Contingency Management to Enhance Office-Based Buprenorphine Treatment

Opioid-use Disorder Clinical Trial

Official title:

Contingency Management to Enhance Office-Based Buprenorphine Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04024059
• Other study ID #: IRB00220692
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 375
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Opioid use disorder

• Enrolled in buprenorphine treatment

Exclusion Criteria:

• Unwilling or unable to use a smartphone

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Contingency Management for adherence
Incentives contingent on buprenorphine adherence
• Contingency Management for abstinence
Incentives contingent on opiate abstinence

Locations

Country	Name	City	State
United States	Center for Learning and Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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