Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

NCT05876091 | Terminated Results

• 2 other identifiers: I 3234822U54CA228110
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (5)

• Puff Topography: Puff Count

  Measure of vaping topography counting total number of puffs.

  Single Session, Approximately 2 hours in duration

• Puff Topography: Puff Duration (in Seconds)

  Measure of vaping topography counting duration of puffs in seconds.

  Single Session, Approximately 2 hours in duration

• Puff Topography: Inter Puff Interval (IPI)

  Measure of vaping topography counting the interval between puffs in seconds.

  Single Session, Approximately 2 hours in duration

• Puff Topography: Puff Volume

  Measure of vaping topography measuring the volume per puff in ml.

  Single Session, Approximately 2 hours in duration

• Puff Topography: Flow Rate

  Measure of vaping topography measuring the rate of flow per puff in milliliters per second.

  Single Session, Approximately 2 hours in duration

Secondary Outcomes (1)

• Subjective Questionnaires of Product Evaluation

  Single Session, Approximately 2 hours in duration

Study Arms (1)

Vaping -

EXPERIMENTAL

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; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Vaping OTHER

Undergo vape puffing regimen

Also known as: Vape, Vaping

Vaping -

Biospecimen Collection PROCEDURE

Undergo collection of saliva samples and oral cell samples

Also known as: Biological Sample Collection

Vaping -

Questionnaire Administration OTHER

Administer Quesitonnaire

Vaping -

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Brian Fix
• Organization: Roswell Park Comprehensive Cancer Center

Brian.Fix@roswellpark.org

716-845-2300

Study Officials

• Richard O'Connor

  Roswell Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: August 30, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 29, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Locations

US (1)