Clinical trial NCT05876091: Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Official title: Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-25
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

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

SECONDARY OBJECTIVE:

* Examine the influence of tobacco flavoring composition on vaping topography.
* 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.

Eligibility 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
* 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

Primary outcomes:
measure: Puff Topography
timeFrame: Up to 3 months
Secondary outcomes:
measure: Subjective questionnaires of product evaluation
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park
name: Richard O'Connor
role: PRINCIPAL_INVESTIGATOR
References: