An interventional study of Nicotine Level 1 (0mg/ml) and Nicotine Level 2 (36mg/ml) in Nicotine Dependence and E-cigarette Use, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Yale University · Not applicable, Interventional, and Other
This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.
The goal of this protocol is to investigate how sex differences in response to menthol and nicotine influence product preference and choice. In this proposal, participants will be exposed to menthol non-nicotine and nicotine containing e-cigarettes and product preference and choice will be examined in a paradigm where a menthol nicotine-containing e-cigarette is progressively more difficult to earn, and a menthol non-nicotine e-cigarette is available at a low, fixed cost. Additionally, it will be investigated how menthol e-cigarettes with and without nicotine impact reward, appeal, and sensory effects in an initial sampling session (secondary and exploratory outcomes).
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Exclusion Criteria:
Participants will sample and rate three menthol flavored e-cigarettes with varying levels of nicotine.
Other: Nicotine Level 1 (0mg/ml) · Other: Nicotine Level 2 (36mg/ml) · Other: Nicotine Level 3 (59mg/ml)
Participants will make choices between two menthol e-cigarettes with different levels of nicotine.
Other: Nicotine Level 1 (0mg/ml) · Other: Nicotine Level 2 (36mg/ml)
Menthol with be paired with 0mg/ml nicotine in an e-cigarette
Menthol with be paired with 36mg/ml nicotine in an e-cigarette
Menthol with be paired with 59mg/ml nicotine in an e-cigarette
Proportion of Choices
Differences in proportion of choices for the two menthol e-cigarette for males and females in the Lab 2 preference task
Time frame: For the 3 hour period of the Lab 2 preference task
Breakpoint
Difference in highest point of the progressive ratio schedule obtained between males and females
Time frame: During the 3 hour period of the Lab 2 preference task
Reward
Difference in scores (range: 0-100) of the Liking/Wanting Subscale of the Drug Effects Questionnaire
Time frame: Immediately (~2 minutes) after e-cigarette exposures in Lab 1
Plan to share: Yes — Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
Supporting information: Informed consent form
Access criteria: The de-identified data may be made available for research purposes after study publication by contacting the PI.
No publications or documents are linked to this record.
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