NCT04024059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.4 years

First QC Date

July 16, 2019

Results QC Date

January 8, 2025

Last Update Submit

March 6, 2025

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine

    12 weeks

Study Arms (3)

Buprenorphine Adherence and Opiate Abstinence

EXPERIMENTAL

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

Behavioral: Contingency Management for adherenceBehavioral: Contingency Management for abstinence

Buprenorphine Adherence Only

EXPERIMENTAL

Participants will receive financial incentives for buprenorphine use.

Behavioral: Contingency Management for adherence

Control

NO INTERVENTION

Participants will not receive any intervention.

Interventions

Contingency Management for adherenceBEHAVIORAL

Incentives contingent on buprenorphine adherence

Buprenorphine Adherence OnlyBuprenorphine Adherence and Opiate Abstinence
Contingency Management for abstinenceBEHAVIORAL

Incentives contingent on opiate abstinence

Buprenorphine Adherence and Opiate Abstinence

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Opioid use disorder
  • Enrolled in buprenorphine treatment

You may not qualify if:

  • Unwilling or unable to use a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Kenneth Silverman, Ph.D.
Organization
Johns Hopkins University School of Medicine
ksilverm@jhmi.edu
4436176051

Study Officials

  • Kenneth Silverman, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 18, 2019

Study Start

January 31, 2020

Primary Completion

June 30, 2023

Study Completion

July 1, 2024

Last Updated

March 12, 2025

Results First Posted

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)