Sex Differences in E-Cigarette Perception

Sex Differences in E-Cigarette Perception: Study 2

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nicotine Dependence; E-cigarette Use
• Intervention / Treatment: Other: Nicotine Level 1 (0mg/ml); Other: Nicotine Level 2 (36mg/ml); Other: Nicotine Level 3 (59mg/ml)

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle R Davis, PhD; Phone Number: 2039747607; Email: danielle.davis@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06473
      • Yale School of Medicine
      • Contact: Danielle R Davis, PhD; Phone Number: 203-974-7607; Email: danielle.davis@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Choices	Differences in proportion of choices for the two menthol e-cigarette for males and females in the Lab 2 preference task	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	During the 3 hour period of the Lab 2 preference task

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reward	Difference in scores (range: 0-100) of the Liking/Wanting Subscale of the Drug Effects Questionnaire	Immediately (~2 minutes) after e-cigarette exposures in Lab 1

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Danielle R Davis, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nicotine; Menthol; Vaping; Females; Sex Differences; E-cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Use Disorder; Vaping
• Other Study ID Numbers: 2000041248; 5K01DA056494 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
• IPD Sharing Access Criteria: The de-identified data may be made available for research purposes after study publication by contacting the PI.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No