Sex Differences in E-cig Perception: Study 1

Cigarette Smoking Clinical Trial

Official title:

Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432830
• Other study ID #: 2000032981
• Secondary ID: 1K01DA056494-01
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Danielle R Davis
• Phone: 203-974-7607
• Email: danielle.davis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cigarette Smoking
• E-Cig Use
• Nicotine Addiction
• Sex Differences
• Tobacco Use Disorder

Intervention

Other:
• E-liquid Flavor 1
E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.
• E-liquid Flavor 2
E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.
• E-liquid Flavor 3
E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appeal	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.	immediately after intervention, up to 15 minutes
Primary	Sensory Effects	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).	immediately after intervention, up to 15 minutes
Primary	Reinforcing Efficacy	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.	immediately after intervention, up to 15 minutes