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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04358315
Other study ID # I 80518
Secondary ID NCI-2019-06320I
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2023
Est. completion date October 3, 2027

Study information

Verified date April 2024
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date October 3, 2027
Est. primary completion date October 3, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral Intervention
Smell or puff e-liquids
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (3)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Cancer Institute (NCI), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Flavor identification and evaluation Subjects will be asked to identify various concentrations of flavored e-liquids Up to 12 months
Primary Specific flavor detection thresholds Subjects will rate intensity of odors of e liquids Up to 12 months
Primary Flavor combination thresholds Subjects will rate a combination of two e-liquids combined Up to 12 months
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