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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, monthly for 24 weeks, weeks 36 and 48

Awards & highlights

SC-POWR Trial 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.Check my eligibility

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.See study design

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.

SC-POWR Trial 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.

SC-POWR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weekly for 24 weeks, weeks 36 and 48

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in composite illicit opioid use

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

Secondary outcome measures

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 outcome measures

Change in exercise levels

Change in fear avoidance

Change in pain catastrophizing

+10 more

SC-POWR 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,502 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,032 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities to join this investigation?

"Affirmative. According to the clinicaltrials.gov listing, this trial is actively looking for participants; it was first published on August 18th 2022 and has been revised as recently as August 22nd 2022. A total of 316 people are required from a single medical center."

Answered by AI

How many participants are eligible for inclusion in this research project?

"Affirmative. The records on clinicaltrials.gov demonstrate that this medical experiment, which was first posted on August 18th 2022, is currently enrolling patients. Approximately 316 participants need to be recruited from 1 research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stepped Care for Patients to Optimize Whole Recovery

2023. "Stepped Care for Patients to Optimize Whole Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155163.

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