Clinical trial NCT04533542: Nicotine Vapor Specific Sensory Measurement
Official title: Nicotine Vapor Specific Sensory Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance-Related Disorder
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-08-31
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from general population in the greater Buffalo area and are current daily vapers

Brief summary: 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Sensory response measures
timeFrame: 2 years
measure: Sensory response measure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Richard J O'Connor
role: PRINCIPAL_INVESTIGATOR
References: