NCT07128485

Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Type 1 hybrid effectiveness-implementation randomized controlled trial, Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose, 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 fentanyl test strips on overdose outcomes, using a novel 2x2 design crossing fentanyl test strip distribution and education to determine which approach most significantly reduces overdose rates while minimizing costs. This research will inform scalability around mail-based fentanyl test strip distribution and education programs to address the nation's opioid overdose crisis.

Detailed description

This Type 1 hybrid effectiveness-implementation randomized controlled trial, Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids. Fentanyl test strips (FTS) are a cheap, low burden tool used to detect the presence of fentanyl in drugs, and they are associated with high acceptability, yet critical FTS knowledge and implementation gaps persist. Moreover, extant studies of FTS programs are either limited to one city or region and enroll from brick-and-mortar sites, with no remote randomized controlled trials (RCTs) to date. This study would be the first national, fully remote RCT to assess the impact of FTS on overdose outcomes among people using illicit stimulants and/or opioids. This project adapts the investigators' Remote Opioid Overdose Education and Naloxone Distribution intervention to FTS using a human-centered design approach, leveraging partnerships with national and regional community partners to co-create a fully remote intervention. The study will use a 2x2 design to cross remote FTS distribution with remote FTS education, thereby isolating the individual and combined effects of the two components. The R61 phase focuses on adapting and piloting the interventions with 100 participants, assessing feasibility, acceptability, and appropriateness. The R33 phase implements a fully powered trial to compare overdose outcomes (fatal and non-fatal) among 2,952 participants randomized to the four study arms, which include: FTS distribution and education, FTS education only, FTS distribution only, and a control group. All groups will receive a resource list for naloxone and FTS. The secondary outcome is FTS knowledge, while exploratory outcomes include behavioral strategies to reduce risk of overdose (including FTS-specific behaviors) and utilization of substance use services engagement and treatment. The study also incorporates ecological momentary assessment to offer insights into daily contextual factors influencing FTS use, as well as a cost-effectiveness analysis to determine the most cost-effective approach with most overdoses averted. The study's 2x2 design allows for a thorough examination of the interactions between FTS distribution and education, identifying the most effective and cost-efficient approach for reducing overdose rates. Overall, findings will inform the scalability of remote overdose prevention interventions. This work represents a sustainable, fully remote model that can be implemented nationwide, setting the stage for transformative advancements in overdose prevention.

Conditions

• Accidental Overdose of Opiate

Interventions

Type	Name	Description
OTHER	Fentanyl test strips	Fentanyl test strips (FTS) are small strips of paper that can detect the presence of fentanyl in illicit drugs.
BEHAVIORAL	Fentanyl test strip education	Developed in the R61 phase, the educational intervention will provide participants with knowledge about how to correctly use fentanyl strips.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-08-19
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States