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Sex Differences in E-cig Perception: Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05432830
Recruitment Status : Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : March 4, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nicotine Addiction E-Cig Use Cigarette Smoking Sex Differences Other: E-liquid Flavor 1 Other: E-liquid Flavor 2 Other: E-liquid Flavor 3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Within 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
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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.




Primary Outcome Measures :
  1. Appeal [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432830


Contacts
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Contact: Danielle R Davis 203-974-7607 danielle.davis@yale.edu

Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT05432830    
Other Study ID Numbers: 2000032981
1K01DA056494-01 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders