- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533542
Nicotine Vapor Specific Sensory Measurement
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arm I (3 video or telephone conferences)
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).
|
Ancillary studies
Undergo sensory measurements
Other Names:
|
Arm II (2 video or telephone conferences)
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).
|
Ancillary studies
Undergo sensory measurements
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory response measures
Time Frame: 2 years
|
Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely
|
2 years
|
Sensory response measure
Time Frame: 2 years
|
gMLS rating of harshness, throat hit, and pleasantness.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 471719 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2019-06972 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U54CA238110 (Other Grant/Funding Number: National Institute of Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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