Substance-Related Disorder
Conditions
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).
Interventions
OTHERMeasurement
Undergo sensory measurements
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Institutes of Health (NIH)
Roswell Park Cancer Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory response measures | 2 years | Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely |
| Sensory response measure | 2 years | gMLS rating of harshness, throat hit, and pleasantness. |
Countries
United States
Outcome results
None listed