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OpenTrials
Completed

NCT Number: NCT04533542

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Measurement

Other

Undergo sensory measurements

Other names: Measure, {Measure}

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Sensory response measures

    Time frame: 2 years

    Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely

  2. Sensory response measure

    Time frame: 2 years

    gMLS rating of harshness, throat hit, and pleasantness.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2020
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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