Contingency Management to Enhance Office-Based Buprenorphine Treatment

Not Applicable

Completed

Conditions: Opioid-use Disorder

Interventions: Behavioral: Contingency Management for adherence
Behavioral: Contingency Management for abstinence

Registration Number: NCT04024059

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 375

Inclusion Criteria

Opioid use disorder
Enrolled in buprenorphine treatment

Exclusion Criteria

Unwilling or unable to use a smartphone

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine Adherence Only	Contingency Management for adherence	Participants will receive financial incentives for buprenorphine use.
Buprenorphine Adherence and Opiate Abstinence	Contingency Management for abstinence	Participants will receive financial incentives for buprenorphine use and opiate abstinence.
Buprenorphine Adherence and Opiate Abstinence	Contingency Management for adherence	Participants will receive financial incentives for buprenorphine use and opiate abstinence.

Primary Outcome Measures

Name	Time	Method
Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples	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	12 weeks	This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.

Secondary Outcome Measures

Name	Time	Method
Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine	12 weeks	This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.