An interventional study of Opioid Overdose Prevention Training in Remote vs. In-Person, Remote Visits and In-person Visits, sponsored by State University of New York at Buffalo. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Other
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.
State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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.
Common to all 3 RCTs:
Specific to RCT 3:
e) Meet criteria for Opioid Use Disorder and/or Stimulant Use Disorder (moderate or severe) on the DSM-5 Checklist and who report using either non-prescribed opioids (e.g., heroin, opioid pills) or stimulants (e.g., cocaine, methamphetamine) at least once in the past 3 months.
EXCLUSION CRITERIA:
Common to All 3 RCTs:
unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations
Specific to RCT3:
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
Behavioral: Opioid Overdose Prevention Training
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
Behavioral: Opioid Overdose Prevention Training
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
Behavioral: Opioid Overdose Prevention Training
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
Behavioral: Opioid Overdose Prevention Training
All participants receive a brief training video for the use of naloxone for opioid overdose prevention and a naloxone kit.
Accrual efficiency/Pre-treatment visits
Calculated from visit milestones. Percentage of screen-eligible participants who attend the Intake Visit after randomization to Remote vs In-Person Intake. Additional accrual metrics include 1) Intake-to-Treatment/Assessment Visit 1 completion and 2) Overall pre-treatment accrual (Brief Screen to Treatment/Assessment Visit 1.
Time frame: ~1 month
Trial Quality: Retention
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Time frame: ~3 months
Trial Quality: Treatment utilization (patient-reported)
At each of T/A Visits 2-5, we will assess via participant report the number of days (out of the past 7) that the participant had access to their naloxone and convert this to a percentage.
Time frame: ~ 3 months (from T/A Visit 2 to T/A Visit 5)
Trial quality: Biospecimen completion rates
The number of visits (0-5) for which a urine drug screen is completed during the Treatment/Assessment visits that each participant attended.
Time frame: ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
Plan to share: Yes — We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".
Supporting information: Study protocol, Informed consent form
Time frame: The study protocol and informed consent form will be shared at risetrials.org by 12/31/26. Consistent with NIH and Institute of Medicine recommendations, the data will be deposited no later than the publication of the primary study data or one year after each RCTs completion, whichever comes first. There is no planned end date.
Access criteria: The study protocol and informed consent form will be shared at risetrials.org by 12/31/26. Data submitted for archiving/sharing will be consistent with Inter-university Consortium for Political and Social Research (ICPSR) and the National Addiction and HIV Data Archive Program (NAHDAP) data standards and data stewardship policies and will contain no personal identifiers. Typically, the data are publicly available via a unique digital object identifier (DOI).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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