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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06972 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 471719 | Other Identifier | Roswell Park Cancer Institute | |
| U54CA238110 | Other Grant/Funding Number | National Institute of Health |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.
PRIMARY OBJECTIVE:
I. Study that flavors might be related to the phenomenon of 'indirect' toxicity.
OUTLINE: Participants are randomized to 1 of 2 conditions.
CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).
CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (3 video or telephone conferences) | Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations). |
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| Arm II (2 video or telephone conferences) | Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement | Other | Undergo sensory measurements |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensory response measures | Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely | 2 years |
| Sensory response measure | gMLS rating of harshness, throat hit, and pleasantness. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants from general population in the greater Buffalo area and are current daily vapers
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| Name | Affiliation | Role |
|---|---|---|
| Richard J O'Connor | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Questionnaire Administration | Other | Ancillary studies |
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