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Consumer Assessment of Tobacco Flavor and Odor

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ClinicalTrials.gov Identifier: NCT04358315
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 17, 2024
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Rochester
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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
Current Vaper Healthy Subject Behavioral: Behavioral Intervention Other: Questionnaire Administration

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consumer Assessment of Tobacco Flavor and Odor
Actual Study Start Date : April 3, 2023
Estimated Primary Completion Date : October 3, 2027
Estimated Study Completion Date : October 3, 2027
Groups and Cohorts
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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.
 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
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Primary Outcome Measures :
  1. Flavor identification and evaluation [ Time Frame: Up to 12 months ]
    Subjects will be asked to identify various concentrations of flavored e-liquids

  2. Specific flavor detection thresholds [ Time Frame: Up to 12 months ]
    Subjects will rate intensity of odors of e liquids

  3. Flavor combination thresholds [ Time Frame: Up to 12 months ]
    Subjects will rate a combination of two e-liquids combined


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Current daily vapers and nonusers in the greater Buffalo and Rochester areas
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358315


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Richard J. O'Connor    716-845-4517    Richard.OConnor@roswellpark.org   
Principal Investigator: Richard J. O'Connor         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
University of Rochester
Investigators
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Principal Investigator: Richard J O'Connor Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04358315    
Other Study ID Numbers: I 80518
NCI-2019-06320 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 80518 ( Other Identifier: Roswell Park Cancer Institute )
U54CA228110 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024

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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