Water Content in E-Liquids
September 27, 2024 updated by: Yale University
Water Content In E-Liquids
This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception.
Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids.
Each e-liquid will be sampled in four water concentration manipulations.
Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- at least 21 years old
- able to read/write
- >/= 6 mths e-cig use
- regular e-cig use (>/= 4 days/week)
- use of flavored e-cigs
- use of nicotine containing e-cigs
- urine cotinine >/= 200ng/ml
- no plan to quit e-cig use
Exclusion Criteria:
- breastfeeding, pregnant, trying to become pregnant
- Medical conditions that increase risk of respiratory problems among participants
- Current use of illegal substances
- Medical conditions increasing risk of respiratory problems in nonpatient populations
- Current diagnosis of an untreated psychiatric condition
- Not fully vaccinated for Coronavirus-19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e.
all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study.
Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits).
For each flavor condition, water order will be randomized.
|
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
|
Experimental: Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e.
all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study.
Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits).
For each flavor condition, water order will be randomized.
|
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
|
Experimental: Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e.
all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study.
Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits).
For each flavor condition, water order will be randomized.
|
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
|
Experimental: Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e.
all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study.
Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits).
For each flavor condition, water order will be randomized.
|
E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration.
E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid.
E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Irritation/Harshness
Time Frame: immediately after intervention, up to 15 minutes
|
Change in irritation at each water level 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
|
|
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100
Time Frame: immediately after intervention, up to 15 minutes
|
Change in appeal at each water level 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, minimum score) to 100 (most liked, maximum score), with 'neither liked nor disliked' as midpoint (0).
Scores range from -100 (minimum) to 100 (maximum).
Negative scores indicate dislike (lack of appeal) and positive scores indicate liking (appeal).
|
immediately after intervention, up to 15 minutes
|
|
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)
Time Frame: immediately after intervention, up to 15 minutes
|
Change in appeal at each water level as measured by the computerized version of the Drug Effects Questionnaire (DEQ).
Participants will self-report their responses using a computer mouse to indicate where on the scale response falls.
A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).
|
immediately after intervention, up to 15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Danielle Davis, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
March 10, 2023
Study Completion (Actual)
March 10, 2023
Study Registration Dates
First Submitted
February 11, 2022
First Submitted That Met QC Criteria
February 16, 2022
First Posted (Actual)
February 25, 2022
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
September 27, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2000031495
- 2U54DA036151-06 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.