Cigarette Smoking, E-Cig Use, Nicotine Addiction, Sex Differences
Conditions
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.
Interventions
OTHERE-liquid Flavor 1
E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.
OTHERE-liquid Flavor 2
E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.
OTHERE-liquid Flavor 3
E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind, both participant and investigator will be blind to e-liquid being administered
Intervention model description
Within subject design, all participants will receive all flavors
Eligibility
Sex/Gender
ALL
Age
21 Years to 44 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle Davis
Yale University
Outcome results
None listed