Stepped Care for Patients to Optimize Whole Recovery
Active, not recruitingNot applicableNCT05155163
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise \[Wii Fit, Tai Chi\] and stress reduction \[relaxation training, auricular acupuncture\] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).
Study details
- Official title
- Stepped Care for Patients to Optimize Whole Recovery
- Conditions
- Interventions
- Behavioral: SC-POWR
- Sponsor
- Yale University
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2023-06-28
- Primary completion
- 2026-08-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05155163