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Menthol-Flavored E-Cigarettes for Vaping

N/A
Recruiting
Led By Wasim Maziak, PhD, MD
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.
Age of 21-35 years
Must not have
Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year
Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 2 participant visits. blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Awards & highlights

Summary

This trial will study the effects of mentholated e-cigarettes compared to tobacco-flavored e-cigarettes in order to help the FDA assess the risks of mentholated e-cigarettes.

Who is the study for?
This trial is for healthy adults aged 21-35 who use e-cigarettes at least occasionally in the past month. Participants must not be pregnant, breastfeeding, or using other tobacco products regularly. They should have no chronic diseases, psychiatric conditions, cardiovascular issues, or regular medication use (except vitamins/birth control).Check my eligibility
What is being tested?
The study examines if menthol flavor in e-cigarettes affects addiction and exposure to toxicants more than tobacco flavor. It's a crossover study where participants will try both flavors during separate sessions and researchers will measure their puffing patterns and clinical responses.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, generally vaping can lead to throat irritation, coughing, dry mouth or eyes, headache and potential nicotine dependence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 35 years old.
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I am between 21 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used tobacco or nicotine products like e-cigarettes in the last year.
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I am not pregnant or breastfeeding.
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I am currently experiencing symptoms like cough, fever, or chest pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 2 participant visits. blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes 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 e-cigarette use session: before and after an approximately 60 minutes 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
Aldehydes (concentration) using smoking robot
Carbon monoxide levels
Duke Sensory Questionnaire
+12 more
Other outcome measures
Diastolic blood pressure
Heart rate
Systolic blood pressure

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tobacco-flavored e-cigaretteExperimental Treatment1 Intervention
All participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes.
Group II: Menthol-flavored e-cigaretteExperimental Treatment1 Intervention
All participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,305 Total Patients Enrolled
Wasim Maziak, PhD, MDPrincipal InvestigatorFlorida International University
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Menthol-flavored e-cigarette (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05338801 — N/A
Vaping Research Study Groups: Menthol-flavored e-cigarette, Tobacco-flavored e-cigarette
Vaping Clinical Trial 2023: Menthol-flavored e-cigarette Highlights & Side Effects. Trial Name: NCT05338801 — N/A
Menthol-flavored e-cigarette (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338801 — N/A
Vaping Patient Testimony for trial: Trial Name: NCT05338801 — N/A
~140 spots leftby Mar 2027