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Contingency Management to Enhance Office-Based Buprenorphine Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024059
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : March 20, 2023
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Contingency Management for adherence Behavioral: Contingency Management for abstinence Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Contingency Management to Enhance Office-Based Buprenorphine Treatment
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Buprenorphine diversion as assessed by the rates at which participants report diverting participants' buprenorphine [ Time Frame: 12 weeks ]
    This will be assessed by the rates at which participants report diverting participants' buprenorphine during the 12-week intervention.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

Exclusion Criteria:

  • Unwilling or unable to use a smartphone
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024059


Locations
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United States, Maryland
Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04024059    
Other Study ID Numbers: IRB00220692
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders