Sex Differences in E-cig Perception: Study 1

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432830
Collaborator
(none)
60
3
19

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: E-liquid Flavor 1
  • Other: E-liquid Flavor 2
  • Other: E-liquid Flavor 3
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Within subject design, all participants will receive all flavorsWithin subject design, all participants will receive all flavors
Masking:
Double (Participant, Investigator)
Masking Description:
Double blind, both participant and investigator will be blind to e-liquid being administered
Primary Purpose:
Other
Official Title:
Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental E-Liquid Order "A"

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

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

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

Experimental: Experimental E-Liquid Order "B"

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

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

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

Experimental: Experimental E-Liquid Order "C"

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 44 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05432830
Other Study ID Numbers:
  • 2000032981
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022