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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | U.S. NIH Grant/Contract | View source | |
| 1K01DA051882-01 | 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 seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette flavor | Experimental | In this arm, participants will receive two experimental e-cigarette flavors |
|
| E-cigarette nicotine form | Experimental | In this arm, participants will receive two forms of nicotine in an e-cigarette |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine form | Drug | participants will receive 36mg/ml nicotine salt and freebase nicotine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Liking of E-cigarette Overall | Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint. | up to 3 weeks |
| Changes in Liking of E-cigarette Flavor | Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint. | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gLMS: Sweetness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierce Laboratory | New Haven | Connecticut | 06519 | United States |
20 participants were initially enrolled but only 16 took part in the actual study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | The overall sample of participants that were enrolled in the study. 10 participants received E-cigarette nicotine FIRST, E-cigarette experimental flavor SECOND. 6 participants received E-cigarette experimental flavor FIRST, E-cigarette nicotine SECOND. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of the 20 participants enrolled, only 16 were randomized and participated in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes in Liking of E-cigarette Overall | Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint. | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | score on a scale | up to 3 weeks |
|
Up to 3 weeks
Participants received all levels of the intervention in the crossover design.
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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 | Nicotine Form: Nicotine Salt | Nicotine form: participants will receive 36mg/ml nicotine salt |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asti Jackson, Ph.D. | Yale School of Medicine | 475-241-4904 | asti.jackson@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 | Aug 3, 2021 | Jan 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2021 | Jan 9, 2023 | ICF_001.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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| E-cigarette experimental flavor | Other | Participants will receive menthol and tobacco flavored e-cigarettes |
|
| up to 3 weeks |
| gLMS: Coolness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | up to 3 weeks |
| gLMS: Irritation | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | up to 3 weeks |
| Number of Puffs | The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed. | up to 3 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education Level | Count of Participants | Participants |
|
| Past Year Income | Annual salary in dollars. | Count of Participants | Participants |
|
| Age first tried e-cigarette | Age in years when first tried e-cigarette. | Mean | Standard Deviation | years |
|
| Days used of e-cigarettes in past 28 days | Mean | Standard Deviation | days |
|
| e-cigarette dependence | Self-reported e-cigarette dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence. | Mean | Standard Deviation | units on a scale |
|
| Age first smoked whole cigarette | Age first smoked whole cigarette in years. | Mean | Standard Deviation | years |
|
| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes |
|
| cigarette dependence | Self-reported cigarette dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Changes in Liking of E-cigarette Flavor | Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint. | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | score on a scale | up to 3 weeks |
|
|
|
|
| Secondary | gLMS: Sweetness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | score on a scale | up to 3 weeks |
|
|
|
|
| Secondary | gLMS: Coolness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | score on a scale | up to 3 weeks |
|
|
|
|
| Secondary | gLMS: Irritation | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | score on a scale | up to 3 weeks |
|
|
|
|
| Secondary | Number of Puffs | The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed. | Participants that enrolled and participated in the overall study. | Posted | Least Squares Mean | Standard Error | number of puffs (log transformed) | up to 3 weeks |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Nicotine Form: Freebase Nicotine | Nicotine form: participants will receive freebase nicotine | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | E-cigarette Experimental Flavor: Menthol | E-cigarette experimental flavor: Participants will receive menthol flavored e-cigarettes | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | E-cigarette Experimental Flavor: Tobacco | E-cigarette experimental flavor: Participants will receive tobacco flavored e-cigarettes | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Measurements |
|---|---|
|
| Tobacco Flavor |
|
| 0.85 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Tobacco Flavor |
|
| 0.77 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Tobacco Flavor |
|
| 0.05 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Tobacco Flavor |
|
| 0.04 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Tobacco Flavor |
|
| 0.38 |
| Superiority |