Sex Differences in E-cig Perception: Study 1

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nicotine Addiction, E-Cig Use, Cigarette Smoking, Sex Differences

Intervention / Treatment
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* Other: E-liquid Flavor 1
* Other: E-liquid Flavor 2
* Other: E-liquid Flavor 3


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Within subject design, all participants will receive all flavors
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appeal | 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 | 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 | 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 |