Nicotine Vapor Specific Sensory Measurement

This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorder
• Intervention / Treatment: Other: Questionnaire Administration; Other: Measurement

Detailed Description

PRIMARY OBJECTIVE:

I. Study that flavors might be related to the phenomenon of 'indirect' toxicity.

OUTLINE: Participants are randomized to 1 of 2 conditions.

CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).

CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants from general population in the greater Buffalo area and are current daily vapers

Description

Inclusion Criteria:

• Current daily vapers of products containing nicotine
• No concurrent use of other tobacco products
• Self reported general good health
• No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
• No self-reported taste or smell deficits
• Not pregnant or lactating
• No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
• Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
• Access to video-conference or telephone
• Ability to store test products in a secure location away from children

Exclusion Criteria:

• Not current daily vapers
• Concurrent use of other tobacco products
• Self-reported fair or poor general health
• Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
• Self-reported taste or smell deficits
• Pregnant or lactating
• Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
• Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
• No access to video-conference or telephone
• Unable to store test products in a secure location away from children
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Adults unable to consent
• Adults unable to legally purchase tobacco products in New York (NY) state (18-20)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm I (3 video or telephone conferences); Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).	Other: Questionnaire Administration; Ancillary studies; Other: Measurement; Undergo sensory measurements; Other Names: Measure; {Measure}
Arm II (2 video or telephone conferences); Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).	Other: Questionnaire Administration; Ancillary studies; Other: Measurement; Undergo sensory measurements; Other Names: Measure; {Measure}

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory response measures	Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely	2 years
Sensory response measure	gMLS rating of harshness, throat hit, and pleasantness.	2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Richard J O'Connor, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: I 471719 (Other Identifier: Roswell Park Cancer Institute); NCI-2019-06972 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U54CA238110 (Other Grant/Funding Number: National Institute of Health)

Drug and device information, study documents

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