Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

NCT05288751 | Active Not Recruiting

• 1 other identifier: FMCH-2022-30581
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

opioid use disorder; stimulant use disorder; contingency management; primary care; addiction medicine; buprenorphine

Outcome Measures

Primary Outcomes (4)

• Preliminary efficacy of CM on clinical outcomes: Visit Frequency

  Number of completed clinical visits per patient during the CM program.

  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.

  30 days post-intervention

• Feasibility of CM for OUD in primary care: Recruitment

  percentage of patients invited to participate enroll in the treatment intervention.

  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.

  30 days post-intervention

Study Arms (3)

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.

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.

Behavioral: Contingency Management

Interventions

Contingency Management BEHAVIORAL

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

Attendance + abstinence CM; Attendance-only CM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert Levy, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (1)