Pain Self-Management and Treatment Engagement for Patients Taking Opioids

Summary

The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are:

* Does PSM help participants manage their chronic pain more effectively?
* Does PSM help participants engage in treatment for opioid use?

Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.

Participants will:

* Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study
* Complete surveys every 3 months for 9 months (total of 4 visits)

Participants will receive compensation for participating in the study.

There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.

Conditions

• Chronic Pain
• Opioid Use Disorder
• Opioid Misuse and Addiction

Interventions

BEHAVIORAL

Usual Care

Usual care refers to the standard of care that patients receive at their primary care clinic. The standard of care for patients is to discuss chronic pain with their providers at their discretion, and for providers to offer buprenorphine for OUD and/or provide referrals to specialty addiction treatment programs in the local community. Participants will continue to have access to usual care for chronic pain, which could include pain clinic visits, physical therapy, medication (e.g., gabapentin), and/or seeing a counselor, psychiatrist, or psychologist. The study protocol will not interfere with usual clinical care.

BEHAVIORAL

Pain Self-Management

PSM is a manualized behavioral intervention tailored to patients in primary care with opioid misuse/OUD. The PSM intervention that consists of ten sessions/modules. Participants will be offered a total of 10 PSM sessions, delivered weekly over a 12-week intervention period starting from the date of study enrollment. A trained staff interventionist will lead the 60-minute sessions using a participant study manual that outlines the content for all 10 sessions. The first two sessions, "Introduction" and "Navigating Conversations About Opioids", are mandatory. Participants can choose the order of the remaining 8 sessions, prioritizing those they are most interested in. Additional session topics are: Stress Management and Your Pain, Relaxation Techniques to Help Your Pain, Thinking Differently About Your Pain, Sleeping Better to Help Your Pain, Physical Activity and Your Pain, Mood and Your Pain, and Communicating with Others.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Erin Winstanley, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-25

Primary Completion

2026-07-31

Completion

2026-12-31

Countries

• United States

Study Locations