CBT4CBT for Office Based Buprenorphine

Sponsor

CBT4CBT, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03580902

Collaborator

(none)

Enrollment

Location

Arms

41.4

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder	Behavioral: CBT4CBT-Buprenorphine Drug: Buprenorphine/naloxone	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Method to Increase Buprenorphine Treatment Capacity

Actual Study Start Date :

Jan 22, 2019

Actual Primary Completion Date :

Jul 5, 2022

Actual Study Completion Date :

Jul 5, 2022

Arms and Interventions

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.	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

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.

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Medical Unit of the APT Foundation	New Haven	Connecticut	United States	06511-5991

Sponsors and Collaborators

CBT4CBT, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CBT4CBT, LLC

ClinicalTrials.gov Identifier:

NCT03580902

Other Study ID Numbers:

41941

First Posted:

Jul 10, 2018

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Opioid-Related Disorders

Buprenorphine

Buprenorphine, Naloxone Drug Combination

Naloxone

Study Results

No Results Posted as of Jul 20, 2022