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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05876091
Other study ID # I 3234822
Secondary ID U54CA228110
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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