Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05876091
• Collaborator: (none)
• Enrollment: 72
• Arm: 1
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco-Related Carcinoma	Other: Vaping; Procedure: Biospecimen Collection; Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

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.

Other: Vaping; Undergo vape puffing regimen; Other Names: Vape, Vaping ; Procedure: Biospecimen Collection; Undergo collection of saliva samples and oral cell samples; Other Names: Biological Sample Collection ; Other: Questionnaire Administration; Administer Quesitonnaire

Outcome Measures

Primary Outcome Measures

1. Puff Topography [Up to 3 months]

   Measure of vaping topography

Secondary Outcome Measures

1. Subjective questionnaires of product evaluation [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

• 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 30 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Roswell Park Cancer Institute

Investigators

• Principal Investigator: Richard O'Connor, Roswell Park

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT05876091
• Other Study ID Numbers: I 3234822
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• 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

Study Results

No Results Posted as of May 25, 2023