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NCT05155163 · ClinicalTrials.gov registry record · NA
Stepped Care for Patients to Optimize Whole Recovery
A NA study of Chronic Pain and Opioid Use Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 2
- Study locations
NCT05155163: Recruiting NA study of Chronic Pain and Opioid Use Disorder, sponsored by Yale University.
NCT05155163 is a NA study of Chronic Pain and Opioid Use Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 204 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155163, a NA study of Chronic Pain and Opioid Use Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
Pain interference is measured using the PEG scale, a 3-item scale with each item scored from 0-10. Total scores are achieved by averaging the 3 items. Total sore range from 0-10. Higher scores indicate more pain and interference.
Conditions Studied
Interventions
- BEHAVIORAL SC-POWR
Study Locations (2)
Connecticut
- APT Foundation - New Haven
- APT Foundation - North Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2023-06-28 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT05155163 shows while recruiting
NCT05155163 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 1 intervention - of which SC-POWR is the first listed.
NCT05155163 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05155163 about?
NCT05155163 is a clinical study titled "Stepped Care for Patients to Optimize Whole Recovery". 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 ...
What is the current status of trial NCT05155163?
This trial is currently recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2023-06-28. Estimated completion is 2026-08-31.
What conditions does trial NCT05155163 study?
This clinical trial studies the following conditions: Chronic Pain, Opioid Use Disorder.
What interventions are being tested in trial NCT05155163?
The interventions under investigation include: SC-POWR (BEHAVIORAL).
Who is sponsoring clinical trial NCT05155163?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05155163 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05155163's enrollment target sits among peer trials
204 80th of 301 higher than 221 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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