Nicotine AddictionNCT05432830

Sex Differences in E-cig Perception: Study 1

A study testing E-liquid Flavor 1, E-liquid Flavor 2 and E-liquid Flavor 3 in people with Nicotine Addiction and E-Cig Use, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling. Read more about this study

Who is it for?: Ages 21 to 44 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Addiction, E-Cig Use, Cigarette Smoking
What is being tested?: E-liquid Flavor 1, E-liquid Flavor 2 and E-liquid Flavor 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2024to 18 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

21-44 years old
Able to read/write
Current cigarette smoking
Recent E-cig Exposure (>/= 10 uses in past 6 mo.)
Urine cot >200ng/ml
Willing to abstain from nicotine/tobacco 6-8hrs prior to lab session
Not looking to quit

Who cannot join

Untreated chronic medical conditions
Non-stable Rx medication
Illicit drug use
Pregnant, trying to become pregnant, breastfeeding
Not fully vaccinated for Coronavirus (e.g. COVID-19)

Trial locations and contacts

1 site in 1 country.

United States1 site

Connecticut Mental Health Center
New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1

The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

Read the detailed description

This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.

Conditions: Nicotine Addiction, E-Cig Use, Cigarette Smoking, Sex Differences
Being tested: E-liquid Flavor 1, E-liquid Flavor 2, E-liquid Flavor 3
Medical subject headings: Tobacco Use Disorder, Vaping, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E-liquid Flavor 1Other
E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.
E-liquid Flavor 2Other
E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.
E-liquid Flavor 3Other
E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Study groups in NCT05432830
Study group	Role	What they receive
Experimental E-Liquid Order "A"	Experimental	All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). Receives: Other: E-liquid Flavor 1; Other: E-liquid Flavor 2; Other: E-liquid Flavor 3
Experimental E-Liquid Order "B"	Experimental	All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). Receives: Other: E-liquid Flavor 1; Other: E-liquid Flavor 2; Other: E-liquid Flavor 3
Experimental E-Liquid Order "C"	Experimental	All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits). Receives: Other: E-liquid Flavor 1; Other: E-liquid Flavor 2; Other: E-liquid Flavor 3

What is being measured

The primary outcome is the main question the study is designed to answer.

Appeal
Change in appeal at each flavor as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' as midpoint.
Measured: immediately after intervention (up to 15 minutes)
Sensory Effects Assessed Using the Computerized Generalized Labeled Magnitude Scale (gLMS)
Change in sweetness at each flavor as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
Measured: immediately after intervention (up to 15 minutes)
Reinforcing Efficacy of Multiple Choice Procedure
Change in reinforcing value at each flavor via the Multiple Choice Procedure. Participants will use the Multiple Choice Procedure to self-report their responses using a computer mouse to indicate where across a series of options their answer falls. Following each puffing bout, participants will be asked to make discrete hypothetical choices between 10-puffs of the e-cig they had just used or a series of 10 monetary values ranging from $0.01 to $5.12. The minimum monetary value at which money is chosen over the e-cig puffs is a contingency-based estimate of e-cig value.
Measured: immediately after intervention (up to 15 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202418 Jul 2025

First posted27 Jun 2022
Study start30 Apr 2024
Primary completion18 Jul 2025
Study completion18 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nicotine AddictionStudies 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: Within subject design, all participants will receive all flavors
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05432830
Sponsor's protocol ID: 2000032981
Other IDs: 1K01DA056494-01
Status last verified: Sep 2026
First submitted: 21 Jun 2022
Last updated: 2 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1
ClinicalTrials.gov ID: NCT05432830
Acronym / sponsor ID: 2000032981
Conditions: Nicotine Addiction, E-Cig Use, Cigarette Smoking, Sex Differences
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 30 Apr 2024 (actual)
Primary completion: 18 Jul 2025 (actual)
Study completion: 18 Jul 2025 (actual)
First posted: 27 Jun 2022 (actual)
Results: Posted 2 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Within subject design, all participants will receive all flavors

Arm	Type	Receives
Experimental E-Liquid Order "A"	Experimental	Other: E-liquid Flavor 1, Other: E-liquid Flavor 2, Other: E-liquid Flavor 3All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
Experimental E-Liquid Order "B"	Experimental	Other: E-liquid Flavor 1, Other: E-liquid Flavor 2, Other: E-liquid Flavor 3All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
Experimental E-Liquid Order "C"	Experimental	Other: E-liquid Flavor 1, Other: E-liquid Flavor 2, Other: E-liquid Flavor 3All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).

