RECRUITING

Stepped Care for Patients to Optimize Whole Recovery

Description

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).

Conditions

Opioid Use DisorderChronic Pain
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Related Conditions:

Opioid Use DisorderChronic Pain

Study Overview

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Study Details

Study 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).

Stepped Care for Patients to Optimize Whole Recovery

Stepped Care for Patients to Optimize Whole Recovery

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

New Haven

APT Foundation, New Haven, Connecticut, United States, 06520

North Haven

APT Foundation, North Haven, Connecticut, United States, 06473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Declan Barry, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-08-31