A program to improve recovery for patients with opioid use disorder and chronic pain
Stepped Care for Patients to Optimize Whole Recovery
NA · Yale University · NCT05155163
This study is testing a new recovery program for people with opioid use disorder and chronic pain to see if it helps them feel better and manage their pain more effectively compared to standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05155163 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 204 patients with opioid use disorder and chronic pain, comparing standard treatment with a new approach called Stepped Care for Patients to Optimize Whole Recovery (SC-POWR). Participants will receive medications for opioid use disorder and be randomized to either standard treatment or SC-POWR, which includes cognitive behavioral therapy, exercise, and stress reduction techniques over 24 weeks. The study aims to assess the effectiveness of SC-POWR in reducing pain interference and improving various mental health outcomes. Participants will be followed for an additional 24 weeks to evaluate the long-term effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals seeking treatment for opioid use disorder who also experience chronic pain that impacts their daily life.
Not a fit: Patients with acute psychiatric conditions or those requiring immediate surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients struggling with both opioid use disorder and chronic pain.
How similar studies have performed: Other studies have shown promise in using stepped care models for addiction and pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Seeking treatment at APT Foundation * Receiving medications for opioid use disorder (MOUD provided by APT) * Have high impact chronic pain (\>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work) * Meet DSM-5 criteria for moderate to severe OUD * In the past 2 months, has an opioid-positive urine test or self-reports opioid use * Understand English * Able to provide informed consent Exclusion Criteria: * Have pending surgery or invasive pain management procedure * Acutely psychotic, suicidal, or homicidal * Psychiatric instability (e.g., recent suicide attempt) * Have a contraindication to exercise (e.g. complete heart block) * Have a pending or planned relocation or pending incarceration
Where this trial is running
New Haven, Connecticut and 1 other locations
- APT Foundation — New Haven, Connecticut, United States (RECRUITING)
- APT Foundation — North Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Declan Barry — Yale University
- Study coordinator: Declan Barry, PhD
- Email: declan.barry@yale.edu
- Phone: 203-285-2708
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.
Conditions: Opioid Use Disorder, Chronic Pain