Consumer Assessment of Tobacco Flavor and Odor

Study Overview
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Brief Summary
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This trial studies consumer assessments of tobacco flavor and odor. This study will compare the ability of expert and consumer panels to identify and characterize flavors, determine threshold detection levels for individual and mixed flavors, and identify the dominant flavor of mixtures.

Detailed Description
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PRIMARY OBJECTIVE: I. Develop consumer (untrained) sensory panels to identify and assess characterizing flavors in electronic (e)-liquids. OUTLINE: Non-user panelists smell and user panelists puff flavored e-liquids and answer questions about the products.

Official Title
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Consumer Assessment of Tobacco Flavor and Odor

Conditions
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Current Vaper, Healthy Subject

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CONSUMER USER: Current daily vapers of products containing nicotine CONSUMER USER: No concurrent use of other tobacco products CONSUMER USER: General good health CONSUMER USER: No allergies CONSUMER USER: No self-reported taste or smell deficits CONSUMER USER: Not pregnant or lactating CONSUMER USER: No medications known to interfere with taste/smell CONSUMER USER: Passing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests CONSUMER USER: No positive diagnosis of COVID-19 within 30 days CONSUMER NONUSER: No use of tobacco or nicotine products in the last year CONSUMER NONUSER: General good health CONSUMER NONUSER: No allergies CONSUMER NONUSER: No self-reported taste or smell deficits CONSUMER NONUSER: Not pregnant or lactating CONSUMER NONUSER: No medications known to interfere with taste/smell CONSUMER NONUSER: Passing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests CONSUMER NONUSER: No positive diagnosis of COVID-19 within 30 days Exclusion Criteria: CONSUMER USER: Outside age range CONSUMER USER: Not current daily vapers CONSUMER USER: Concurrent use of other tobacco products CONSUMER USER: Fair or poor general health CONSUMER USER: Allergies CONSUMER USER: Self-reported taste or smell deficits CONSUMER USER: Pregnant or lactating CONSUMER USER: Medications known to interfere with taste/smell CONSUMER USER: Failing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests CONSUMER USER: Positive diagnosis of COVID-19 within 30 days CONSUMER NONUSER: Outside age range CONSUMER NONUSER: Use of tobacco or nicotine products in the last year CONSUMER NONUSER: Fair or poor general health CONSUMER NONUSER: Allergies CONSUMER NONUSER: Self-reported taste or smell deficits CONSUMER NONUSER: Pregnant or lactating CONSUMER NONUSER: Medications known to interfere with taste/smell CONSUMER NONUSER: Failing scores on the Brief Smell Identification Test (B-SIT), phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests CONSUMER NONUSER: Positive diagnosis of COVID-19 within 30 days

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Observational (smell or puff e-liquids)<br>Non-user panelists smell and user panelists puff flavored e-liquids and answer questions about the products. | Behavioral: Behavioral Intervention<br>* Smell or puff e-liquids<br>* Other names: Behavioral Treatments;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 |
| --- | --- | --- |
| Flavor identification and evaluation | Subjects will be asked to identify various concentrations of flavored e-liquids | Up to 12 months | 
| Specific flavor detection thresholds | Subjects will rate intensity of odors of e liquids | Up to 12 months | 
| Flavor combination thresholds | Subjects will rate a combination of two e-liquids combined | Up to 12 months |