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
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.
- 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