An interventional study of Peer-Delivered Behavioral Activation ("Peer Activate") in Polysubstance Addiction, Opioid Medication Assisted Treatment and Treatment Adherence, sponsored by University of Maryland, College Park. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment
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.
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.
351 studies on the registry are indexed under Treatment Adherence and Compliance; 109 are open to participants now.
This study's planned enrollment of 160 is above the median of 82 across 271 interventional studies indexed under Treatment Adherence and Compliance.
Browse Treatment Adherence and Compliance studies →University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.
Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")
Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.
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.
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
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
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
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
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
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
Intervention Uptake
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.
Time frame: Assessed between the baseline assessment and 6-month follow-up
Intervention Session Attendance
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.
Time frame: Assessed between the baseline assessment 6-month follow-up
Intervention Fidelity
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.
Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
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
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.
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.
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.
Three-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 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.
Time frame: Measured over 3 months
Three-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 3-month follow-up
Twelve-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 twelve months post MOUD initiation.
Time frame: Measured from intake through 12-month follow up
Twelve-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 12-month follow-up.
Twelve-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 12-month follow-up.
Twelve-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 and 12-month follow-up.
Twelve-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 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.
Time frame: Measured over 12 months
Twelve-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 12-month follow-up
Six-month Treatment Cost
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.
Time frame: Measured from baseline to 6-month follow-up
Six-month Healthcare Resource Utilization
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.
Time frame: Measured from baseline to 6-month follow-up
Six-month Health-related Quality of Life
Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) instrument.
Time frame: Measured from baseline to 6-month follow-up
Six-month Non-Medical and Other Resource Utilization
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.
Time frame: Measured from baseline to 6-month follow-up
Six-month Criminal and Legal Activities
Criminal and legal activities will be measured using the time-anchoring methodology via the Criminal-Legal Activities Form (CLAF).
Time frame: Measured from baseline to 6-month follow-up
Overdose risk
Overdose risk will be assessed as a binary outcome (including both fatal and non-fatal overdoses).
Time frame: Measured from baseline to 6-month follow-up
Plan to share: Yes — After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Treatment Adherence and Compliance →
University of Maryland, College Park