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Stepped Care for Patients to Optimize Whole Recovery

Stepped Care for Patients to Optimize Whole Recovery

Recruiting
18 years and older
All
Phase N/A

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Overview

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).

Description

Participants who meet criteria for CP and OUD (N=204) will be initiated onto MOUD and randomized to 24 weeks of either treatment as usual (TAU) or 24 weeks of SC-POWR. SC-POWR patients will be "stepped up" according to a priori criteria. Patients randomized to SC-POWR will receive a behavioral intervention consisting of 12 Cognitive Behavioral Therapy (CBT) sessions over a 24-week period involving improvements in substance use and pain since baseline. Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups.

Eligibility

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

Study details
    Opioid Use Disorder
    Chronic Pain

NCT05155163

Yale University

29 April 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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