- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05288751
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
September 4, 2025 updated by: University of Minnesota
Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting
Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.
When applied to the treatment of substance use disorders, it has demonstrated efficacy in reducing the number of urine toxicology screens positive for illicit substances and increased engagement in treatment programs.
However, there is a need to translate CM treatment to primary care settings.
This study will implement and assess a CM program for patients with opioid use disorder, with or without comorbid stimulant use disorder, initiating outpatient addiction medicine services at a family medicine residency clinic.
Eligible patients will earn monetary incentives for attending addiction medicine appointments and abstaining from substances during outpatient treatment.
Data gathered from this pilot program will be used to improve patient outcomes, treatment, and retention for persons receiving medications for opioid use disorder (MOUDs) in a primary care setting.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- At least 18 years of age
- Diagnosis of Opioid Use Disorder and/or Stimulant Use Disorder
- Recently initiated medications for opioid use disorder (MOUDs) at Broadway Family Medicine (BFM), within 2 weeks of recruitment
- Have an active prescription for buprenorphine-naloxone (Suboxone)
Exclusion Criteria:
- Prescription for an amphetamine would exclude patients from the abstinence-based CM, but they could participate in the attendance-only CM.
- Dementia, development disabilities, or cognitive functioning that is too low to participate in study measures, as determined by chart review and consultation with overseeing physician.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as usual (TAU)
These patients will not be assigned to the CM programs, but will be invited to complete study measures at the same time points: baseline, 3-months, 6-months, and 12-months.
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Experimental: Attendance-only CM
Patients in this arm complete an appointments with his or her primary care provider (PCP) or member of the PCP's microteam .
These appointments must be initiated by the PCP/microteam in accordance with the patient's treatment plan for regular follow-up appointments.
|
Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.
|
|
Experimental: Attendance + abstinence CM
Patients who test stimulant-positive during the initial urine drug screen (UDS) at their intake visit will be invited to additionally enroll in the abstinence CM schedule.
All of the attendance-only CM rules described previously will apply to patients in the attendance + abstinence program.
|
Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary efficacy of CM on clinical outcomes: Visit Frequency
Time Frame: 30 days post-intervention
|
Number of completed clinical visits per patient during the CM program.
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30 days post-intervention
|
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Preliminary efficacy of CM on clinical outcomes: Urine toxicology
Time Frame: 30 days post-intervention
|
Percentage of UDS results that are negative for stimulants during the CM intervention period.
|
30 days post-intervention
|
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Feasibility of CM for OUD in primary care: Recruitment
Time Frame: 30 days post-intervention
|
percentage of patients invited to participate enroll in the treatment intervention.
|
30 days post-intervention
|
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Feasibility of CM for OUD in primary care: Retention
Time Frame: 30 days post-intervention
|
Of those patients who enroll in the intervention study, the percent that complete the CM intervention period.
|
30 days post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Levy, MD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 21, 2022
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 4, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMCH-2022-30581
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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