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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 is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.
Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweet non-menthol, nicotine 36mg/ml | Experimental | Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine |
|
| Sweet menthol, nicotine 36mg/ml | Experimental | Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavoring Agents | Drug | Flavor of e-liquid - sweet or tobacco |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition | The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100. | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
| Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition | Difference between e-cigarette effects for each e-cigarette condition 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). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects). | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
| Craving: Change in Craving Score for E-cigarette | Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes 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). | At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC, Substance Abuse Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19833660 | Background | Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054. | |
| 40489161 | Derived | Li W, Davis DR, Wu R, Gueorguieva R, Green BG, Krishnan-Sarin S. The effect of "ice" components in sweet-flavored nicotine-containing e-liquids among young adult e-cigarette users. Exp Clin Psychopharmacol. 2025 Oct;33(5):477-482. doi: 10.1037/pha0000786. Epub 2025 Jun 9. |
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A total of 40 participants completed the study. Specifically, 49 out of 84 participants were randomized, but 7 did not show up and 2 withdrew. Of the 35 who were not randomized, 18 did not meet inclusion criteria and 17 did not show up.
84 young adults (18-20 years) were screened for eligibility between November 7, 2022 and June 12, 2023 through Snapchat and referrals from previous participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
| FG001 | Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Hours) |
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| 30 Minutes Break |
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| Second Intervention (2 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
| 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 | Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition | The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100. | After each of the two puff bouts, we evaluated participants' reference for the overall experience of the e-cigarette using the LHS, which is a bipolar category ratio scale that spans from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' positioned as the midpoint. The scale labels were places along the scale based on their semantic magnitude. | Posted | Least Squares Mean | Standard Error | score on a scale | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
Two hours during a single lab session
Two mild levels of adverse events were observed. The adverse event definition aligns with the definitions on ClinicalTrials.gov.
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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 | Sweet Non-menthol With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They received Durasmoke watermelon (50:50 PG/VG base) e-liquid. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suchitra Krishnan-Sarin | Yale University | (203)974-7595 | suchitra.krishnan-sarin@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 | Apr 12, 2023 | Jun 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2023 | Jun 11, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
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Flavor and nicotine concentration is blinded to participant. Research staff and investigators are blinded to flavor order administer to participants.
| Nicotine | Drug | Nicotine level (36 mg/ml) |
|
|
| Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition | Difference in irritation at each e-cigarette condition 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). | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
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| NOT COMPLETED |
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| BG001 | Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Currently enrolled in a degree program | Count of Participants | Participants |
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| Grade | Count of Participants | Participants |
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| Preferred e-cigarette device | Count of Participants | Participants |
|
| Preferred e-cigarette nicotine level | Count of Participants | Participants |
|
| Ever vaped cooling flavor | Count of Participants | Participants |
|
| Past-month other tobacco use | Count of Participants | Participants |
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| Past-month vaped THC | Count of Participants | Participants |
|
| Vaping age of onset | Mean | Standard Deviation | years |
|
| Vaping frequency | Mean | Standard Deviation | days per week |
|
| ID | Title | Description |
|---|
| OG000 | Sweet Non-menthol, Nicotine 36mg/ml | Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
| OG001 | Sweet Menthol, Nicotine 36mg/ml | Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) |
|
|
|
| Primary | Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition | Difference between e-cigarette effects for each e-cigarette condition 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). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects). | To examine wanting/liking, we used subscales from the Drug Effects Questionnaire (DEQ), following the approach established in previous literature. Four items were used to measure wanting/liking effects (the average of 'I feel good e-cigarette effects', 'I want more of that e-cigarette I received', 'I feel the e-cigarette strength', and 'I like the e-cigarette effect'). | Posted | Least Squares Mean | Standard Error | score on a scale | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
|
|
|
|
| Primary | Craving: Change in Craving Score for E-cigarette | Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes 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 | Least Squares Mean | Standard Error | score on a scale | At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
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| Primary | Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition | Difference in irritation at each e-cigarette condition 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 | Least Squares Mean | Standard Error | score on a scale | Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40) |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Sweet Menthol With Nicotine 36mg/ml | Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. Flavoring Agents: Flavor of e-liquid - sweet or tobacco Nicotine: Nicotine level (36 mg/ml) | 0 | 42 | 0 | 42 | 2 | 42 |
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| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |