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Completed

NCT Number: NCT05432830

Sex Differences in E-cig Perception: 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.

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Key information

Age range

21 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

E-liquid Flavor 1

Other

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

E-liquid Flavor 2

Other

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

E-liquid Flavor 3

Other

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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