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Fentanyl Test Strips for Preventing Opioid Overdose

N/A
Recruiting
Led By Nichole Michaels, PhD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up quarter 3 of year 5
Awards & highlights

Study Summary

This trial will test whether providing information about and access to the opioid reversal medication naloxone to people who use drugs reduces overdose deaths.

Who is the study for?
This trial is for adults over 18 in Ohio who use street-bought drugs or prescriptions and can be contacted by phone or email. They must understand English and visit a Project DAWN site that's part of the study.Check my eligibility
What is being tested?
The study is testing if teaching people how to use Fentanyl Test Strips (FTS) at certain Project DAWN sites helps prevent overdoses in both rural and urban areas.See study design
What are the potential side effects?
There are no direct medical side effects from participating, as the intervention involves education on using FTS to detect fentanyl in drugs, which could reduce overdose risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quarter 3 of year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and quarter 3 of year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.
Opioids

Side effects data

From 2009 Phase 4 trial • 237 Patients • NCT01795898
100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Insomnia
2%
Headache
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Each participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period.
Group II: Non-Intervention ArmActive Control1 Intervention
Fentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 5.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,218,103 Total Patients Enrolled
Nichole Michaels, PhDPrincipal InvestigatorNationwide Children's Hospital, Center for Injury Research & Policy
1 Previous Clinical Trials
1,750 Total Patients Enrolled
Gary Smith, MD, DRPHPrincipal InvestigatorNationwide Children's Hospital, Center for Injury Research & Policy
1 Previous Clinical Trials
1,750 Total Patients Enrolled

Media Library

Fentanyl Test Strips (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05463341 — N/A
Fentanyl Test Strips (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463341 — N/A
Opioid Overdose Research Study Groups: Intervention Arm, Non-Intervention Arm
Opioid Overdose Clinical Trial 2023: Fentanyl Test Strips Highlights & Side Effects. Trial Name: NCT05463341 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the process for enrolling participants in this experiment?

"The details on clinicaltrials.gov demonstrate that this trial is still recruiting candidates with the latest update occurring on September 14th, 2022; it was initially posted nine days prior to that, on September 9th."

Answered by AI

What is the cap on participation in this research?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this research is currently recruiting participants, with 2400 people needed from 1 centre. This trial was initially posted September 9th 2022 and recently modified on the 14th of September 2022."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~327 spots leftby Jul 2024