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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 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.

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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).

Interventions

  • BEHAVIORAL SC-POWR

Study Locations (2)

Connecticut

  • APT Foundation - New Haven
  • APT Foundation - North Haven

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2023-06-28
Est. Completion 2026-08-31
Phase NA

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT05155163

The ClinicalTrials.gov registry entry for NCT05155163 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (74% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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