CBT4CBT for Office Based Buprenorphine

Study Overview
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Brief Summary
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In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).

Detailed Description
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In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.

Official Title
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A Method to Increase Buprenorphine Treatment Capacity

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: CBT4CBT-Buprenorphine
* Drug: Buprenorphine/naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation Exclusion Criteria: Unstabilized psychotic disorder Currently suicidal or homicidal Current cocaine, benzodiazepine, or alcohol use disorder. Any history of PCP (phencyclidine) use. Pregnant or lactating Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Buprenorphine<br>Participants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services. | Drug: Buprenorphine/naloxone<br>* Standard outpatient buprenorphine maintenance<br>|
| Experimental: Standard Buprenorphine plus CBT4CBT-Buprenorphine<br>Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills. | Behavioral: CBT4CBT-Buprenorphine<br>* Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment<br>Drug: Buprenorphine/naloxone<br>* Standard outpatient buprenorphine maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of urine toxicology screens that are negative for opioids by group. | Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites. | 12 weeks |