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Health Warning Labels for Vaping

N/A

Recruiting

Led By Wasim Maziak, MD, PhD

Research Sponsored by Florida International University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 21-35 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the 2 participant visits. blood will be taken 2 times in each ends use session: before and after an approximately 60-min ad lib use period

Awards & highlights

Study Summary

This trial will test the effect of different health warning labels on electronic nicotine delivery systems in young adults, measuring outcomes like satisfaction, dependence, and quitting intention.

Who is the study for?

This trial is for healthy young adults aged 21-35 who use electronic nicotine delivery systems (ENDS) daily or occasionally. Participants must have abstained from ENDS for 12 hours before sessions and be willing to attend lab visits. Excluded are those using other tobacco products, with chronic diseases, cardiovascular issues, high/low blood pressure, seizures, certain medication users, THC users, recent COVID-19 exposure or symptoms.Check my eligibility

What is being tested?

The study aims to develop pictorial health warning labels (HWLs) for ENDS devices and test their impact on user perceptions like satisfaction and harm awareness as well as objective measures such as nicotine levels in the blood and puffing patterns during vaping sessions.See study design

What are the potential side effects?

Since this trial involves observing behavior rather than testing a new drug or medical intervention, there are no direct side effects from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the 2 participant visits. blood will be taken 2 times in each ends use session: before and after an approximately 60-min ad lib use period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the 2 participant visits. blood will be taken 2 times in each ends use session: before and after an approximately 60-min ad lib use period

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 2 participant visits. blood will be taken 2 times in each ends use session: before and after an approximately 60-min ad lib use period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma nicotine

Secondary outcome measures

Carbon monoxide levels

Duke Sensory Questionnaire

Forced expiratory flow

+8 more

Other outcome measures

Blood pressure

Heart rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: Preferred ENDS with HWLExperimental Treatment2 Interventions

All participants will complete a lab visit where they will use their preferred ENDS with a HWL on the device ad libitum for up to 60 minutes

Group II: Preferred ENDSExperimental Treatment2 Interventions

All participants will complete a lab visit where they will use their preferred ENDS ad libitum for up to 60 minutes

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor

100 Previous Clinical Trials

17,345 Total Patients Enrolled

University of MiamiOTHER

901 Previous Clinical Trials

409,776 Total Patients Enrolled

1 Trials studying Vaping

90 Patients Enrolled for Vaping

Wasim Maziak, MD, PhDPrincipal InvestigatorFlorida International University

1 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

Preferred ENDS with HWL Clinical Trial Eligibility Overview. Trial Name: NCT04907136 — N/A

Vaping Research Study Groups: Preferred ENDS, Preferred ENDS with HWL

Vaping Clinical Trial 2023: Preferred ENDS with HWL Highlights & Side Effects. Trial Name: NCT04907136 — N/A

Preferred ENDS with HWL 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907136 — N/A

Frequently Asked Questions

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

Who qualifies for participation in this clinical investigation?

"This trial is in search of 210 young adults (ages 21 to 29) with a history of e-cigarette use. In addition, applicants must be physically healthy and have abstained from ENDS for at least 12 hours prior to each session."

Answered by AI

Is the recruitment process still open for participants of this experiment?

"According to the details provided on clinicaltrials.gov, this research trial is not currently recruiting participants. Initial posting was March 1st 2023 with a subsequent update of October 31st 2022; but 12 other trials are presently enrolling volunteers at this time."

Answered by AI

Is the minimum age requirement of this trial 65 years or younger?

"This clinical trial's inclusion criteria state that the desired participants are between 21 to 29 years old. Additionally, there is a separate study tailored for those under 18 and four trials specifically designed for individuals over 65."

Answered by AI

What potential drawbacks exist to utilizing Preferred ENDS with HWL?

"According to our internal assessment, Preferred ENDS with HWL is a safe treatment option and has been given a score of 3 in line with its Phase 4 status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Developing and Testing Health Warning Labels on the ENDS Device

Wasim Maziak, MD, PhD 2023. "Developing and Testing Health Warning Labels on the ENDS Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907136.