Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose

NCT07128485 | Not Yet Recruiting DMC

• 2 other identifiers: IRB 3000150531R61DA065247-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Accidental Overdose of Opiate

Keywords

overdose prevention; fentanyl test strips; fentanyl; opioid use disorder; stimulant use disorder; accidental overdose

Outcome Measures

Primary Outcomes (1)

• Overdose

  Includes both self-reported non-fatal overdose and fatal overdose as reported by the National Death Index.

  Baseline, 1 month, 3 months, 6 months

Secondary Outcomes (1)

• Fentanyl test strip knowledge

  Baseline, 1 month, 3 months, 6 months

Other Outcomes (6)

• Protective Behavioral Strategies

  Baseline, 1 month, 3 months, 6 months

• Types of drugs tested with fentanyl test strips

  Baseline, 1 month, 3 months, 6 months

• Number of fentanyl test strips used

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

Study Arms (4)

FDE

EXPERIMENTAL

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.

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

E

EXPERIMENTAL

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

Behavioral: Fentanyl test strip education

FD

EXPERIMENTAL

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.

Other: Fentanyl test strips

R

NO INTERVENTION

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

Interventions

Fentanyl test strips OTHER

Fentanyl test strips (FTS) are small strips of paper that can detect the presence of fentanyl in illicit drugs.

FD; FDE

Fentanyl test strip education BEHAVIORAL

Developed in the R61 phase, the educational intervention will provide participants with knowledge about how to correctly use fentanyl strips.

E; FDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Emma S Kay, PhD, MSW

CONTACT

205-996-5547; emmakay@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Using a 2x2 design, there will be four study arms. All arms will be given a resource list on where to obtain naloxone and fentanyl test strips (FTS), while other arms will additionally receive mail-distributed FTS, FTS education, or both. These 4 groups include: FTS distribution + education (FDE), FTS education (E), FTS distribution only (FD), and a control group (referral only).

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)