Water Content in E-Liquids

Not Applicable

Completed

• Conditions: Nicotine E-Cigarette Use
• Interventions: Other: Water Concentration 1; Other: Water Concentration 2; Other: Water Concentration 3; Other: Water Concentration 4

• Registration Number: NCT05257109
• Lead Sponsor: Yale University

Brief Summary

This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.

Detailed Description

This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception. Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids. Each e-liquid will be sampled in four water concentration manipulations. Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Study Start: 2022-08-01
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Results First Submitted: 2024-03-01
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Results First Posted: 2024-10-22
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• at least 21 years old
• able to read/write
• >/= 6 mths e-cig use
• regular e-cig use (>/= 4 days/week)
• use of flavored e-cigs
• use of nicotine containing e-cigs
• urine cotinine >/= 200ng/ml
• no plan to quit e-cig use

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Exclusion Criteria

• breastfeeding, pregnant, trying to become pregnant
• Medical conditions that increase risk of respiratory problems among participants
• Current use of illegal substances
• Medical conditions increasing risk of respiratory problems in nonpatient populations
• Current diagnosis of an untreated psychiatric condition
• Not fully vaccinated for Coronavirus-19

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental E-Liquid Order "C"	Water Concentration 4	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "A"	Water Concentration 1	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "A"	Water Concentration 2	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "A"	Water Concentration 3	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "B"	Water Concentration 2	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "B"	Water Concentration 4	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "D"	Water Concentration 1	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "D"	Water Concentration 2	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "D"	Water Concentration 4	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "A"	Water Concentration 4	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "B"	Water Concentration 3	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "C"	Water Concentration 1	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "C"	Water Concentration 2	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "D"	Water Concentration 3	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "B"	Water Concentration 1	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.
Experimental E-Liquid Order "C"	Water Concentration 3	All participants will be given all e-liquids (i.e. all 16 flavor\*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water will be presented in the same order from hypothesized least irritating to most irritating.

Primary Outcome Measures

Name	Time	Method
Irritation/Harshness	immediately after intervention, up to 15 minutes	Change in irritation at each water level 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).
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100	immediately after intervention, up to 15 minutes	Change in appeal at each water level 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, minimum score) to 100 (most liked, maximum score), with 'neither liked nor disliked' as midpoint (0). Scores range from -100 (minimum) to 100 (maximum). Negative scores indicate dislike (lack of appeal) and positive scores indicate liking (appeal).
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)	immediately after intervention, up to 15 minutes	Change in appeal at each water level 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).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States