Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose

Not Applicable

Not yet recruiting

• Conditions: Accidental Overdose of Opiate

• Registration Number: NCT07128485
• Lead Sponsor: University of Alabama at Birmingham

Brief 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. Our 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. Our 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 our 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.

We 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2026-09-01
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years old
• English-speaking and reading
• Report using illicit opioids and/or stimulants (including counterfeit pills) within the past 3 months per the ASSIST
• Able and willing to provide informed consent
• Reside in any of the US states where fentanyl test strips are legal with no plans to move out of state for at least 12 months
• Reside in any of the US states where FTS are legal with no plans to move out of state for at least 12 months
• Be able and willing to provide the names and contact information of three close contacts to reach if the participant cannot be reached

Exclusion Criteria

• Living in a restricted environment (e.g., prison)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Overdose	Baseline, 1 month, 3 months, 6 months	Includes both self-reported non-fatal overdose and fatal overdose as reported by the National Death Index.

Secondary Outcome Measures

Name	Time	Method
Fentanyl test strip knowledge	Baseline, 1 month, 3 months, 6 months	Self-reported knowledge of how and when to use fentanyl test strips correctly, based on the fentanyl test strip education intervention developed in R61 phase

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States