Back to resultsCBT4CBT for Office Based Buprenorphine
Primary Purpose
Opioid-use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT4CBT-Buprenorphine
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
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.
Sites / Locations
- Central Medical Unit of the APT Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Buprenorphine
Standard Buprenorphine plus CBT4CBT-Buprenorphine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03580902
Brief Title
CBT4CBT for Office Based Buprenorphine
Official Title
A Method to Increase Buprenorphine Treatment Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CBT4CBT, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Buprenorphine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Buprenorphine plus CBT4CBT-Buprenorphine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT-Buprenorphine
Intervention Description
Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Intervention Description
Standard outpatient buprenorphine maintenance
Primary Outcome Measure Information:
Title
Percent of urine toxicology screens that are negative for opioids by group.
Description
Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.
Time Frame
12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Shi, MD
Organizational Affiliation
APT Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Medical Unit of the APT Foundation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511-5991
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CBT4CBT for Office Based Buprenorphine
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