NCT05155163

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2023Aug 2026

First Submitted

Initial submission to the registry

December 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

December 7, 2021

Last Update Submit

April 21, 2026

Conditions

Chronic PainOpioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale

    Pain interference is measured using the PEG scale, a 3-item scale with each item scored from 0-10. Total scores are achieved by averaging the 3 items. Total sore range from 0-10. Higher scores indicate more pain and interference.

    Baseline, weekly for 24 weeks, weeks 36 and 48

Secondary Outcomes (7)

  • Change in alcohol use

    Baseline, weekly for 24 weeks, weeks 36 and 48

  • Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)

    Baseline, weekly for 24 weeks, weeks 36 and 48

  • Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

    Baseline, monthly for 24 weeks, weeks 36 and 48

  • Change in pain intensity assessed using the Brief Pain Inventory (BPI)

    Baseline, weekly for 24 weeks, weeks 36 and 48

  • Change in sleep

    Baseline, weekly for 24 weeks, weeks 36 and 48

  • +2 more secondary outcomes

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Treatment as usual for opioid use disorder

SC-POWR

EXPERIMENTAL

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

Behavioral: SC-POWR

Interventions

SC-POWRBEHAVIORAL

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

SC-POWR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APT Foundation

New Haven, Connecticut, 06520, United States

Location

APT Foundation

North Haven, Connecticut, 06473, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersChronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Declan Barry

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 13, 2021

Study Start

June 28, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)