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Psychosocial Pain Management for Opioid Use Disorder (Persist Trial)

N/A
Waitlist Available
Led By Mark Ilgen, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least moderate or greater self-reported pain on average over the past 3 months
Be older than 18 years old
Must not have
Buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12-months post enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether educational programs can help people with chronic pain and buprenorphine treatment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, psychosocial interventions may include temporary increases in emotional distress due to focusing on pain management techniques. Buprenorphine can cause side effects like dizziness, constipation, or withdrawal-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have experienced moderate to severe pain on average over the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am prescribed buprenorphine as a monthly shot or skin patch.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12-months post enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12-months post enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Retention on buprenorphine treatment according to TimeLine Follow-Back
Secondary study objectives
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
Pain
Pain
+1 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: Psychosocial Pain Management (PPMI)Experimental Treatment1 Intervention
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
Two individual telephone educational sessions with research study therapist.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,437,720 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
862 Previous Clinical Trials
673,901 Total Patients Enrolled
US Department of Veterans AffairsFED
873 Previous Clinical Trials
497,653 Total Patients Enrolled
Mark Ilgen, Ph.D.Principal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
12 Total Patients Enrolled
Allison Lin, M.D., M.S.Principal InvestigatorUniversity of Michigan

Media Library

Psychosocial Pain Management Clinical Trial Eligibility Overview. Trial Name: NCT04433975 — N/A
Opioid Use Disorder Research Study Groups: Enhanced Usual Care (EUC), Psychosocial Pain Management (PPMI)
Opioid Use Disorder Clinical Trial 2023: Psychosocial Pain Management Highlights & Side Effects. Trial Name: NCT04433975 — N/A
Psychosocial Pain Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04433975 — N/A
~37 spots leftby Dec 2025
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