Clinical trial

A Method to Increase Buprenorphine Treatment Capacity

Name

41941

Description

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).

Trial arms

Trial start

2019-01-22

Estimated PCD

2021-11-23

Trial end

2022-08-01

Status

Completed

Phase

Early phase I

Treatment

CBT4CBT-Buprenorphine

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

Arms:

Standard Buprenorphine plus CBT4CBT-Buprenorphine

Buprenorphine/naloxone

Standard outpatient buprenorphine maintenance

Arms:

Standard Buprenorphine, Standard Buprenorphine plus CBT4CBT-Buprenorphine

Size

Primary endpoint

Percent of urine toxicology screens that are negative for opioids by group.

12 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}

Updated at

2023-01-04

1 organization

1 product

1 indication

Organization

CBT4CBT

Product

Buprenorphine/naloxone

Indication

Opioid-use Disorder