CBT4CBT for Office Based Buprenorphine

Phase 1

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: CBT4CBT-Buprenorphine; Drug: Buprenorphine/naloxone

• Registration Number: NCT03580902
• Lead Sponsor: CBT4CBT, LLC

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-10
• Study Start: 2019-01-22
• Primary Completion: 2021-11-23
• Study Completion: 2022-08-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Buprenorphine plus CBT4CBT-Buprenorphine	Buprenorphine/naloxone	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.
Standard Buprenorphine plus CBT4CBT-Buprenorphine	CBT4CBT-Buprenorphine	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.
Standard Buprenorphine	Buprenorphine/naloxone	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.

Primary Outcome Measures

Name	Time	Method
Percent of urine toxicology screens that are negative for opioids by group.	12 weeks	Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.

Trial Locations

Locations (1)

Central Medical Unit of the APT Foundation; 🇺🇸 New Haven, Connecticut, United States