← Back to Search

ACT + MBRP for Chronic Pain and Opioid Abuse (POSITIVE Trial)

N/A

Recruiting

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Presence of chronic pain for > 6 months in duration.

Must not have

Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine whether an integrated treatment of Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention can reduce pain interference and substance misuse in veterans with chronic pain and opioid use disorder, compared to an education control consisting of education sessions on chronic pain, opioids, and buprenorphine use.

Who is the study for?

This trial is for veterans aged 21-75 with chronic pain who are taking buprenorphine for opioid use disorder (OUD) and have been on a stable dose for 1-6 months. Participants must be enrolled in VA Co-Occurring Disorders clinics, willing to follow the study plan, and available throughout the study. Those with severe mental health conditions or substance use disorders needing intense treatment cannot join.

What is being tested?

The trial tests an integrated therapy combining Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention (ACT+MBRP) against an education control program about chronic pain and opioids. The goal is to see if ACT+MBRP better reduces pain interference and prevents substance misuse compared to just getting educational sessions.

What are the potential side effects?

While specific side effects are not listed, interventions like ACT+MBRP may cause emotional discomfort due to confronting painful thoughts or feelings during therapy sessions. The education control is unlikely to have physical side effects but could also cause some distress if sensitive topics are discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on a stable dose of buprenorphine for 1 to 6 months.

Select...

I have been experiencing chronic pain for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need more than outpatient care for my severe substance use disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly.

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid misuse

Pain interference

Secondary study objectives

Alcohol and other drug use

Change in Pain interference

Change in alcohol and other drug use

+7 more

Other study objectives

Alcohol Use

Change in Alcohol Use

Change in Generalized Anxiety

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACT + MBRPExperimental Treatment1 Intervention

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 II: Education Control (EC)Active Control1 Intervention

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.

0 / 3Eligibility criteria met