Nicotine Vapor Specific Sensory Measurement

Substance-Related Disorder Clinical Trial

Official title:

Nicotine Vapor Specific Sensory Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533542
• Other study ID #: I 471719
• Secondary ID: NCI-2019-06972I
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: March 7, 2023

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Substance-Related Disorder
• Substance-Related Disorders

Intervention

Other:
• Measurement
Undergo sensory measurements
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory response measures	Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely	2 years
Primary	Sensory response measure	gMLS rating of harshness, throat hit, and pleasantness.	2 years