Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (Persist)

University of Michigan

Status: Completed

Conditions: Opioid-use Disorder; Chronic Pain; Medication Assisted Treatment

Treatments: Behavioral: Psychosocial Pain Management (PPMI); Behavioral: Enhanced Usual Care (EUC)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04433975

R01AT010797 (U.S. NIH Grant/Contract)

R33AT010106 (U.S. NIH Grant/Contract)

HUM00166747

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• having a diagnosis of an opioid use disorders (OUD) within the past 12 months;
• started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months
• at least moderate or greater self-reported pain on average over the past 3 months;
• regular and consistent access to a telephone and willingness to use the phone for study sessions.

Exclusion criteria

• buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
• self-reported pregnancy at the time of study enrollment
• currently living outside of the United States

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Psychosocial Pain Management (PPMI)

Experimental group

Description:

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

Treatment:

Behavioral: Psychosocial Pain Management (PPMI)

Enhanced Usual Care (EUC)

Active Comparator group

Description:

Two individual telephone educational sessions with research study therapist.

Treatment:

Behavioral: Enhanced Usual Care (EUC)