Contingency Management to Enhance Office-Based Buprenorphine Treatment
Primary Purpose
Opioid-use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management for adherence
Contingency Management for abstinence
Sponsored by
About this trial
This is an interventional health services research trial for Opioid-use Disorder
Eligibility Criteria
Inclusion Criteria:
- Opioid use disorder
- Enrolled in buprenorphine treatment
Exclusion Criteria:
- Unwilling or unable to use a smartphone
Sites / Locations
- Center for Learning and Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Buprenorphine Adherence and Opiate Abstinence
Buprenorphine Adherence Only
Control
Arm Description
Participants will receive financial incentives for buprenorphine use and opiate abstinence.
Participants will receive financial incentives for buprenorphine use.
Participants will not receive any intervention.
Outcomes
Primary Outcome Measures
Buprenorphine adherence as assessed by the percentage of buprenorphine-positive urine samples
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
Opiate abstinence as assessed by the percentage of opiate-negative urine samples
This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
Secondary Outcome Measures
Buprenorphine diversion as assessed by the rates at which participants report diverting participants' buprenorphine
This will be assessed by the rates at which participants report diverting participants' buprenorphine during the 12-week intervention.
Full Information
NCT ID
NCT04024059
First Posted
July 16, 2019
Last Updated
July 20, 2023
Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04024059
Brief Title
Contingency Management to Enhance Office-Based Buprenorphine Treatment
Official Title
Contingency Management to Enhance Office-Based Buprenorphine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period.
Detailed Description
Opioid use has increased to epidemic levels in the United States and has been associated with a dramatic increase in overdose deaths. Buprenorphine is a safe, well-tolerated, and evidence-based medication for opioid use disorder that can be prescribed in office-based treatment settings. Office-based buprenorphine could be an effective way to expand treatment for opioid use disorder, and thereby combat the opioid epidemic. However, office-based buprenorphine has three limitations that must be addressed to facilitate the safe and effective expansion of buprenorphine treatment: 1) Many patients discontinue buprenorphine treatment prematurely, 2) some patients divert buprenorphine for illicit use, and 3) many patients continue to use illicit opioids during buprenorphine treatment. This project will address these limitations by using a psychosocial approach known as Contingency Management. Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period. If the proposed intervention is effective, it could encourage medical professionals to prescribe buprenorphine, and improve patients' access to and success in office-based buprenorphine treatment.
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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine Adherence and Opiate Abstinence
Arm Type
Experimental
Arm Description
Participants will receive financial incentives for buprenorphine use and opiate abstinence.
Arm Title
Buprenorphine Adherence Only
Arm Type
Experimental
Arm Description
Participants will receive financial incentives for buprenorphine use.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management for adherence
Intervention Description
Incentives contingent on buprenorphine adherence
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management for abstinence
Intervention Description
Incentives contingent on opiate abstinence
Primary Outcome Measure Information:
Title
Buprenorphine adherence as assessed by the percentage of buprenorphine-positive urine samples
Description
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
Time Frame
12 weeks
Title
Opiate abstinence as assessed by the percentage of opiate-negative urine samples
Description
This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Buprenorphine diversion as assessed by the rates at which participants report diverting participants' buprenorphine
Description
This will be assessed by the rates at which participants report diverting participants' buprenorphine during the 12-week intervention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Opioid use disorder
Enrolled in buprenorphine treatment
Exclusion Criteria:
Unwilling or unable to use a smartphone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contingency Management to Enhance Office-Based Buprenorphine Treatment
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