31760109 | Background | Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21. | |
| 36693589 | Derived | Vowles KE, Witkiewitz K, Clarke E, Schmidt Z, Borsari B, Edwards KE, Korecki JR, Moniz-Lewis DI, Bondzie JA, Mullins C, Thoreson CI, Delacruz J, Wilkins CH, Nelson S, Delventura J, Henderson R, Katz A, Hua W, Watson E, Baxley C, Canlas BR, Pendleton T, Herbst E, Batki S. Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Contemp Clin Trials. 2023 Mar;126:107096. doi: 10.1016/j.cct.2023.107096. Epub 2023 Jan 21. |
| Label | URL |
|---|---|
| Description of ACT+MBRP integrated treatment being tested in the current study. | View source |
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It is expected that all data collected by award recipients and their collaborators, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding.
At the time of publication of the primary manuscript, or within 12 months of last patient procedure
Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Vanderbilt University | OTHER |
| Biomedical Research Institute of New Mexico | OTHER |
| Seattle Institute for Biomedical and Clinical Research | OTHER |
| Queen's University, Belfast | OTHER |
| University of California, San Francisco | OTHER |
| San Francisco VA Health Care System | FED |
This trial will determine the efficacy of an integrated Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention (ACT+MBRP) treatment program for veterans with co-occurring chronic pain and opioid use disorder (OUD) who are prescribed buprenorphine, compared to an education control (EC) consisting of pain, opioid, and buprenorphine education. To test the efficacy of ACT + MBRP compared to EC with regard to primary and secondary outcomes, participants will be randomized to one of 2 treatment arms and followed for a total of 15 months (3-month active treatment period, 6 month follow-up, 12 month follow-up). All study treatments will be delivered via the VA Video Connect telehealth platform.
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Principal Investigators will be blinded. Co-investigators and study physicians involved in the treatment and control conditions will not be blinded, as these individuals will handle the delivery of treatment. The study coordinators located within each VA will not be blinded, as they will be involved in coordinating participant screening and randomization. Data analysis will be conducted by a study statistician blinded to participant condition.
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| Education control | Behavioral | Education control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs. |
|
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale.
| Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Opioid misuse | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. | Post-Treatment (month 3) |
| Depression | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. | Post-Treatment (month 3) |
| Change in depression | Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Pain-related Fear | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. | Post-Treatment (month 3) |
| Change in pain-related Fear | Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Alcohol and other drug use | Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance). | Post-Treatment (month 3) |
| Change in alcohol and other drug use | Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance). | Monthly. |
| Change in Pain interference | Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Change in opioid misuse | Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items. | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Psychosocial Impact of Illness | PROMIS, Psychosocial Impact of Illness via 8 self-report items | Post-Treatment (month 3) |
| Change in psychosocial Impact of Illness | PROMIS, Psychosocial Impact of Illness via 8 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Physical Functioning | PROMIS, Physical Functioning via 6 self-report items | Post-Treatment (month 3) |
| Change in Physical Functioning | PROMIS, Physical Functioning via 6 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Alcohol Use | Alcohol Use Disorders Identification Test, 10 self-report items | Post-Treatment (month 3) |
| Change in Alcohol Use | Alcohol Use Disorders Identification Test, 10 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Post-Traumatic Disorder Symptoms | PTSD Checklist-5, 20 self-report items | Post-Treatment (month 3) |
| Change in Post-Traumatic Disorder Symptoms | PTSD Checklist-5, 20 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Generalized Anxiety | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items | Post-Treatment (month 3) |
| Change in Generalized Anxiety | Generalized Anxiety Disorders Test (GAD-7), 7 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Sleep Disturbance | PROMIS, Sleep Disturbance via 6 items | Post-Treatment (month 3) |
| Change in Sleep Disturbance | PROMIS, Sleep Disturbance via 6 items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Pain Catastrophizing | Pain Catastrophizing Scale - Short Form, 6 self-report items | Post-Treatment (month 3) |
| Change in Pain Catastrophizing | Pain Catastrophizing Scale - Short Form, 6 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Substance use | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items | Post-Treatment (month 3) |
| Change in Substance use | Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Patient Global Impression of Change | Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Post-Treatment (month 3) |
| Change in Patient Global Impression of Change | Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups |
| Albuquerque |
| New Mexico |
| 87108 |
| United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Puget Sound VA Healthcare System | Tacoma | Washington | 98493 | United States |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |