Stepped Care for Patients to Optimize Whole Recovery (SC-POWR)

Yale University

Status: Enrolling

Conditions: Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: SC-POWR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05155163

1RM1DA055310-01 (U.S. NIH Grant/Contract)

2000031094

Details and patient eligibility

About

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).

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Treatment as Usual

No Intervention group

Description:

Treatment as usual for opioid use disorder

SC-POWR

Experimental group

Description:

Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction

Treatment:

Behavioral: SC-POWR