Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

Opioid Use Disorder Clinical Trial

Official title:

Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05288751
• Other study ID #: FMCH-2022-30581
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: May 29, 2024

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: May 29, 2024
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Stimulant Use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary efficacy of CM on clinical outcomes: Visit Frequency	Number of completed clinical visits per patient during the CM program.	30 days post-intervention
Primary	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
Primary	Feasibility of CM for OUD in primary care: Recruitment	percentage of patients invited to participate enroll in the treatment intervention.	30 days post-intervention
Primary	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