Effects of E-cigarette Flavors on Youth TCORS 2.0

Phase 1

Completed

• Conditions: Nicotine Use Disorder
• Interventions: Drug: Flavoring Agents; Drug: Nicotine

• Registration Number: NCT03634839
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-17
• Study Start: 2022-11-07
• Primary Completion: 2023-06-16
• Study Completion: 2023-07-20
• Results First Submitted: 2024-06-13
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Results First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sweet menthol, nicotine 36mg/ml	Flavoring Agents	Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Sweet non-menthol, nicotine 36mg/ml	Flavoring Agents	Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Sweet non-menthol, nicotine 36mg/ml	Nicotine	Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Sweet menthol, nicotine 36mg/ml	Nicotine	Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine

Primary Outcome Measures

Name	Time	Method
Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition	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.
Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition	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).
Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition	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).
Craving: Change in Craving Score for E-cigarette	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).

Trial Locations

Locations (1)

CMHC, Substance Abuse Center; 🇺🇸 New Haven, Connecticut, United States