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Completed

NCT Number: NCT04024059

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Learning and Health

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

Exclusion criteria

  • Unwilling or unable to use a smartphone

Treatment and study plan

contingency management for adherence

Behavioral

Incentives contingent on buprenorphine adherence

Contingency Management for abstinence

Behavioral

Incentives contingent on opiate abstinence

Primary outcomes

  1. 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.

  2. 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

  1. Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine

    Time frame: 12 weeks

    This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 18, 2019
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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