- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05700994
Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)
March 25, 2024 updated by: P. Todd Korthuis, MD, Oregon Health and Science University
The main goal of this study is to tests the effect of incentivizing achievement of self-identified, personal harm reduction goals (Contingency management or CM) compared with standard of care (peer harm reduction service with incentives for peer visits) to increase the reach and effectiveness of methamphetamine (MA) harm reduction services.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design, this study will randomize eighteen community-based peer harm reduction sites to provide contingency management incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g.
completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals) versus standard of care contingency management (i.e.
incentives for peer encounter attendance).
Study Type
Interventional
Enrollment (Estimated)
1800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Todd Korthuis, MD, MPH
- Phone Number: 503494-8044
- Email: korthuis@ohsu.edu
Study Contact Backup
- Name: Sara McCrimmon, MPH
- Email: mccrimmo@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Todd Korthuis
- Email: korthuis@ohsu.edu
-
Portland, Oregon, United States, 97232
- Recruiting
- Comagine Health
-
Contact:
- Erin Stack
- Email: estack@comagine.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 105 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
This intervention is at the site level. Community-based organization sites are eligible if they:
- Use peer support specialists to provide direct outreach and harm reduction services to people who use drugs
- Are willing to be trained in the two strategies for peer-facilitated contingency management
De-identified administrative data is used to identify an analytic sample of clients who:
• Reported past 30-day methamphetamine use at community-based organization intake.
Exclusion Criteria:
Community-based organization sites who:
- Do not use peer support specialists to provide direct outreach and harm reduction services to people who use drugs
- Are not willing to be trained in the two strategies for peer-facilitated contingency management
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEER-CM
Peer-facilitated contingency management (PEER-CM).
|
Participants allocated to peer-facilitated contingency management will receive incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g.
completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals)
Other Names:
|
Active Comparator: Standard of Care
Standard of care contingency management.
|
Participants allocated to standard of care contingency management will receive incentives for peer encounters.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who overdose
Time Frame: 6 months from baseline
|
Test the impact of incentives for achieving self-identified, personal harm reduction goals on the likelihood of overdose among people using methamphetamine at 6 months from enrollment identified through completed assessment.
|
6 months from baseline
|
Number of participants who achieve self-identified goals
Time Frame: 6 months from baseline
|
Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with harm reduction services at 6 months from enrollment identified through completed assessment.
|
6 months from baseline
|
Number of participants who engage in substance use disorder treatment
Time Frame: 6 months from baseline
|
Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with treatment services at 6 months from enrollment identified through completed assessment.
|
6 months from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2023
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
January 17, 2023
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Actual)
January 26, 2023
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- PEER-CM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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