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NCT03580902 Clinical Trial

CBT4CBT for Office Based Buprenorphine

Opioid-use Disorder Clinical Trial

Official title:
A Method to Increase Buprenorphine Treatment Capacity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03580902
Other study ID # 41941
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 22, 2019
Est. completion date August 1, 2022

Study information
Verified date January 2023
Source CBT4CBT, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date August 1, 2022
Est. primary completion date November 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• CBT4CBT-Buprenorphine
Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment
Drug:
• Buprenorphine/naloxone
Standard outpatient buprenorphine maintenance

Locations
Country Name City State
United States Central Medical Unit of the APT Foundation New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
CBT4CBT, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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