Stepped Care for Patients to Optimize Whole Recovery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
APT Foundation
RECRUITING
New Haven
APT Foundation
RECRUITING
North Haven
Contact Information
Primary
Declan Barry, PhD
declan.barry@yale.edu
203-285-2708
Backup
Svetlana Vassilieva
svetlana.vassilieva@yale.edu
203-435-2497
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 204
Treatments
No_intervention: Treatment as Usual
Treatment as usual for opioid use disorder
Experimental: SC-POWR
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Yale University

This content was sourced from clinicaltrials.gov