Nicotine DependenceNCT07398976
Sex Differences in E-Cigarette Perception
A study testing Nicotine Level 1 (0mg/ml), Nicotine Level 2 (36mg/ml) and Nicotine Level 3 (59mg/ml) in people with Nicotine Dependence and E-cigarette Use, run by Yale University at 1 site in United States.
Trial summary
This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine. Read more about this study
- Who is it for?
- Ages 21 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, E-cigarette Use
- What is being tested?
- Nicotine Level 1 (0mg/ml), Nicotine Level 2 (36mg/ml) and Nicotine Level 3 (59mg/ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read/write in English
- Current cigarette smoking
- Prior e-cigarette exposure
- Biochemically verified cigarette use
- Not trying to quit tobacco use
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06473
Danielle R Davis, PhD, 203-974-7607, danielle.davis@yale.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Nicotine Dependence, E-cigarette Use
- Being tested
- Nicotine Level 1 (0mg/ml), Nicotine Level 2 (36mg/ml), Nicotine Level 3 (59mg/ml)
- Keywords
- Sex Differences, Females, E-cigarettes, Menthol, Nicotine, Vaping
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Level 1 (0mg/ml)Other
Menthol with be paired with 0mg/ml nicotine in an e-cigarette
Nicotine Level 2 (36mg/ml)Other
Menthol with be paired with 36mg/ml nicotine in an e-cigarette
Nicotine Level 3 (59mg/ml)Other
Menthol with be paired with 59mg/ml nicotine in an e-cigarette
| Study group | Role | What they receive |
|---|---|---|
| Sampling Session - Lab 1 | Experimental | Participants will sample and rate three menthol flavored e-cigarettes with varying levels of nicotine. Receives: 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. Receives: Other: Nicotine Level 1 (0mg/ml); Other: Nicotine Level 2 (36mg/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Choices
Differences in proportion of choices for the two menthol e-cigarette for males and females in the Lab 2 preference task
Measured: 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
Measured: During the 3 hour period of the Lab 2 preference task
Secondary outcomes (1)
Reward
Difference in scores (range: 0-100) of the Liking/Wanting Subscale of the Drug Effects Questionnaire
Measured: Immediately (~2 minutes) after e-cigarette exposures in Lab 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start30 Jul 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Danielle R Davis, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398976
- Sponsor's protocol ID
- 2000041248
- Other IDs
- 5K01DA056494
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in E-Cigarette Perception: Study 2
- ClinicalTrials.gov ID
- NCT07398976
- Acronym / sponsor ID
- 2000041248
- Conditions
- Nicotine Dependence, E-cigarette Use
- Keywords
- Sex Differences, Females, E-cigarettes, Menthol, Nicotine, Vaping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sampling Session - Lab 1 | Experimental | Other: Nicotine Level 1 (0mg/ml), Other: Nicotine Level 2 (36mg/ml), Other: Nicotine Level 3 (59mg/ml)Participants will sample and rate three menthol flavored e-cigarettes with varying levels of nicotine. |
| Concurrent Choice Session- Lab 2 | Experimental | Other: Nicotine Level 1 (0mg/ml), Other: Nicotine Level 2 (36mg/ml)Participants will make choices between two menthol e-cigarettes with different levels of nicotine. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to read/write in English
- Current cigarette smoking
- Prior e-cigarette exposure
- Biochemically verified cigarette use
- Not trying to quit tobacco use
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Level 1 (0mg/ml)Menthol with be paired with 0mg/ml nicotine in an e-cigarette | Other | Concurrent Choice Session- Lab 2, Sampling Session - Lab 1 |
| Nicotine Level 2 (36mg/ml)Menthol with be paired with 36mg/ml nicotine in an e-cigarette | Other | Concurrent Choice Session- Lab 2, Sampling Session - Lab 1 |
| Nicotine Level 3 (59mg/ml)Menthol with be paired with 59mg/ml nicotine in an e-cigarette | Other | Sampling Session - Lab 1 |
Primary outcome
Proportion of Choices
Time frame: 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
Time frame: 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
1 secondary outcome
Reward
Time frame: Immediately (~2 minutes) after e-cigarette exposures in Lab 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Investigator may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle R Davis, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Level 1 (0mg/ml), Nicotine Level 2 (36mg/ml) and Nicotine Level 3 (59mg/ml) in people with Nicotine Dependence and E-cigarette Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle R Davis, PhD (2039747607, danielle.davis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Choices (time frame: For the 3 hour period of the Lab 2 preference task). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.