CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Prisma Health-Upstate

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: CBT4CBT-Buprenorphine + Recovery Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT04824404

87691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Standard Treatment As Usual (TAU)

No Intervention group

Description:

Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly or bi-weekly visits (at the discretion of the provider) to the clinic to meet with their provider and provide a sample of blood.

CBT4CBT-Buprenorphine + Recovery Coach

Experimental group

Description:

This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional

Treatment:

Behavioral: CBT4CBT-Buprenorphine + Recovery Coach