Menthol E-Cigs under the microscope: do they boost nicotine and risk?
NCT ID NCT05338801
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how menthol flavor in e-cigarettes affects users' puffing habits, nicotine levels, and dependence compared to tobacco flavor. Researchers will have 250 young adults (ages 21-35) use both flavors in separate lab visits. The goal is to provide evidence for the FDA to decide if menthol-flavored e-cigarettes should be regulated to reduce harm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Menthol-flavored e-cigarette liquid
- What this could lead to
- If successful, this study could help the FDA decide whether to regulate menthol-flavored e-cigarettes to reduce harm among young users.
- What could go wrong
- This is an early-stage observational lab study, not a treatment trial. Results may not reflect real-world use or apply to all e-cigarette users.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Generally healthy individuals (determined by physical examination). * Age of 21-35 years. * Is willing to provide informed consent. * Is willing to attend the lab as required by the study protocol. * E-cigarette users (defined as using e-cigarette either daily or occasionally in the past 30 days) * Have abstained from e-cigarette use for 12 hours prior to each session Exclusion Criteria: * Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year). * 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). * Individuals with self-reported history of chronic disease or psychiatric conditions. * Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control). * Individuals that report current THC (marijuana) smoking/vaping. * Individuals that report current EVALI or COVID-19 related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss) * Individuals that have or have been exposed to COVID-19 in the last 14 days.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Florida International University
RECRUITINGMiami, Florida, 33199, United States
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