Nicotine Vapor Specific Sensory Measurement

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