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

No Placebo-Only Group

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).

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.

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 weeks3 visits

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

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.