Sex Differences in E-Cigarette Perception
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotine Level 1 (0mg/ml), Nicotine Level 2 (36mg/ml), Nicotine Level 3 (59mg/ml).
- Who it may be relevant to
- Registry conditions: Nicotine Dependence, E-cigarette Use. Basic parameters: 21 years — 44 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sex Differences in E-Cigarette Perception: Study 2
Overview
This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.
Detailed description
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).
Interventions
- Other Nicotine Level 1 (0mg/ml)
Menthol with be paired with 0mg/ml nicotine in an e-cigarette - Other Nicotine Level 2 (36mg/ml)
Menthol with be paired with 36mg/ml nicotine in an e-cigarette - Other Nicotine Level 3 (59mg/ml)
Menthol with be paired with 59mg/ml nicotine in an e-cigarette
Primary outcome measures
- Proportion of Choices [Time frame: For the 3 hour period of the Lab 2 preference task]
- Breakpoint [Time frame: During the 3 hour period of the Lab 2 preference task]
Secondary outcome measures (1)
- Reward [Time frame: Immediately (~2 minutes) after e-cigarette exposures in Lab 1]
Eligibility criteria
Inclusion criteria
- Able to read/write in English
- Current cigarette smoking
- Prior e-cigarette exposure
- Biochemically verified cigarette use
- Not trying to quit tobacco use
Exclusion criteria
- Significant medical concerns that would increase study risk
- Use of psychoactive drugs unless prescribed and stable
- Allergy to menthol or other e-liquid ingredients
- Dislike of menthol
- Pregnant, trying to get pregnant, breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Yale School of Medicine — New Haven
Identifiers
NCT: NCT07398976 · 2000041248 · 5K01DA056494