CBT4CBT for Office Based Buprenorphine

January 2, 2023 updated by: CBT4CBT, LLC

A Method to Increase Buprenorphine Treatment Capacity

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511-5991
        • Central Medical Unit of the APT Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Buprenorphine/naloxone
Standard outpatient buprenorphine maintenance
Experimental: 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.
Drug: Buprenorphine/naloxone
Standard outpatient buprenorphine maintenance
Behavioral: CBT4CBT-Buprenorphine
Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of urine toxicology screens that are negative for opioids by group.
Time Frame: 12 weeks
Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CBT4CBT, LLC

Investigators

  • Principal Investigator: Julia Shi, MD, APT Foundation, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2019

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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