Pain and Opioids: Integrated Treatment In Veterans

NCT04648228 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of Utah

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • Vanderbilt University

    collaborator OTHER
  • Biomedical Research Institute of New Mexico

    collaborator OTHER
  • Seattle Institute for Biomedical and Clinical Research

    collaborator OTHER
  • Queen's University, Belfast

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • San Francisco VA Health Care System

    collaborator FED
  • University of New Mexico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-12-16
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648228 on ClinicalTrials.gov