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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 : May 14, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 16, 2023
First Posted Date  ICMJE May 25, 2023
Last Update Posted Date May 14, 2024
Actual Study Start Date  ICMJE August 30, 2023
Estimated Primary Completion Date August 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2023)		 Puff Topography [ Time Frame: Up to 3 months ]
Measure of vaping topography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2023)		 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Official Title  ICMJE Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tobacco-Related Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Other: Vaping
  • Procedure: Biospecimen Collection
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2023)		 72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2026
Estimated Primary Completion Date August 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Ability to speak, read, and write in English
  • 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 10 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Richard O'Connor 716-845-4517 richard.O'Connor@roswellpark.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05876091
Other Study ID Numbers  ICMJE I 3234822
U54CA228110 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Roswell Park Cancer Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Roswell Park Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Richard O'Connor Roswell Park
PRS Account Roswell Park Cancer Institute
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP