CBT4CBT for Office Based Buprenorphine

A Method to Increase Buprenorphine Treatment Capacity

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03580902

Enrollment

Registered

2018-07-10

Start date

2019-01-22

Completion date

2022-08-01

Last updated

2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder

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.

Interventions

BEHAVIORALCBT4CBT-Buprenorphine

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

DRUGBuprenorphine/naloxone

Standard outpatient buprenorphine maintenance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026