E-cigarette Use, Nicotine Dependence
Conditions
Keywords
Sex Differences, Females, E-cigarettes, Menthol, Nicotine, Vaping
Brief summary
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
OTHERNicotine Level 1 (0mg/ml)
Menthol with be paired with 0mg/ml nicotine in an e-cigarette
OTHERNicotine Level 2 (36mg/ml)
Menthol with be paired with 36mg/ml nicotine in an e-cigarette
OTHERNicotine Level 3 (59mg/ml)
Menthol with be paired with 59mg/ml nicotine in an e-cigarette
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants will test three e-cigarettes in containing varying levels of nicotine and menthol in a sampling session in Lab 1 in a double blinded randomized order. Investigator and research assistant (i.e., care provider) will know the nicotine concentrations and menthol level of the three e-cigarettes, but will be blinded to the order of presentation/participant. For Lab 2, two of the three e-cigarettes are compared in a choice task. The participant will not know the nicotine or menthol of the e-cigarettes (but as they will be labeled the same as Lab 1, so will have prior experience with them). The investigator and research assistant will know the e-cigarettes as a function of the study design.
Intervention model description
Study is a within subject design. All participants are exposed to the same three e-liquids in randomized order under double-blinded conditions in the Lab 1 sampling session. In Lab 2, two of the three e-liquids (the same two across participants) are tested in a concurrent choice session.
Eligibility
Sex/Gender
ALL
Age
21 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Choices | For the 3 hour period of the Lab 2 preference task | Differences in proportion of choices for the two menthol e-cigarette for males and females in the Lab 2 preference task |
| Breakpoint | During the 3 hour period of the Lab 2 preference task | Difference in highest point of the progressive ratio schedule obtained between males and females |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reward | Immediately (~2 minutes) after e-cigarette exposures in Lab 1 | Difference in scores (range: 0-100) of the Liking/Wanting Subscale of the Drug Effects Questionnaire |
Countries
United States
Contacts
CONTACTDanielle R Davis, PhD
PRINCIPAL_INVESTIGATORDanielle R Davis, PhD
Yale University
Outcome results
None listed