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Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05876091
Recruitment Status : Recruiting
First Posted : May 25, 2023
Last Update Posted : January 31, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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Brief Summary:
This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.

Condition or disease Intervention/treatment Phase
Tobacco-Related Carcinoma Other: Vaping Procedure: Biospecimen Collection Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVE:

I. Examine the influence of tobacco flavoring composition on vaping topography. II. Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

SECONDARY OBJECTIVE:

I. Examine the influence of tobacco flavoring composition on vaping topography. II. Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

OUTLINE:

The order of directed and ad libitum bouts are randomized within participants at each session.

SESSION 1: Participants puff their own brand liquid on study.

SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.

SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.

Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : August 30, 2026
Estimated Study Completion Date : August 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaping -

Description The order of directed and ad libitum bouts are randomized within participants at each session.

SESSION 1: Participants puff their own brand liquid on study.

SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.

SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.

Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

 Other: Vaping
Undergo vape puffing regimen
Other Name: Vape, Vaping

Procedure: Biospecimen Collection
Undergo collection of saliva samples and oral cell samples
Other Name: Biological Sample Collection

Other: Questionnaire Administration
Administer Quesitonnaire


Outcome Measures
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Primary Outcome Measures :
  1. Puff Topography [ Time Frame: Up to 3 months ]
    Measure of vaping topography


Secondary Outcome Measures :
  1. Subjective questionnaires of product evaluation [ Time Frame: Up to 3 months ]
    Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point LIkert scale )not at all to extremely)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current daily vapers of products containing nicotine
  • No daily concurrent use of other tobacco products
  • Self-reported general good health
  • Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
  • Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
  • Self-reported taste or smell deficits
  • Pregnant or nursing female participants
  • Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
  • Unwilling to use open system vaping device in laboratory setting
  • Positive diagnosis of human coronavirus 2019 infection (COVID-19) within 30 days prior to start of study intervention
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05876091


Contacts
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Contact: Richard O'Connor 716-845-4517 richard.O'Connor@roswellpark.org

Locations
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United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Richard O"Connor    877-275-7724    askroswell@roswellpark.org   
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Richard O'Connor Roswell Park
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT05876091    
Other Study ID Numbers: I 3234822
U54CA228110 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes