CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: CBT4CBT-Buprenorphine + Recovery Coach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Treatment As Usual (TAU)<br>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. | |
| Experimental: CBT4CBT-Buprenorphine + Recovery Coach<br>This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional | Behavioral: CBT4CBT-Buprenorphine + Recovery Coach<br>* This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)<br>* Other names: CBT4CBT+ Recovery Coach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in drug use | Using saliva toxicology tests | 0-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention to buprenorphine | 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 | 3 month follow up | 
| Change in drug use | Using saliva toxicology tests | 1 and 3 month follow up |