Effects of E-cigarette Flavors on Youth TCORS 2.0

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of E-cigarette Flavors on Youth

Conditions
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Nicotine Use Disorder

Intervention / Treatment
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* Drug: Flavoring Agents
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sweet non-menthol, nicotine 36mg/ml<br>Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine | Drug: Flavoring Agents<br>* Flavor of e-liquid - sweet or tobacco<br>Drug: Nicotine<br>* Nicotine level (0, 3, or 12 mg)<br>|
| Experimental: Sweet menthol, nicotine 36mg/ml<br>Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine | Drug: Flavoring Agents<br>* Flavor of e-liquid - sweet or tobacco<br>Drug: Nicotine<br>* Nicotine level (0, 3, or 12 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liking: Difference score in liking/wanting of each e-cigarette condition | 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). | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | 
| Reinforcing Efficacy: Difference score in drug effects of each e-cigarette condition | 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). | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | 
| Craving: change in craving score for e-cigarette | 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). | At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) | 
| Irritation/Harshness: Difference score in irritation of harshness of each e-cigarette condition | 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). | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |