Nicotine Vapor Specific Sensory Measurement

Completed

• Conditions: Substance-Related Disorder
• Interventions: Other: Measurement; Other: Questionnaire Administration

• Registration Number: NCT04533542
• Lead Sponsor: Roswell Park Cancer Institute

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).

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-08-31
• Study Start: 2021-03-10
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I (3 video or telephone conferences)	Questionnaire Administration	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).
Arm II (2 video or telephone conferences)	Questionnaire Administration	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).
Arm I (3 video or telephone conferences)	Measurement	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).
Arm II (2 video or telephone conferences)	Measurement	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States