Sex Differences in E-cig Perception: Study 1

January 26, 2026 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately after intervention, up to 15 minutes
Sensory Effects
Time Frame: immediately after intervention, up to 15 minutes
Change in sweetness, coolness, irritation, and bitterness 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).
immediately after intervention, up to 15 minutes
Reinforcing Efficacy
Time Frame: immediately after intervention, up to 15 minutes
Change in reinforcing value at each flavor. Participants will use the multiple choice procedure to self-report their responses using a computer mouse to indicate where on the scale response 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 44 monetary values ($0.25-$15.06). The minimum monetary value at which money is chosen over the e-cig puffs is a contingency-based estimate of e-cig value. At the end of each lab session, participants will be given a choice between another 10 e-cig puffs or one of the monetary amounts they picked in the Multiple Choice Procedures completed earlier.
immediately after intervention, up to 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Danielle Davis, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2024

Primary Completion (Actual)

July 18, 2025

Study Completion (Actual)

July 18, 2025

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000032981
  • 1K01DA056494-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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