Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05973838

Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Polysubstance Addiction Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Narcotic-Related Disorders Opioid Medication Assisted Treatment Opioid-Related Disorders Retention in Care Substance-Related Disorders Treatment Adherence Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIPS Clinic, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers.

This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=160) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Six-month OUD Treatment Retention

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

    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.

  2. Six-month Buprenorphine Adherence

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

    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.

  3. Six-month Self-Report Buprenorphine Adherence

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

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

  4. Six-Month Problems Associated with Substance Use

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

    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.

  5. Intervention Uptake

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

    Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention.

  6. Intervention Session Attendance

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

    Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured.

  7. Intervention Fidelity

    Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)

    Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured.

Other outcomes

  1. Three-month OUD Treatment Retention

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

    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.

  2. Three-Month Polysubstance Use Urinalysis

    Time frame: Measured from baseline to 3-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.

  3. Three-Month Polysubstance Use Self Report

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

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

  4. Three-Month Problems Associated with Substance Use

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

    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.

  5. Three-month Buprenorphine Adherence

    Time frame: Measured over 3 months

    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 3 months will be assessed and calculated via the percent retained on MT for at least 3 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 3 months.

  6. Three-month Self-Report Buprenorphine Adherence

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

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

  7. Twelve-month OUD Treatment Retention

    Time frame: Measured from intake through 12-month follow up

    Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at twelve months post MOUD initiation.

  8. Twelve-Month Polysubstance Use Urinalysis

    Time frame: Measured from baseline to 12-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.

  9. Twelve-Month Polysubstance Use Self Report

    Time frame: Measured from baseline to 12-month follow-up.

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

  10. Twelve-Month Problems Associated with Substance Use

    Time frame: Assessed between the baseline and 12-month follow-up.

    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.

  11. Twelve-month Buprenorphine Adherence

    Time frame: Measured over 12 months

    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 12 months will be assessed and calculated via the percent retained on MT for at least 12 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 12 months.

  12. Twelve-month Self-Report Buprenorphine Adherence

    Time frame: Assessed between the baseline assessment and 12-month follow-up

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

  13. Six-month Treatment Cost

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

    The resources required to implement and sustain the interventions (Peer Activate-MTU, and ETAU) will be identified via micro-costing techniques, using a tailored version of the Drug Abuse Treatment Cost Analysis Program (DATCAP) instrument, a standardized, customizable tool designed to capture intervention resources in multiple settings for the purpose of estimating costs.

  14. Six-month Healthcare Resource Utilization

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

    Healthcare Resource Utilization by participants will be self-reported using time-anchoring methodology via the Non-study Medical and Other Services (NMOS) form, and will include non-study MOUD care, inpatient, outpatient, and emergency department services; SUD treatment medications; residential and outpatient SUD treatment days; hospital SUD detoxification days; and mental health treatment.

  15. Six-month Health-related Quality of Life

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

    Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) instrument.

  16. Six-month Non-Medical and Other Resource Utilization

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

    Use of non-medical and other resources from the societal perspective (e.g., school/workplace productivity, travel time to care, caregiver burden, etc.) will also be self-reported using the NMOS.

  17. Six-month Criminal and Legal Activities

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

    Criminal and legal activities will be measured using the time-anchoring methodology via the Criminal-Legal Activities Form (CLAF).

  18. Overdose risk

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

    Overdose risk will be assessed as a binary outcome (including both fatal and non-fatal overdoses).

Study contacts

Contact information is provided by the study sponsor or research team.

Morgan S Anvari, BA

CONTACT

[email protected]

3014055095

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Maryland, Baltimore
  • Weill Medical College of Cornell University

Registry information

Official study title

Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area

Acronym: PRISM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.