Pain Self-Management and Treatment Engagement for Patients Taking Opioids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

NCT04693416

Stigma, Social Opioid Use Opioid-use Disorder +1 more

COMPLETED PHASE2

Medication Adherence Therapy for Opioid Abusing Pain Patients

NCT00249587

Pain Chronic Disease Prescription Opioid Abuse

COMPLETED PHASE1/PHASE2

Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

NCT02602535

Chronic Pain Opioid Use Disorders

COMPLETED NA

Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

NCT04433975

Opioid-use Disorder Medication Assisted Treatment Chronic Pain

COMPLETED NA

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

NCT06718491

Opioid Use Disorder

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is randomized trial of a pain self-management (PSM) intervention for chronic pain tailored to individuals with opioid misuse or opioid use disorder (OUD) as compared to usual care. The investigators hypothesize that PSM will be effective in improving both reducing pain and improving MOUD engagement among individuals with co-occurring opioid misuse/OUD and chronic pain.

This is a multisite trial recruiting from primary care clinics located in Pennsylvania, West Virginia and Maryland.

Interventions: Participants will be randomized to either PSM or Usual Care.

Pain Self-Management (PSM): PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.

Usual Care (UC): Usual care or "treatment as usual" refers to the standard of care that patient participants receive at their primary care clinic. The standard of care for patients is to discuss issues related to chronic pain and opioid use with their providers and to receive clinical care for these conditions.

Study Duration: \~27 months (18 months of recruitment + 9 months follow-up) Participant Duration: 9 months

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Opioid Use Disorder Opioid Misuse and Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1 to either PSM or Usual Care.

The intervention will be completed in 12 weeks and will take place between the baseline and 3-month (post-intervention) visit.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care

Usual care refers to the standard of care that patients receive at their primary care clinic.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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.

Pain Self-Management (PSM)

PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.

Group Type EXPERIMENTAL

Pain Self-Management

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adults at least 18 years old
2. Ability to speak, read, and understand English
3. Capable of providing informed consent
4. Access to phone and/or internet
5. Current (defined as at least 1 primary care visit in the past 3 years) or new (confirmed appointment) primary care patient at a participating clinic
6. Must meet criteria for OUD or opioid misuse based on at least one of the following:

1. OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
2. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
3. Documented diagnosis of Opioid use Disorder (OUD)
7. Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Under 18 years of age
2. Have cancer-related pain
3. Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
4. Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (\< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
5. Had an intentional suicide attempt within the past 3 months

The investigators will not exclude individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erin Winstanley

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erin Winstanley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renaissance Family Practice - Hampton Office

Allison Park, Pennsylvania, United States

Site Status RECRUITING

Renaissance Family Practice - RIDC Office

Blawnox, Pennsylvania, United States

Site Status RECRUITING