MedDataX Logo

Pain and Opioids: Integrated Treatment In Veterans

NCT ID: NCT04648228

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Opioid-use Disorder Opioids; Harmful Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACT + MBRP

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.

Group Type EXPERIMENTAL

ACT+MBRP

Intervention Type 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.

Education Control (EC)

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.

Group Type ACTIVE_COMPARATOR

Education control

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACT+MBRP

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.

Intervention Type BEHAVIORAL

Education control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Willing to comply with all study procedures and be available for the duration of the study
3. Male or female, aged 21 to 75 years.
4. Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
5. Presence of chronic pain for \> 6 months in duration.

Exclusion Criteria

1. Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
2. Unable to read English.
3. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Biomedical Research Institute of New Mexico

OTHER

Sponsor Role collaborator

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

San Francisco VA Health Care System

FED

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Francisco VA Health Care System

San Francisco, California, United States

Site Status

New Mexico VA Healthcare System

Albuquerque, New Mexico, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Puget Sound VA Healthcare System

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31760109 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36693589 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.1016/j.jpain.2019.11.007

Description of ACT+MBRP integrated treatment being tested in the current study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1UG3DA051241-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A20-0217

Identifier Type: OTHER

Identifier Source: secondary_id

1507090

Identifier Type: -

Identifier Source: org_study_id