Consumer Assessment of Tobacco Flavor and Odor

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04358315
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 52.4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Current Vaper; Healthy Subject	Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Consumer Assessment of Tobacco Flavor and Odor
• Actual Study Start Date: Sep 19, 2019
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Flavor identification and evaluation [Up to 12 months]

   Subjects will be asked to identify various concentrations of flavored e-liquids

2. Specific flavor detection thresholds [Up to 12 months]

   Subjects will rate intensity of odors of e liquids

3. Flavor combination thresholds [Up to 12 months]

   Subjects will rate a combination of two e-liquids combined

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Richard J O'Connor, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT04358315
• Other Study ID Numbers: I 80518; NCI-2019-06320; I 80518; P30CA016056; U54CA228110
• First Posted: Apr 24, 2020
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• 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

Study Results

No Results Posted as of Jun 10, 2022