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Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

NCT05463341 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2026-04-01

No results posted yet for this study

Summary

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select Project DAWN sites in rural and urban communities in Ohio.

Conditions

  • Opiate Overdose
  • Fentanyl Overdose
  • Harm Reduction

Interventions

BEHAVIORAL

Fentanyl Test Strips

A brief fentanyl test strip (FTS) education intervention will be given to participants at Project DAWN sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Nichole Michaels, PhD · Nationwide Children's Hospital, Center for Injury Research & Policy

  • Gary Smith, MD, DRPH · Nationwide Children's Hospital, Center for Injury Research & Policy

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2026-04-30
Completion
2026-04-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463341 on ClinicalTrials.gov