CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: CBT4CBT-Buprenorphine + Recovery Coach

• Registration Number: NCT04824404
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.

Detailed Description

In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• adults (≥18 years)
• having a DSM-V diagnosis of OUD
• sublingual buprenorphine/naloxone and/or buprenorphine
• having initiated maintenance treatment for OUD for at least 30 days before the screening
• self-report or toxicology screening positive for any substance within 30 days of screening;
• willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
• having adequate computer skills

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Exclusion Criteria

• having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
• being pregnant or breastfeeding;
• being unable to independently read and/or comprehend the consent form or other study materials
• being unable to read/speak English;
• having current suicidal ideation based on the Patient Health Questionnaire-9.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT4CBT-Buprenorphine + Recovery Coach	CBT4CBT-Buprenorphine + Recovery Coach	This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional

Primary Outcome Measures

Name	Time	Method
Change in drug use	0-8 weeks	Using saliva toxicology tests

Secondary Outcome Measures

Name	Time	Method
Retention to buprenorphine	3 month follow up	enrollment in and receiving buprenorphine and/or other effective medication treatment for OUD which will be verified by either report from the treatment clinic or electronic medical record
Change in drug use	1 and 3 month follow up	Using saliva toxicology tests

Trial Locations

Locations (1)

Internal Medicine Recovery Clinic; 🇺🇸 Greenville, South Carolina, United States