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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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

POSITIVE Trial 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.Check my eligibility

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.See study design

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.

POSITIVE Trial Eligibility Criteria

Inclusion Criteria

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

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

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

POSITIVE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid misuse

Pain interference

Secondary outcome measures

Alcohol and other drug use

Change in Pain interference

Change in alcohol and other drug use

+7 more

Other outcome measures

Alcohol Use

Change in Alcohol Use

Change in Generalized Anxiety

+17 more

POSITIVE 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER

2,263 Previous Clinical Trials

14,823,005 Total Patients Enrolled

University of California, San FranciscoOTHER

2,505 Previous Clinical Trials

15,237,395 Total Patients Enrolled

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,629 Total Patients Enrolled

Media Library

ACT+MBRP Clinical Trial Eligibility Overview. Trial Name: NCT04648228 — N/A

Opioid Use Disorder Research Study Groups: ACT + MBRP, Education Control (EC)

Opioid Use Disorder Clinical Trial 2023: ACT+MBRP Highlights & Side Effects. Trial Name: NCT04648228 — N/A

ACT+MBRP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648228 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being welcomed as participants in this investigation?

"The age range for eligible participants in this trial is between 21 and 75 years old. By contrast, there are 51 trials available to minors while 571 studies are open to seniors."

Answered by AI

Is it possible to volunteer for this research initiative?

"This trial aims to enrol 160 individuals aged 21-75 that are suffering from chronic pain. To be considered, participants must agree to abide by the study's protocols for its full duration and have been prescribed a stable dosage of buprenorphine for at least one month but no more than six months prior to recruitment. Additionally, those applying must already be patients in participating VA Co-Occurring Disorders clinics with documented cases of prolonged discomfort (>6 months)."

Answered by AI

Are there currently any openings for participants in this trial?

"Affirmative. According to the information uploaded onto clinicaltrials.gov, this medical trial is actively recruiting participants and was first posted on July 1st 2021. The study has been edited as recently April 18th 2022 and needs 160 individuals from 4 different sites."

Answered by AI

What are the objectives of this experiment?

"The primary efficacy measure of this trial is Pain Interference, assessed at the Post-Treatment stage (month 3). Secondary metrics include Change in Pain Intensity (as measured on a 0 to 10 Numerical Rating Scale), Depression levels as indexed by Patient Health Questionnaire 9 scores, and subsequent changes in depression."

Answered by AI

What is the cap on the number of research participants in this experiment?

"A total of 160 eligible individuals must sign up for this study. Participants have the option to join from University of New mexico in Tacoma, Washington or Puget Sound VA Healthcare System in San Francisco, California."

Answered by AI

Recent research and studies

The Journal of PainJournal

Integrated Behavioral Treatment for Veterans with Co-morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial

Vowles, Kevin E., Katie Witkiewitz, Karen J. Cusack, Wesley P. Gilliam, Karen E. Cardon, Sarah Bowen, Karlyn A. Edwards, Mindy L. McEntee, and Robert W. Bailey. 2020. “Integrated Behavioral Treatment for Veterans with Co-morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2019.11.007.

clinicaltrials.govStudy

Pain and Opioids: Integrated Treatment In Veterans

2021. "Pain and Opioids: Integrated Treatment In Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04648228.

All > Opioid Dependence > Chronic Pain