Improving pain management and treatment engagement for patients using opioids
Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
This study is testing a new phone or web program to help people with chronic pain and opioid misuse learn to manage their pain better and stay engaged in their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 378 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 9 sites (Pittsburgh, Pennsylvania and 8 other locations) |
| Trial ID | NCT06855732 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a Pain Self-Management (PSM) program for individuals with chronic pain who also have opioid misuse or opioid use disorder (OUD). Participants will be randomly assigned to either the PSM intervention or standard care for a duration of 12 weeks. The PSM program consists of 10 sessions delivered via phone or web, focusing on behavioral strategies to manage pain and enhance treatment engagement. Participants will complete surveys every three months for nine months to assess outcomes related to pain management and treatment engagement.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic pain and a diagnosis of opioid misuse or OUD.
Not a fit: Patients who do not have chronic pain or do not meet the criteria for opioid misuse or OUD may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and treatment adherence for patients struggling with opioid misuse.
How similar studies have performed: Other studies have shown promise in using behavioral interventions for pain management and opioid misuse, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania and 8 other locations
- Community Medicine, Inc. — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC General Internal Medicine-Montefiore — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC General Internal Medicine-Shadyside (Shea Medical Center) — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC General Internal Medicine-Turtle Creek — Turtle Creek, Pennsylvania, United States (Recruiting)
- UPMC General Internal Medicine-South — West Mifflin, Pennsylvania, United States (Recruiting)
- St. Joseph's Rural Health Clinic (WVU Medicine) — Buckhannon, West Virginia, United States (Not_yet_recruiting)
- Harpers Ferry Family Medicine (WVU Medicine) — Harpers Ferry, West Virginia, United States (Not_yet_recruiting)
- WVU Medicine University Town Centre — Morgantown, West Virginia, United States (Not_yet_recruiting)
- WVU Medicine Primary Care — Shepherdstown, West Virginia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Erin Winstanley, PhD — University of Pittsburgh
- Study coordinator: Melessa Salay, MPH
- Email: TREETOP@pitt.edu
- Phone: 412-648-7896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.