Psychosocial Pain Management for Opioid Use Disorder

(Persist Trial)

Recruiting at 1 trial location

Overseen By Mandy Lewis, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Buprenorphine

Disqualifiers: Pregnancy, Living outside US, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.

Research Team

Mark Ilgen, Ph.D.

Principal Investigator

University of Michigan

Allison Lin, M.D., M.S.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals who have been diagnosed with opioid use disorder in the last year, started buprenorphine treatment within the past six months, and suffer from moderate to severe chronic pain. Participants must have regular phone access for study sessions. Pregnant individuals or those living outside the US cannot participate.

Inclusion Criteria

I have experienced moderate to severe pain on average over the last 3 months.

You have started taking buprenorphine in the last 6 months.

You have been diagnosed with opioid use disorder in the last 12 months.

Exclusion Criteria

I am prescribed buprenorphine as a monthly shot or skin patch.

Self-reported pregnancy at the time of study enrollment

Currently living outside of the United States

Treatment Details

Interventions

• Enhanced Usual Care
• Psychosocial Pain Management

Trial Overview The study compares two approaches: Psychosocial Pain Management (PPMI), which includes education and strategies for managing pain and medication, versus Enhanced Usual Care (EUC) that participants currently receive. The goal is to see if PPMI can improve outcomes for those on buprenorphine therapy.

Participant Groups

Group I: Psychosocial Pain Management (PPMI) Experimental Treatment 1 Intervention

Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Two individual telephone educational sessions with research study therapist.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+