About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Peer-Delivered Behavioral Activation ("Peer Activate")
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Six-Month Polysubstance Use Urinalysis
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
The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
Secondary outcomes
Six-month OUD Treatment Retention
Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation.
Six-month Buprenorphine Adherence
Buprenorphine adherence will be assessed through 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. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months.
Six-month Self-Report Buprenorphine Adherence
The IRA Wilson will be utilized to assess self-report buprenorphine adherence
Six-Month Problems Associated with Substance Use
Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
Other outcomes
Three-month OUD Treatment Retention
Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at three months post MOUD initiation.
Three-Month Polysubstance Use Urinalysis
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.
Three-Month Polysubstance Use Self Report
The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
Three-Month Problems Associated with Substance Use
Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
Sponsors and contacts
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University of Maryland, College Park
Lead sponsor
University of Maryland, Baltimore
Collaborator
Weill Medical College of Cornell University
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator