Clinical trial NCT04358315: Consumer Assessment of Tobacco Flavor and Odor
Official title: Consumer Assessment of Tobacco Flavor and Odor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Current Vaper
Healthy Subject
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Rochester
First posted: 2020-04-24
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current daily vapers and nonusers in the greater Buffalo and Rochester areas

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Flavor identification and evaluation
timeFrame: Up to 12 months
measure: Specific flavor detection thresholds
timeFrame: Up to 12 months
measure: Flavor combination thresholds
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Richard J O'Connor
role: PRINCIPAL_INVESTIGATOR
References: