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Fentanyl Test Strips for Drug Overdose
N/A
Recruiting
Led By Gary Smith, MD, DRPH
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up quarter 3 of year 3
Awards & highlights
Study Summary
This trialaims to explore how providing health education and contraception in courtrooms can benefit Ohio communities.
Who is the study for?
This trial is for adults over 18 in Ohio who use English, have contact info for follow-ups, are not in jail, and use illicit stimulants. They must be enrolled in specific Ohio drug courts or on probation with them.Check my eligibility
What is being tested?
The study tests if teaching about and giving out Fentanyl Test Strips (FTS) in certain Ohio courts can help prevent overdoses from drugs like opioids and fentanyl.See study design
What are the potential side effects?
Since the intervention involves education and distribution of test strips rather than a medical treatment, there are no direct side effects associated with its use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ quarter 3 of year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quarter 3 of year 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Follow-up questionnaire
Interview
Key informant interviews
+1 moreSide effects data
From 2009 Phase 4 trial • 237 Patients • NCT01795898100%
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. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period.
Group II: Non-Intervention ArmActive Control1 Intervention
Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. 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 3.
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,218,756 Total Patients Enrolled
Gary Smith, MD, DRPHPrincipal InvestigatorNationwide Children's Hospital, Center for Injury Research & Policy
1 Previous Clinical Trials
2,400 Total Patients Enrolled
Nichole Michaels, PhDPrincipal InvestigatorNationwide Children's Hospital, Center for Injury Research & Policy
1 Previous Clinical Trials
2,400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a phone or email for follow-ups.I am 18 years old or older.You have used illegal stimulants within the last 6 months and have reported it.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Intervention Arm
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial recruiting any additional participants?
"Affirmative. According to clinicaltrials.gov, this investigation is actively enrolling patients - it was initially posted on November 10th of 2022 and revised a day later. Additionally, 1750 participants are sought at 1 site for inclusion in the trial."
Answered by AI
What is the maximum sample size of this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study is still enlisting participants and was first posted on November 10th 2022. The latest update was recorded on the 11th of November in the same year; 1750 patients from 1 site need to be recruited for the trial."
Answered by AI
Who else is applying?
What site did they apply to?
Nationwide Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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