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Sex Differences in E-cig Perception: Study 1

Primary Purpose

Nicotine Addiction, E-Cig Use, Cigarette Smoking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E-liquid Flavor 1
E-liquid Flavor 2
E-liquid Flavor 3
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nicotine Addiction

Eligibility Criteria

21 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Experimental E-Liquid Order "A"

    Experimental E-Liquid Order "B"

    Experimental E-Liquid Order "C"

    Arm Description

    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).

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2022
    Last Updated
    March 8, 2023
    Sponsor
    Yale University
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05432830
    Brief Title
    Sex Differences in E-cig Perception: Study 1
    Official Title
    Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nicotine Addiction, E-Cig Use, Cigarette Smoking, Sex Differences

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Within subject design, all participants will receive all flavors
    Masking
    ParticipantInvestigator
    Masking Description
    Double blind, both participant and investigator will be blind to e-liquid being administered
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental E-Liquid Order "A"
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Experimental E-Liquid Order "B"
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Experimental E-Liquid Order "C"
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    E-liquid Flavor 1
    Intervention Description
    E-liquid containing 36mg/ml pronated nicotine will be administered with sweet e-cigarette flavor.
    Intervention Type
    Other
    Intervention Name(s)
    E-liquid Flavor 2
    Intervention Description
    E-liquid containing 36mg/ml pronated nicotine will be administered with cooling e-cigarette flavor.
    Intervention Type
    Other
    Intervention Name(s)
    E-liquid Flavor 3
    Intervention Description
    E-liquid containing 36mg/ml pronated nicotine will be administered with unflavored e-cigarette flavor.
    Primary Outcome Measure Information:
    Title
    Appeal
    Description
    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.
    Time Frame
    immediately after intervention, up to 15 minutes
    Title
    Sensory Effects
    Description
    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).
    Time Frame
    immediately after intervention, up to 15 minutes
    Title
    Reinforcing Efficacy
    Description
    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.
    Time Frame
    immediately after intervention, up to 15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Danielle R Davis
    Phone
    203-974-7607
    Email
    danielle.davis@yale.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Sex Differences in E-cig Perception: Study 1

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