Sex Differences in E-cig Perception: Study 1

Yale University

Status: Completed

Conditions: Cigarette Smoking; Sex Differences; Nicotine Addiction; E-Cig Use

Treatments: Other: E-liquid Flavor 2; Other: E-liquid Flavor 3; Other: E-liquid Flavor 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05432830

2000032981

1K01DA056494-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 21 to 44 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Experimental E-Liquid Order "A"

Experimental group

Description:

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).

Treatment:

Other: E-liquid Flavor 1

Other: E-liquid Flavor 3

Other: E-liquid Flavor 2

Experimental E-Liquid Order "B"

Experimental group

Description:

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).

Treatment:

Other: E-liquid Flavor 1

Other: E-liquid Flavor 3

Other: E-liquid Flavor 2

Experimental E-Liquid Order "C"

Experimental group

Description:

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).

Treatment:

Other: E-liquid Flavor 1

Other: E-liquid Flavor 3

Other: E-liquid Flavor 2