Consumer Assessment of Tobacco Flavor and Odor

NCT04358315 | Terminated

• 3 other identifiers: I 80518NCI-2019-06320U54CA228110
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Current Vaper; Healthy Subject

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Observational (smell or puff e-liquids)

All panel participants smell and user panelists puff flavored e-liquids and answer questions about the products.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Smell or puff e-liquids

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Observational (smell or puff e-liquids)

Questionnaire Administration OTHER

Ancillary studies

Observational (smell or puff e-liquids)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Current daily vapers and nonusers in the greater Buffalo and Rochester areas

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• University of Rochester: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard J O'Connor

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 24, 2020
• Study Start: April 3, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)