Contingency Management to Enhance Office-Based Buprenorphine Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contingency Management to Enhance Office-Based Buprenorphine Treatment

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Contingency Management for adherence
* Behavioral: Contingency Management for abstinence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Opioid use disorder Enrolled in buprenorphine treatment Exclusion Criteria: Unwilling or unable to use a smartphone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine Adherence and Opiate Abstinence<br>Participants will receive financial incentives for buprenorphine use and opiate abstinence. | Behavioral: Contingency Management for adherence<br>* Incentives contingent on buprenorphine adherence<br>Behavioral: Contingency Management for abstinence<br>* Incentives contingent on opiate abstinence<br>|
| Experimental: Buprenorphine Adherence Only<br>Participants will receive financial incentives for buprenorphine use. | Behavioral: Contingency Management for adherence<br>* Incentives contingent on buprenorphine adherence<br>|
| No Intervention: Control<br>Participants will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks |