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Study identifier: NCT05338801 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effect of Menthol on ENDS Users' Addiction and Exposure

Condition: Electronic Cigarette Use  ·  Sponsor: Florida International University

PhaseNA
Planned participants250
Who can joinAll sexes, 21 Years to 35 Years
Healthy volunteersYes

About this study

The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS heat and vaporize a nicotine-containing liquid to produce an inhalable aerosol mist. While generally considered less harmful than combustible cigarettes, ENDS use exposes users to dependence-producing nicotine and respiratory and cardiovascular toxicants such as aldehydes. Flavor is a major factor in getting young people to use ENDS, thus limiting flavors to menthol and tobacco for prefilled cartridge ENDS "pod mods" was the first major action taken by the FDA to reduce the spread of ENDS among young people. Menthol flavor, however, can present a potential risk given its increasing popularity among young people in the US, and its puffing and nicotine-enhancing properties. Yet, the extent of menthol's ability to affect users' experience and puffing patterns, and how these affect dependence, exposure to toxicants, and clinical outcomes continue to be understudied. Such evidence will be critical to the FDA's ability to set further regulatory standards to reduce ENDS potential harm. The investigators will conduct a 2x2 (pre-post x menthol vs. tobacco flavor) crossover clinical lab study. The investigator will recruit current/past month ENDS users (n=250, 21-35 yrs), who will attend two sessions and use their ENDS once with menthol and once with tobacco flavors. The proposed studies will answer two key regulatory questions consistent w…

This description comes directly from the study's public registry record.

Talk to the study team

Wasim Maziak, PhD, MD  ·  3053484501  ·  wmaziak@fiu.edu

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Locations (1)

Florida International UniversityMiami, Florida, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05338801