Nicotine Vapor Specific Sensory Measurement

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Nicotine Vapor Specific Sensory Measurement

Conditions
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Substance-Related Disorder

Intervention / Treatment
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* Other: Measurement
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current daily vapers of products containing nicotine No concurrent use of other tobacco products Self reported general good health No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures No self-reported taste or smell deficits Not pregnant or lactating No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc) Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests Access to video-conference or telephone Ability to store test products in a secure location away from children Exclusion Criteria: Not current daily vapers Concurrent use of other tobacco products Self-reported fair or poor general health Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures Self-reported taste or smell deficits Pregnant or lactating Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc) Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests No access to video-conference or telephone Unable to store test products in a secure location away from children Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Adults unable to consent Adults unable to legally purchase tobacco products in New York (NY) state (18-20)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm I (3 video or telephone conferences)<br>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). | Other: Measurement<br>* Undergo sensory measurements<br>* Other names: {Measure};Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Arm II (2 video or telephone conferences)<br>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). | Other: Measurement<br>* Undergo sensory measurements<br>* Other names: {Measure};Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |