Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, College Park

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Peer-Delivered Behavioral Activation ("Peer Activate")

    Behavioral

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Peer-Delivered Behavioral Activation ("Peer Activate")Experimental treatment 1 intervention
Group B: Treatment As UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured from baseline to 6-month follow-up
2

Six-Month Polysubstance Use Self Report

The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.

Time frame
Assessed between the baseline assessment 6-month follow-up

Secondary outcomes

1

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.

Time frame
Measured from intake through 6-month follow up
2

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.

Time frame
Measured from intake to six-month follow-up
3

Six-month Self-Report Buprenorphine Adherence

The IRA Wilson will be utilized to assess self-report buprenorphine adherence

Time frame
Assessed between the baseline assessment and 6-month follow-up
4

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.

Time frame
Assessed between the baseline assessment and 6-month follow-up

Other outcomes

1

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.

Time frame
Measured from intake through 3-month follow up
2

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.

Time frame
Measured from baseline to 3-month follow-up.
3

Three-Month Polysubstance Use Self Report

The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.

Time frame
Measured from baseline to 3-month follow-up.
4

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.

Time frame
Assessed between baseline assessment and 3-month follow-up.

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