Clinical trial Recruiting at 1 site Interventional Ages 21 to 35

Impact of Menthol on E-Cigarette Users' Addiction and Exposure

Official title: The Effect of Menthol on ENDS Users' Dependence, Respiratory, and Toxicants Emission Outcomes.

Run by Florida International University · NCT05338801 · Data updated 2026-11-12

This study is testing how menthol-flavored e-cigarettes affect addiction and exposure to harmful substances in young adults aged 21-35.

Quick facts

Study typeInterventional
Ages21 Years to 35 Years
SexAll
Enrollment250 (estimated)
SponsorFlorida International University
Academic / other
Locations1 site (Miami, Florida)
StatusRecruiting
StartedJune 22, 2022
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedApril 1, 2026
Trial IDNCT05338801 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are generally healthy e-cigarette users aged 21-35 who have abstained from e-cigarette use for 12 hours prior to each session.

Probably not a fit

Patients who smoke cigarettes regularly or use other tobacco products may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how menthol-flavored e-cigarettes affect addiction levels and exposure to harmful substances among users aged 21-35. It aims to understand the influence of menthol on puffing patterns and nicotine dependence, particularly in the context of rising e-cigarette use among young people. Participants will be required to abstain from e-cigarette use for 12 hours before each session, during which they will use either menthol or tobacco-flavored e-cigarettes. The findings could provide insights into the health implications of menthol in e-cigarettes and inform regulatory decisions.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and regulation of menthol-flavored e-cigarettes, potentially reducing addiction and health risks for users.

How similar studies have gone: While there is ongoing research into the effects of flavoring in tobacco products, the specific focus on menthol in e-cigarettes is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Florida International University
    Miami, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Wasim Maziak, PhD, MD — Florida International University
  • Study coordinator: Wasim Maziak, PhD, MD
  • Email: wmaziak@fiu.edu
  • Phone: 3053484501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Helping dual users of cigarettes and e-cigarettes quit smoking

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  • Testing health warning labels on e-cigarettes

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.