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Behavioural Intervention

Cognitive Behavioral Therapy + Recovery Coaching for Opioid Use Disorder (OVERCOME 2 Trial)

N/A

Recruiting

Led By Alain H Litwin, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥18 years of age)

Currently receiving SL buprenorphine/ naloxone and/or buprenorphine HCL

Must not have

Have taken or received any prescribed buprenorphine product within 30 days prior to the current treatment episode.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding therapy & peer coaching to sublingual buprenorphine helps reduce illicit drug use. Outcomes will be compared in 3 arms: buprenorphine only, w/CBT4CBT, w/CBT4CBT & coaching. #DrugAbuse

Who is the study for?

Adults diagnosed with Opioid Use Disorder (OUD), currently on sublingual buprenorphine, and able to use a computer can join. They must be willing to be randomly assigned to a treatment group and have started buprenorphine within the last 30 days. Those with severe health or mental issues, pregnant or breastfeeding women, non-English speakers/readers, or those who've used prescribed buprenorphine in the past month cannot participate.

What is being tested?

The trial tests if adding computer-based cognitive behavioral therapy (CBT4CBT) alone or combined with peer recovery coaching improves outcomes for those on standard opioid addiction treatment with sublingual buprenorphine. It measures drug use reduction over an 8-week period and checks how well patients stick to their treatments up to six months later.

What are the potential side effects?

While this study primarily involves therapy interventions which typically do not have physical side effects like medications do, participants may experience emotional discomfort discussing substance use history during CBT sessions.

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 taking SL buprenorphine/naloxone or buprenorphine HCL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used a prescribed buprenorphine product in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Buprenorphine retention at 3-month follow-up

Buprenorphine retention at 6-month follow-up

Drug use

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard of care + CBT4CBT+ RCExperimental Treatment2 Interventions

This condition will integrate the standard of care, CBT4CBT, and recovery coaching services with Assertive Community Engagement (ACE) model interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs Peer recovery coaching services involve a form of nonclinical, peer support aimed at helping individuals with substance use disorders to achieve and maintain recovery. Recovery coaches are individuals with experience with substance use and successful recovery. In addition to their lived experience, recovery coaches obtain formal training on substance use coaching and receive ongoing supervision. The recovery coaches use an assertive engagement approach to provide holistic, person-centered, and strength-based support.

Group II: Standard of care + CBT4CBTExperimental Treatment1 Intervention

This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.

Group III: Standard of careActive Control1 Intervention

Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly, bi-weekly or monthly visits (at the discretion of the provider) in-person or virtually. This condition will be matched with the other conditions in terms of the number of research visits.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT4CBT

2017

Completed Phase 4

~430

0 / 3Eligibility criteria met