Consumer Assessment of Tobacco Flavor and Odor

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

Tracking Information

• First Submitted Date: April 13, 2020
• First Posted Date: April 24, 2020
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: April 3, 2023
• Estimated Primary Completion Date: October 3, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2020)

• Flavor identification and evaluation [ Time Frame: Up to 12 months ]
  Subjects will be asked to identify various concentrations of flavored e-liquids
• Specific flavor detection thresholds [ Time Frame: Up to 12 months ]
  Subjects will rate intensity of odors of e liquids
• Flavor combination thresholds [ Time Frame: Up to 12 months ]
  Subjects will rate a combination of two e-liquids combined

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Consumer Assessment of Tobacco Flavor and Odor
• Official Title: Consumer Assessment of Tobacco Flavor and Odor
• 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Current daily vapers and nonusers in the greater Buffalo and Rochester areas

Condition

• Current Vaper
• Healthy Subject

Intervention

• 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

Study Groups/Cohorts

Observational (smell or puff e-liquids)

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

Interventions:

• Behavioral: Behavioral Intervention
• Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 20, 2020): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 3, 2027
• Estimated Primary Completion Date: October 3, 2027 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roswell Park Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Roswell Park Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

• National Cancer Institute (NCI)
• University of Rochester

Investigators

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

• PRS Account: Roswell Park Cancer Institute
• Verification Date: April 2024