Consumer Assessment of Tobacco Flavor and Odor

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subject; Current Vaper
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Behavioral Intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Contact: Richard J. O'Connor; Phone Number: 716-845-4517; Email: Richard.OConnor@roswellpark.org
      • Principal Investigator: Richard J. O'Connor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (smell or puff e-liquids); All panel participants smell and user panelists puff flavored e-liquids and answer questions about the products.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Behavioral Intervention; Smell or puff e-liquids; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; behavior modification

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); University of Rochester
• Investigators: Principal Investigator: Richard J O'Connor, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): October 3, 2027
• Study Completion (Estimated): October 3, 2027

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: I 80518 (Other Identifier: Roswell Park Cancer Institute); U54CA228110 (U.S. NIH Grant/Contract); NCI-2019-06320 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No