Nicotine Vapor Specific Sensory Measurement

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Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Substance-Related Disorder

Treatments

Other: Measurement
Other: Questionnaire Administration

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04533542
NCI-2019-06972 (Registry Identifier)
U54CA238110 (Other Grant/Funding Number)
I 471719 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

42 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

42 participants in 2 patient groups

Arm I (3 video or telephone conferences)
Description:
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).
Treatment:
Other: Questionnaire Administration
Other: Measurement
Arm II (2 video or telephone conferences)
Description:
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).
Treatment:
Other: Questionnaire Administration
Other: Measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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