Sex Differences in E-cig Perception: Study 1
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ClinicalTrials.gov Identifier: NCT05432830 |
Recruitment Status :
Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : March 4, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
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).
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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. |
- 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.
- 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).
- 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 |
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)
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
Contact: Danielle R Davis | 203-974-7607 | danielle.davis@yale.edu |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |