Consumer Assessment of Tobacco Flavor and Odor

Healthy Subject Clinical Trial

Official title:

Consumer Assessment of Tobacco Flavor and Odor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358315
• Other study ID #: I 80518
• Secondary ID: NCI-2019-06320I
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Current Vaper
• Healthy Subject

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