Sex Differences in E-cig Perception: Study 1

NCT05432830 | Completed DMC

• 2 other identifiers: 20000329811K01DA056494-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Experimental E-Liquid Order "A"

EXPERIMENTAL

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).

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

Experimental E-Liquid Order "B"

EXPERIMENTAL

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).

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

Experimental E-Liquid Order "C"

EXPERIMENTAL

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).

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

Interventions

E-liquid Flavor 2 OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.

Experimental E-Liquid Order "A"; Experimental E-Liquid Order "B"; Experimental E-Liquid Order "C"

E-liquid Flavor 3 OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.

Experimental E-Liquid Order "A"; Experimental E-Liquid Order "B"; Experimental E-Liquid Order "C"

E-liquid Flavor 1 OTHER

E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.

Experimental E-Liquid Order "A"; Experimental E-Liquid Order "B"; Experimental E-Liquid Order "C"

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Danielle Davis

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, both participant and investigator will be blind to e-liquid being administered
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subject design, all participants will receive all flavors

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: April 30, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)