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Contingency Management to Enhance Office-Based Buprenorphine Treatment

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Johns Hopkins University

Status

Completed

Conditions

Opioid-use Disorder

Treatments

Behavioral: Contingency Management for abstinence
Behavioral: Contingency Management for adherence

Study type

Interventional

Funder types

Other

Identifiers

NCT04024059
IRB00220692

Details and patient eligibility

About

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.

Full 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.

Enrollment

375 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

Exclusion criteria

  • Unwilling or unable to use a smartphone

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

375 participants in 3 patient groups

Buprenorphine Adherence and Opiate Abstinence
Experimental group
Description:
Participants will receive financial incentives for buprenorphine use and opiate abstinence.
Treatment:
Behavioral: Contingency Management for adherence
Behavioral: Contingency Management for abstinence
Buprenorphine Adherence Only
Experimental group
Description:
Participants will receive financial incentives for buprenorphine use.
Treatment:
Behavioral: Contingency Management for adherence
Control
No Intervention group
Description:
Participants will not receive any intervention.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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