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Clinical Trials/NCT04024059
NCT04024059
Completed
Not Applicable

Contingency Management to Enhance Office-Based Buprenorphine Treatment

Johns Hopkins University1 site in 1 country375 target enrollmentJanuary 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
Johns Hopkins University
Enrollment
375
Locations
1
Primary Endpoint
Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2020
End Date
July 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

Exclusion Criteria

  • Unwilling or unable to use a smartphone

Outcomes

Primary Outcomes

Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples

Time Frame: 12 weeks

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

Time Frame: 12 weeks

This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.

Secondary Outcomes

  • Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine(12 weeks)

Study Sites (1)

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