Water Content in E-Liquids

Yale University

Status: Completed

Conditions: Nicotine E-Cigarette Use

Treatments: Other: Water Concentration 4; Other: Water Concentration 1; Other: Water Concentration 2; Other: Water Concentration 3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05257109

2000031495

2U54DA036151-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 4 patient groups

Experimental E-Liquid Order "A"

Experimental group

Description:

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 order will be randomized.

Treatment:

Other: Water Concentration 3

Other: Water Concentration 2

Other: Water Concentration 1

Other: Water Concentration 4

Experimental E-Liquid Order "B"

Experimental group

Description:

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 order will be randomized.

Treatment:

Other: Water Concentration 3

Other: Water Concentration 2

Other: Water Concentration 1

Other: Water Concentration 4

Experimental E-Liquid Order "C"

Experimental group

Description:

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 order will be randomized.

Treatment:

Other: Water Concentration 3

Other: Water Concentration 2

Other: Water Concentration 1

Other: Water Concentration 4

Experimental E-Liquid Order "D"

Experimental group

Description:

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 order will be randomized.

Treatment:

Other: Water Concentration 3

Other: Water Concentration 2

Other: Water Concentration 1

Other: Water Concentration 4