NCT07128485|Not Yet RecruitingDMC
Remote Intervention to Prevent Overdose
A Remote Intervention to Prevent Overdose Among People Who Use Stimulants and/or Opioids
Loading search results
A Remote Intervention to Prevent Overdose Among People Who Use Stimulants and/or Opioids
Sponsor study identifier
Secondary identifiers
interventional
100
1 country
2
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This Type 1 hybrid effectiveness-implementation randomized controlled trial, A Remote Intervention to Prevent Overdose among People who Use Stimulants and/or Opioids, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids by reducing overdose rates. It is supported by and included in the HEAL Initiative. This study would be the first national, fully remote trial to assess the impact of remote education on overdose outcomes, using a novel 2x2 design crossing remote education with remote access support. This research will inform scalability around remote education programs to address the nation's opioid overdose crisis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 13, 2025
Actual (reported)August 19, 2025
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overdose
Includes both self-reported non-fatal overdose and fatal overdose
Baseline, 1 month, 3 months, 6 months
Overdose prevention knowledge
Baseline, 1 month, 3 months, 6 months
This arm receives both overdose prevention education and access to overdose prevention resources.
The Education only arm receives overdose prevention education.
Overdose prevention resources (e.g., naloxone) are resources used to prevent drug overdose.
Developed in the R61 phase, the educational intervention will provide participants with knowledge about how prevent drug overdose.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
First Submitted
August 13, 2025
First Posted
August 19, 2025
Study Start
January 2027
EstimatedThis arm receives access to overdose prevention resources.
The referral only arm receives a resource list for obtaining naloxone and other overdose prevention resources on their own.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
The study team will share de-identified individual participant data (IPD) underlying the results reported in publications arising from this trial. Shared IPD will include participant-level data on demographics, overdose prevention knowledge and self-efficacy, perceived overdose risk, overdose history, substance use service engagement, protective behavior strategies, screening survey responses, and ecological momentary assessment (EMA) data. All shared datasets will be stripped of direct identifiers and other information that could reasonably be used to identify participants. Aggregate recruitment and retention data will also be made publicly available. Data sharing will comply with applicable federal regulations, institutional policies, and participant confidentiality protections.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: