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Completed

NCT Number: NCT03634839

Effects of E-cigarette Flavors on Youth TCORS 2.0

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Completed

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Key information

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

About this study

Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 18-20 years
  • Able to read and write
  • Used e-cigs at least 10 times in lifetime
  • Used e-cigs in past 30 days

Exclusion criteria

  • Current use of non-prescription substances besides nicotine, marijuana, alcohol
  • Any significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol
  • Pregnant or lactating females
  • Uncontrolled asthma
  • Nut/e-liquid flavorant allergy
  • current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Treatment and study plan

Flavoring Agents

Drug

Flavor of e-liquid - sweet or tobacco

Other names: Cooling flavor

nicotine

Drug

Nicotine level (36 mg/ml)

Other names: Nicotine concentration

Primary outcomes

  1. Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition

    Time frame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)

    The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100.

  2. Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition

    Time frame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)

    Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects).

  3. Craving: Change in Craving Score for E-cigarette

    Time frame: At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)

    Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes 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).

  4. Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition

    Time frame: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)

    Difference in irritation at each e-cigarette condition 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Effects of E-cigarette Flavors on Youth

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Aug 9, 2024

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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