Sex Differences in E-cig Perception: Study 1
- Conditions
- E-Cig UseNicotine AddictionCigarette SmokingSex Differences
- Interventions
- Other: E-liquid Flavor 1Other: E-liquid Flavor 2Other: E-liquid Flavor 3
- Registration Number
- NCT05432830
- Lead Sponsor
- Yale University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental E-Liquid Order "B" E-liquid Flavor 1 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). Experimental E-Liquid Order "C" E-liquid Flavor 1 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). Experimental E-Liquid Order "B" E-liquid Flavor 2 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). Experimental E-Liquid Order "A" E-liquid Flavor 1 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). Experimental E-Liquid Order "A" E-liquid Flavor 2 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). Experimental E-Liquid Order "A" E-liquid Flavor 3 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). Experimental E-Liquid Order "B" E-liquid Flavor 3 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). Experimental E-Liquid Order "C" E-liquid Flavor 2 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). Experimental E-Liquid Order "C" E-liquid Flavor 3 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).
- Primary Outcome Measures
Name Time Method Reinforcing Efficacy immediately after intervention, up to 15 minutes 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.
Appeal immediately after intervention, up to 15 minutes 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.
Sensory Effects immediately after intervention, up to 15 minutes 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Connecticut Mental Health Center
🇺🇸New Haven, Connecticut, United States