Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

Tobacco-Related Carcinoma Clinical Trial

Official title:

Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876091
• Other study ID #: I 3234822
• Secondary ID: U54CA228110
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: Richard O'Connor
• Phone: 716-845-4517
• Email: richard.O'Connor[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco-Related Carcinoma

Intervention

Other:
• Vaping
Undergo vape puffing regimen

Procedure:
• Biospecimen Collection
Undergo collection of saliva samples and oral cell samples

Other:
• Questionnaire Administration
Administer Quesitonnaire

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puff Topography	Measure of vaping topography	Up to 3 months
Secondary	Subjective questionnaires of product evaluation	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)	Up to 3 months