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Behavioral Intervention

Stepped Care for Opioid Use Disorder and Chronic Pain (SC-POWR Trial)

N/A
Recruiting
Led By Declan Barry
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 18 years old
Receiving medications for opioid use disorder (MOUD provided by APT)
Must not have
Have pending surgery or invasive pain management procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, monthly for 24 weeks, weeks 36 and 48
Awards & highlights

Summary

This trial is testing a new treatment for opioid use disorder and chronic pain, which includes cognitive behavioral therapy, medication, and onsite groups for exercise and stress reduction. The goal is to reduce illicit opioid use and pain interference, and improve sleep, anxiety, depression, and stress.

Who is the study for?
This trial is for adults over 18 with opioid use disorder and chronic pain that disrupts daily life. They must be seeking treatment, understand English, consent to participate, and have been on medications for opioid use disorder for less than a year. Excluded are those planning surgeries or moves, experiencing acute psychosis or suicidal thoughts, or unable to exercise due to health reasons.
What is being tested?
The study compares usual treatment with SC-POWR—a combination of cognitive behavioral therapy (CBT), medication-assisted treatment (MOUD), and group activities like Wii Fit, Tai Chi, relaxation training, and auricular acupuncture—over a period of 24 weeks followed by another 24-week evaluation phase.
What are the potential side effects?
While the trial doesn't involve new drugs that might cause typical side effects, interventions like CBT could bring up emotional discomfort initially. Exercise groups may lead to muscle soreness or injury if not done properly. Acupuncture has risks such as minor bleeding or bruising at needle sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am currently receiving medication for opioid addiction.
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I have constant pain that affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery or a procedure to manage pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly for 24 weeks, weeks 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly for 24 weeks, weeks 36 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in composite illicit opioid use
Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale
Secondary study objectives
Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Change in alcohol use
+3 more
Other study objectives
Change in exercise levels
Change in fear avoidance
Change in pain catastrophizing
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SC-POWRExperimental Treatment1 Intervention
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Group II: Treatment as UsualActive Control1 Intervention
Treatment as usual for opioid use disorder

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,733 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,060 Total Patients Enrolled
Declan BarryPrincipal InvestigatorYale School of Medicine

Media Library

SC-POWR (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05155163 — N/A
Opioid Use Disorder Research Study Groups: SC-POWR, Treatment as Usual
Opioid Use Disorder Clinical Trial 2023: SC-POWR Highlights & Side Effects. Trial Name: NCT05155163 — N/A
SC-POWR (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155163 — N/A
~134 spots leftby Aug 2025
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