NCT07398976

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

January 26, 2026

Last Update Submit

May 18, 2026

Conditions

Nicotine DependenceE-cigarette Use

Keywords

Sex DifferencesFemalesE-cigarettesMentholNicotineVaping

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Reward

    Immediately (~2 minutes) after e-cigarette exposures in Lab 1

Study Arms (2)

Sampling Session - Lab 1

EXPERIMENTAL

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)

Concurrent Choice Session- Lab 2

EXPERIMENTAL

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)

Interventions

Nicotine Level 3 (59mg/ml)OTHER

Menthol with be paired with 59mg/ml nicotine in an e-cigarette

Sampling Session - Lab 1
Nicotine Level 1 (0mg/ml)OTHER

Menthol with be paired with 0mg/ml nicotine in an e-cigarette

Concurrent Choice Session- Lab 2Sampling Session - Lab 1
Nicotine Level 2 (36mg/ml)OTHER

Menthol with be paired with 36mg/ml nicotine in an e-cigarette

Concurrent Choice Session- Lab 2Sampling Session - Lab 1

Eligibility Criteria

Age21 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to read/write in English
  • Current cigarette smoking
  • Prior e-cigarette exposure
  • Biochemically verified cigarette use
  • Not trying to quit tobacco use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06473, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderVaping

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehavior

Study Officials

  • Danielle R Davis, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle R Davis, PhD

CONTACT

2039747607danielle.davis@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 10, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.

Shared Documents
ICF
Access Criteria
The de-identified data may be made available for research purposes after study publication by contacting the PI.

Locations

US(1)