Stepped Care for Patients to Optimize Whole Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2026-08-31

Brief Summary

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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).

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Detailed Description

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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.

This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).

Conditions

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Opioid Use Disorder Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment as Usual

Treatment as usual for opioid use disorder

Group Type NO_INTERVENTION

No interventions assigned to this group

SC-POWR

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

Group Type EXPERIMENTAL

SC-POWR

Intervention Type BEHAVIORAL

Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.

Interventions

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SC-POWR

Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No