CBT4CBT for Office Based Buprenorphine

NCT ID: NCT03580902

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2022-08-01

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Buprenorphine

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.

Group Type: ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type: DRUG

Standard outpatient buprenorphine maintenance

Standard Buprenorphine plus 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.

Group Type: EXPERIMENTAL

CBT4CBT-Buprenorphine

Intervention Type: BEHAVIORAL

Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment

Buprenorphine/naloxone

Intervention Type: DRUG

Standard outpatient buprenorphine maintenance

Interventions

CBT4CBT-Buprenorphine

Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment

Intervention Type: BEHAVIORAL

Buprenorphine/naloxone

Standard outpatient buprenorphine maintenance

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CBT4CBT, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Shi, MD

Role: PRINCIPAL_INVESTIGATOR

APT Foundation, Inc.

Locations

Central Medical Unit of the APT Foundation

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

41941

Identifier Type: -

Identifier Source: org_study_id