Contingency Management to Enhance Office-Based Buprenorphine Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Contingency Management for adherence; Behavioral: Contingency Management for abstinence

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.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jackie Hampton; Phone Number: 1-866-857-9851; Email: jhampton@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Center for Learning and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Opioid use disorder
• Enrolled in buprenorphine treatment

Exclusion Criteria:

• Unwilling or unable to use a smartphone

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Kenneth Silverman, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB00220692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No