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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental E-Liquid Order "A" | Experimental | 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. |
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| Experimental E-Liquid Order "B" | Experimental | 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. |
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| Experimental E-Liquid Order "C" | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water Concentration 1 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Irritation/Harshness | 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 | 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Davis, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42161504 | Derived | Davis D, Green BG, Krishnan-Sarin S, Martin TD, Wu R, Gueorguieva R, Anastas PT, Zimmerman JB, O'Malley S, Allen W, Erythropel HC. Water addition to e-liquids to reduce flavour aldehyde acetal formation: chemistry and user sensory experience and appeal. Tob Control. 2026 May 20:tc-2025-060013. doi: 10.1136/tc-2025-060013. Online ahead of print. |
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31 of 54 intakes were randomized to receive study procedures. 22 people did not meet inclusion criteria at the time of intake and were not enrolled and 1 person was not available at the time of the lab sessions to participate.
108 people were phone screened for eligibility. 54 attended an in person intake appointment. Of those, 31 met inclusion criteria and were enrolled in the study and 30 participants complete all study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
| FG001 | 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
| FG002 | 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
| FG003 | 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Order A-D (All Participants Received All Conditions, Order Was Randomized) | All participants received all conditions, order was randomized |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Irritation/Harshness | 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). | Posted | Mean | Standard Deviation | units on a scale | immediately after intervention, up to 15 minutes |
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Data was collected from August 2022 to March 2023 and adverse events were assessed during that time. Participants were monitored for adverse events during the duration of their participation (i.e. they were asked about adverse events and monitored for AEs during Labs 1 and 2). For each participant the time they were enrolled varied, but it was approximately 1-2 weeks.
Does not differ from clinical trials definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle Davis | Yale University | 2039747607 | danielle.davis@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Feb 29, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2022 | Feb 29, 2024 | ICF_002.pdf |
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Within subject design, all participants will receive all e-liquid flavors/water concentrations
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Double blind, both participant and investigator will be blind to e-liquid being administered
| Experimental E-Liquid Order "D" |
| Experimental |
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. |
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| Water Concentration 2 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. |
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| Water Concentration 3 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. |
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| Water Concentration 4 | Other | E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 5% Water Added |
All participants received all conditions |
| OG002 | 10% Water Added | All participants received all conditions. |
| OG003 | 20% Water Added | All participants received all conditions. |
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| Primary | Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100 | 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). | Posted | Mean | Standard Deviation | score on a scale (-100 to 100) | immediately after intervention, up to 15 minutes |
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| Primary | Appeal Assessed Using the Drug Effects Questionnaire (DEQ) | 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). | Posted | Mean | Standard Error | score on a scale | immediately after intervention, up to 15 minutes |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Experimental 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Experimental 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Experimental 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 will be presented in the same order from hypothesized least irritating to most irritating. Water Concentration 1: E-liquid containing 36mg/ml pronated nicotine will be administered with no alteration to water concentration. Water Concentration 2: E-liquid containing 36mg/ml pronated nicotine will be administered with 5% total water concentration of e-liquid. Water Concentration 3: E-liquid containing 36mg/ml pronated nicotine will be administered with 10% total water concentration of e-liquid. Water Concentration 4: E-liquid containing 36mg/ml pronated nicotine will be administered with 20% total water concentration of e-liquid. | 0 | 7 | 0 | 7 | 0 | 7 |
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