Opioid Use DisorderNCT05288751
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
A study testing Contingency Management in people with Opioid Use Disorder and Stimulant Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Stimulant Use Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Opioid Use Disorder, Stimulant Use Disorder
- Being tested
- Contingency Management
- Keywords
- opioid use disorder, stimulant use disorder, contingency management, primary care, addiction medicine, buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | 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. |
| Attendance-only CM | Experimental | 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. Receives: Behavioral: Contingency Management |
| Attendance + abstinence CM | Experimental | 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. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary efficacy of CM on clinical outcomes: Visit Frequency
Number of completed clinical visits per patient during the CM program.
Measured: 30 days post-intervention
Preliminary efficacy of CM on clinical outcomes: Urine toxicology
Percentage of UDS results that are negative for stimulants during the CM intervention period.
Measured: 30 days post-intervention
Feasibility of CM for OUD in primary care: Recruitment
percentage of patients invited to participate enroll in the treatment intervention.
Measured: 30 days post-intervention
Feasibility of CM for OUD in primary care: Retention
Of those patients who enroll in the intervention study, the percent that complete the CM intervention period.
Measured: 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Jun 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Levy, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288751
- Sponsor's protocol ID
- FMCH-2022-30581
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT05288751
- Acronym / sponsor ID
- FMCH-2022-30581
- Conditions
- Opioid Use Disorder, Stimulant Use Disorder
- Keywords
- opioid use disorder, stimulant use disorder, contingency management, primary care, addiction medicine, buprenorphine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –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. |
| Attendance-only CM | Experimental | Behavioral: Contingency ManagementPatients 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. |
| Attendance + abstinence CM | Experimental | Behavioral: Contingency ManagementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementContingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting. | Behavioural | Attendance + abstinence CM, Attendance-only CM |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Levy, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Opioid Use Disorder and Stimulant Use Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary efficacy of CM on clinical outcomes: Visit Frequency (time frame: 30 days post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.