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
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

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