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Psychosocial Pain Management for Opioid Use Disorder (Persist Trial)

N/A

Waitlist Available

Led By Allison Lin, M.D., M.S.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12-months post enrollment

Awards & highlights

Persist Trial 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.Check my eligibility

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.See study design

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.

Persist Trial 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.

Persist Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12-months post enrollment

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

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

Secondary outcome measures

Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).

Pain

+2 more

Persist 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,799 Previous Clinical Trials

6,378,438 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

834 Previous Clinical Trials

669,268 Total Patients Enrolled

US Department of Veterans AffairsFED

869 Previous Clinical Trials

495,743 Total Patients Enrolled

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

Frequently Asked Questions

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

Does this experiment currently accept participants?

"Affirmative. Clinicaltrials.gov has the most recent data indicating that this research is currently in need of participants, with 200 individuals needed to be recruited from 2 locations since it was first posted on August 14th 2020 and last updated on September 22nd 2022."

Answered by AI

How many individuals are currently participating in this research study?

"Affirmative. The information on clinicaltrials.gov reveals that the medical trial, which had a commencement date of August 14th 2020, is actively enrolling participants. This study requires 200 people from 2 distinct sites to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Mark A. Ilgen 2020. "Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04433975.

All > Opioid Dependence > Chronic Pain