Stepped Care for Patients to Optimize Whole Recovery
Running, not enrolling · Not applicable
Conditions studied: Opioid Use Disorder, Chronic Pain
In brief
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).
Key facts
- Study ID
- NCT05155163
- Run by
- Yale University
- People needed
- 204
- Starts
- 2023-06-28
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- APT Foundation — New Haven, Connecticut, United States
- APT Foundation — North Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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