Pain and Opioids: Integrated Treatment In Veterans
POSITIVE
Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder
3 other identifiers
interventional
157
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jul 2021
Longer than P75 for not_applicable chronic-pain
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 1, 2020
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedDecember 22, 2025
December 1, 2025
4.5 years
June 18, 2020
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (11)
Pain intensity
Post-Treatment (month 3)
Change in pain intensity
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Opioid misuse
Post-Treatment (month 3)
Depression
Post-Treatment (month 3)
Change in depression
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
- +6 more secondary outcomes
Other Outcomes (20)
Social role functioning
Post-Treatment (month 3)
Change in social role functioning
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Psychosocial Impact of Illness
Post-Treatment (month 3)
- +17 more other outcomes
Study Arms (2)
ACT + MBRP
EXPERIMENTALAcceptance 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.
Education Control (EC)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Stabilized on a dose of buprenorphine for a period of at least 1 month and less than six months. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 21 to 75 years.
- Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
- Presence of chronic pain for \> 6 months in duration.
You may not qualify if:
- Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- Unable to read English.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Mexicolead
- National Institute on Drug Abuse (NIDA)collaborator
- University of Utahcollaborator
- Johns Hopkins Universitycollaborator
- Duke Universitycollaborator
- Vanderbilt Universitycollaborator
- Biomedical Research Institute of New Mexicocollaborator
- Seattle Institute for Biomedical and Clinical Researchcollaborator
- Queen's University, Belfastcollaborator
- University of California, San Franciscocollaborator
- San Francisco VA Health Care Systemcollaborator
Study Sites (4)
San Francisco VA Health Care System
San Francisco, California, 94121, United States
New Mexico VA Healthcare System
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
Related Publications (2)
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.
PMID: 31760109BACKGROUNDVowles 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.
PMID: 36693589DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
December 1, 2020
Study Start
July 1, 2021
Primary Completion
December 16, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- At the time of publication of the primary manuscript, or within 12 months of last patient procedure
- Access Criteria
- Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy
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.