Purpose

This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 44 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
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.
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, 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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sampling Session - Lab 1
Participants will sample and rate three menthol flavored e-cigarettes with varying levels of nicotine.
  • 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
Experimental
Concurrent Choice Session- Lab 2
Participants will make choices between two menthol e-cigarettes with different levels of nicotine.
  • 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

Recruiting Locations

Yale School of Medicine
New Haven, Connecticut 06473
Contact:
Danielle R Davis, PhD
203-974-7607
danielle.davis@yale.edu

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Danielle R Davis, PhD
2039747607
danielle.davis@yale.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.