Who may qualify

Ages: 21 to 44 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

21-44 years old
Able to read/write
Current cigarette smoking
Recent E-cig Exposure (>/= 10 uses in past 6 mo.)
Urine cot >200ng/ml

Key exclusion criteria (5 listed)

Untreated chronic medical conditions
Non-stable Rx medication
Illicit drug use
Pregnant, trying to become pregnant, breastfeeding
Not fully vaccinated for Coronavirus (e.g. COVID-19)

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
E-liquid Flavor 1E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.	Other	Experimental E-Liquid Order "A", Experimental E-Liquid Order "B", Experimental E-Liquid Order "C"
E-liquid Flavor 2E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.	Other	Experimental E-Liquid Order "A", Experimental E-Liquid Order "B", Experimental E-Liquid Order "C"
E-liquid Flavor 3E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.	Other	Experimental E-Liquid Order "A", Experimental E-Liquid Order "B", Experimental E-Liquid Order "C"

Primary outcome

Appeal
Time frame: immediately after intervention (up to 15 minutes)
Change in appeal at each flavor as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' as midpoint.
Sensory Effects Assessed Using the Computerized Generalized Labeled Magnitude Scale (gLMS)
Time frame: immediately after intervention (up to 15 minutes)
Change in sweetness at each flavor as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
Reinforcing Efficacy of Multiple Choice Procedure
Time frame: immediately after intervention (up to 15 minutes)
Change in reinforcing value at each flavor via the Multiple Choice Procedure. Participants will use the Multiple Choice Procedure to self-report their responses using a computer mouse to indicate where across a series of options their answer falls. Following each puffing bout, participants will be asked to make discrete hypothetical choices between 10-puffs of the e-cig they had just used or a series of 10 monetary values ranging from $0.01 to $5.12. The minimum monetary value at which money is chosen over the e-cig puffs is a contingency-based estimate of e-cig value.

Results and safety

Results posted to the registry on 2 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Condition 1: Strawberry, Then Menthol, Then Unflavored	10	10
Condition 2: Strawberry, Unflavored, Menthol	11	10
Condition 3: Menthol, Strawberry, Unflavored	11	10
Condition 4: Menthol, Unflavored, Strawberry	10	10
Condition 5: Unflavored, Strawberry, Menthol	11	9
Condition 6: Unflavored, Menthol, Strawberry	13	12

Primary outcome: Appeal

Time frame: immediately after intervention (up to 15 minutes). Mean (Standard Error). Unit: units on a scale

Measure	Males - Strawberry Flavor n = 31	Males - Menthol Flavor n = 31	Males - Unflavored n = 31	Females - Strawberry Flavor n = 31	Females - Menthol Flavor n = 31	Females - Unflavored n = 30
Value	18.20 (5.27)	14.93 (7.04)	-5.98 (7.30)	13.99 (7.52)	7.88 (7.76)	-5.12 (6.25)

Males - Strawberry Flavor vs Males - Menthol Flavor vs Males - Unflavored vs Females - Strawberry Flavor vs Females - Menthol Flavor vs Females - Unflavored: p = 0.79, Mixed Models Analysis

Primary outcome: Sensory Effects Assessed Using the Computerized Generalized Labeled Magnitude Scale (gLMS)

Time frame: immediately after intervention (up to 15 minutes). Mean (Standard Error). Unit: sweetness score on the gLMS scale

Measure	Males - Strawberry Flavor n = 31	Males - Menthol Flavor n = 31	Males - Unflavored n = 31	Females - Strawberry Flavor n = 31	Females - Menthol Flavor n = 31	Females - Unflavored n = 30
Value	24.73 (3.39)	17.61 (3.09)	10.84 (2.64)	20.62 (3.66)	11.59 (2.39)	7.90 (1.98)

Males - Strawberry Flavor vs Males - Menthol Flavor vs Males - Unflavored vs Females - Strawberry Flavor vs Females - Menthol Flavor vs Females - Unflavored: p = 0.77, Mixed Models Analysis

Primary outcome: Reinforcing Efficacy of Multiple Choice Procedure

Time frame: immediately after intervention (up to 15 minutes). Mean (Standard Error). Unit: dollars

Measure	Males - Strawberry Flavor n = 31	Males - Menthol Flavor n = 31	Males - Unflavored n = 31	Females - Strawberry Flavor n = 31	Females - Menthol Flavor n = 31	Females - Unflavored n = 31
Value	2.59 (0.51)	2.82 (0.61)	1.98 (0.53)	2.85 (0.61)	1.99 (0.45)	2.38 (0.43)

Males - Strawberry Flavor vs Males - Menthol Flavor vs Males - Unflavored vs Females - Strawberry Flavor vs Females - Menthol Flavor vs Females - Unflavored: p = 0.19, Mixed Models Analysis

Adverse events

Time frame: Adverse events were collected beginning at Lab 1 through Lab 4, including any Adverse events that occur between visits. This time period varies by participants but is approximately 1 week to 1 month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Strawberry Flavor	1 of 66 (1.5%)	2 of 66 (3%)	0 of 66
Menthol Flavor	1 of 66 (1.5%)	1 of 66 (1.5%)	0 of 66
Unflavored	0 of 66 (0%)	0 of 66 (0%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Danielle Davis 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 E-liquid Flavor 1, E-liquid Flavor 2 and E-liquid Flavor 3 in people with Nicotine Addiction and E-Cig 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 7 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: finished, as of the sponsor's last update on 2 Oct 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?

Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appeal (time frame: immediately after intervention (up to 15 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432830.

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 Oct 2026.