NCT05973838 · University of Maryland, College Park
Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention
(PRISM)
What this study is about
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas.
View original scientific description
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.
Interventions
BEHAVIORAL
Peer-Delivered Behavioral Activation ("Peer Activate")
The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.
Primary outcome measures
Six-Month Polysubstance Use Urinalysis
Time frame: Measured from baseline to 6-month follow-up
Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
Six-Month Polysubstance Use Self Report
Time frame: Assessed between the baseline assessment 6-month follow-up
The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.
Exclusion criteria
- Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
- Inability to understand the study and provide informed consent in English
Where
- Washington D.C., District of Columbia
- Baltimore, Maryland
- College Park, Maryland
- Denton, Maryland
Collaborators
University of Maryland, Baltimore, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations