Nicotine Vapor Specific Sensory Measurement

April 3, 2023 updated by: Roswell Park Cancer Institute
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.

Study Overview

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

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants from general population in the greater Buffalo area and are current daily vapers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Measure
  • {Measure}
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:
  • Measure
  • {Measure}

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

March 10, 2025

Study Completion (Anticipated)

September 10, 2025

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Substance-Related Disorder

Clinical Trials on Questionnaire Administration

3
Subscribe