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Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

Primary Purpose

Opioid Use Disorder, Stimulant Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring opioid use disorder, stimulant use disorder, contingency management, primary care, addiction medicine, buprenorphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Treatment as usual (TAU)

Attendance-only CM

Attendance + abstinence CM

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Preliminary efficacy of CM on clinical outcomes: Visit Frequency
Number of completed clinical visits per patient during the CM program.
Preliminary efficacy of CM on clinical outcomes: Urine toxicology
Percentage of UDS results that are negative for stimulants during the CM intervention period.
Feasibility of CM for OUD in primary care: Recruitment
percentage of patients invited to participate enroll in the treatment 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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2022
Last Updated
April 24, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05288751
Brief Title
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
Official Title
Contingency Management as a Treatment for Opioid Use Disorder and Stimulant Use Disorder in a Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
March 29, 2023 (Actual)
Study Completion Date
October 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Stimulant Use Disorder
Keywords
opioid use disorder, stimulant use disorder, contingency management, primary care, addiction medicine, buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Attendance-only CM
Arm Type
Experimental
Arm Description
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.
Arm Title
Attendance + abstinence CM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting.
Primary Outcome Measure Information:
Title
Preliminary efficacy of CM on clinical outcomes: Visit Frequency
Description
Number of completed clinical visits per patient during the CM program.
Time Frame
30 days post-intervention
Title
Preliminary efficacy of CM on clinical outcomes: Urine toxicology
Description
Percentage of UDS results that are negative for stimulants during the CM intervention period.
Time Frame
30 days post-intervention
Title
Feasibility of CM for OUD in primary care: Recruitment
Description
percentage of patients invited to participate enroll in the treatment intervention.
Time Frame
30 days post-intervention
Title
Feasibility of CM for OUD in primary care: Retention
Description
Of those patients who enroll in the intervention study, the percent that complete the CM intervention period.
Time Frame
30 days post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Levy, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

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