Contingency Management to Enhance Office-Based Buprenorphine Treatment

NCT ID: NCT04024059

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2024-07-01

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Buprenorphine Adherence and Opiate Abstinence

Participants will receive financial incentives for buprenorphine use and opiate abstinence.

Group Type: EXPERIMENTAL

Contingency Management for adherence

Intervention Type: BEHAVIORAL

Incentives contingent on buprenorphine adherence

Contingency Management for abstinence

Intervention Type: BEHAVIORAL

Incentives contingent on opiate abstinence

Buprenorphine Adherence Only

Participants will receive financial incentives for buprenorphine use.

Group Type: EXPERIMENTAL

Contingency Management for adherence

Intervention Type: BEHAVIORAL

Incentives contingent on buprenorphine adherence

Control

Participants will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Contingency Management for adherence

Incentives contingent on buprenorphine adherence

Intervention Type: BEHAVIORAL

Contingency Management for abstinence

Incentives contingent on opiate abstinence

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Opioid use disorder
• Enrolled in buprenorphine treatment

Exclusion Criteria

• Unwilling or unable to use a smartphone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Silverman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Center for Learning and Health

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00220692

Identifier Type: -

Identifier Source: org_study_id