Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

NCT ID: NCT05288751

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2026-08-31

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.

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.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.

Interventions

Contingency Management

Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Levy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

FMCH-2022-30581

Identifier Type: -

Identifier Source: org_study_id