Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose

The University of Alabama at Birmingham

Status: Begins enrollment in 6 months

Conditions: Accidental Overdose of Opiate

Treatments: Other: Fentanyl test strips; Behavioral: Fentanyl test strip education

Study type: Interventional

Funder types: Other

Identifiers

NCT07128485

IRB 300015053

Details and patient eligibility

About

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. 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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

FDE

Experimental group

Description:

This arm receives both FTS distribution (FTS delivered to their residential address) and education (FDE), as well as a resource list for naloxone and additional FTS if desired.

Treatment:

Behavioral: Fentanyl test strip education

Other: Fentanyl test strips

E

Experimental group

Description:

The Education only (E) arm receives FTS education as well as a resource list for obtaining naloxone and FTS.

Treatment:

Behavioral: Fentanyl test strip education

FD

Experimental group

Description:

The FTS distribution only (FDE) arm receives FTS delivered to their residential address as well as a resource list for obtaining naloxone and additional FTS, if desired.

Treatment:

Other: Fentanyl test strips

R

No Intervention group

Description:

The referral only (R) arm receives a resource list for obtaining naloxone and FTS.