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NCT05876091
Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
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Summary Quick facts Who can join Endpoints Results Related trials Sources
Terminated
NA
Results posted
Last updated 22 December 2025
What this trial tests
NA trial testing Vaping in Tobacco-Related Carcinoma in 21 participants. Terminated before completion.
Timeline
30 August 2023
Primary endpoint 8 October 2024
29 October 2024
Quick facts
Lead sponsor Roswell Park Cancer Institute
Phase NA
Status Terminated
Study type INTERVENTIONAL
Allocation na
Design single group
Masking none
Primary purpose prevention
Enrollment 21
Start date 30 August 2023
Primary completion 8 October 2024
Estimated completion 29 October 2024
Sites 1 location across United States
Drugs / interventions tested
Conditions studied
Sponsor
Roswell Park Cancer Institute
Who can join
Adults 21 to 55, any sex, with Tobacco-Related Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Puff Topography: Puff Count
Primary
· Single Session, Approximately 2 hours in duration
Measure of vaping topography counting total number of puffs.
Group Value 95% CI Session 1: Own Brand Puff Count Ad Lib 13.9 ± 2.3 Session 1: Own Brand Puff Count Directed 6.4 ± 0.8 Sessions 2-5: Cowboy Vaping Liquid Puff Count Ad Lib 13.2 ± 2.2 Sessions 2-5: Cowboy Vaping Liquid Puff Count Directed 5.8 ± 0.8 Sessions 2-5: RY4 Double Vaping Liquid Puff Count Ad Lib 15.4 ± 3.1 Sessions 2-5: RY4 Double Vaping Liquid Puff Count Directed 5.9 ± 0.9 Sessions 2-5: Unflavored Vaping Liquid Puff Count Ad Lib 13.2 ± 2.2 Sessions 2-5: Unflavored Vaping Liquid Puff Count Directed 5.8 ± 0.9 Sessions 2-5: Red Oak Vaping Liquid Puff Count Ad Lib 13.0 ± 2.2 Sessions 2-5: Red Oak Vaping Liquid Puff Count Directed 6.3 ± 1.2 Session 6-7: Synthetic Nicotine Liquid Puff Count Ad Lib 14.3 ± 2.4 Session 6-7: Synthetic Nicotine Liquid Puff Count Directed 7.1 ± 0.9
Puff Topography: Puff Duration (in Seconds)
Primary
· Single Session, Approximately 2 hours in duration
Measure of vaping topography counting duration of puffs in seconds.
Group Value 95% CI Session 1: Own Brand Puff Duration Ad Lib 2.2 ± 0.3 Session 1: Own Brand Puff Duration Directed 3.5 ± 0.3 Sessions 2-5: Cowboy Vaping Liquid Puff Duration Ad Lib 2.3 ± 0.3 Sessions 2-5: Cowboy Vaping Liquid Puff Count Directed 3.1 ± 0.3 Sessions 2-5: RY4 Double Vaping Liquid Puff Count Ad Lib 2.5 ± 0.4 Sessions 2-5: RY4 Double Vaping Liquid Puff Count Directed 3.0 ± 0.3 Sessions 2-5: Unflavored Vaping Liquid Puff Count Ad Lib 2.3 ± 0.3 Sessions 2-5: Unflavored Vaping Liquid Puff Count Directed 3.2 ± 0.3 Sessions 2-5: Red Oak Vaping Liquid Puff Count Ad Lib 2.1 ± 0.2 Sessions 2-5: Red Oak Vaping Liquid Puff Count Directed 2.9 ± 0.3 Session 6-7: Synthetic Nicotine Liquid Puff Duration Ad Lib 2.4 ± 0.4 Session 6-7: Synthetic Nicotine Liquid Puff Duration Directed 3.0 ± 0.3
Puff Topography: Inter Puff Interval (IPI)
Primary
· Single Session, Approximately 2 hours in duration
Measure of vaping topography counting the interval between puffs in seconds.
Group Value 95% CI Session 1: Own Brand Inter Puff Interval Ad Lib 82.2 ± 14.0 Session 1: Own Brand Inter Puff Interval Directed 55.2 ± 6.1 Sessions 2-5: Cowboy Vaping Inter Puff Interval Ad Lib 61.4 ± 10.7 Sessions 2-5: Cowboy Vaping Liquid Inter Puff Interval Directed 58.0 ± 4.2 Sessions 2-5: RY4 Double Vaping Liquid Inter Puff Interval Ad Lib 71.6 ± 10.3 Sessions 2-5: RY4 Double Vaping Liquid Inter Puff Interval Directed 54.2 ± 3.6 Sessions 2-5: Unflavored Vaping Liquid Inter Puff Interval Ad Lib 71.6 ± 8.7 Sessions 2-5: Unflavored Vaping Liquid Inter Puff Interval Directed 56.7 ± 4.0 Sessions 2-5: Red Oak Vaping Liquid Inter Puff Interval Ad Lib 55.1 ± 8.1 Sessions 2-5: Red Oak Vaping Liquid Inter Puff Interval Directed 60.6 ± 5.4 Session 6-7: Synthetic Nicotine Liquid Inter Puff Interval Ad Lib 84.6 ± 12.0 Session 6-7: Synthetic Nicotine Liquid Inter Puff Interval Directed 59.3 ± 4.1
Puff Topography: Puff Volume
Primary
· Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the volume per puff in ml.
Group Value 95% CI Session 1: Own Brand Puff Volume Ad Lib 63.5 ± 13.2 Session 1: Own Brand Puff Volume Directed 102.2 ± 16.1 Sessions 2-5: Cowboy Vaping Liquid Puff Volume Ad Lib 66.2 ± 11.4 Sessions 2-5: Cowboy Vaping Liquid Puff Volume Directed 81.4 ± 14.7 Sessions 2-5: RY4 Double Vaping Liquid Puff Volume Ad Lib 83.6 ± 17.2 Sessions 2-5: RY4 Double Vaping Liquid Puff Volume Directed 103.1 ± 18.6 Sessions 2-5: Unflavored Vaping Liquid Puff Volume Ad Lib 63.9 ± 8.1 Sessions 2-5: Unflavored Vaping Liquid Puff Volume Directed 88.3 ± 13.5 Sessions 2-5: Red Oak Vaping Liquid Puff Volume Ad Lib 57.5 ± 6.5 Sessions 2-5: Red Oak Vaping Liquid Puff Volume Directed 74.9 ± 10.61 Session 6-7: Synthetic Nicotine Liquid Puff Volume Ad Lib 86.7 ± 14.9 Session 6-7: Synthetic Nicotine Liquid Puff Volume Directed 96.3 ± 13.5
Puff Topography: Flow Rate
Primary
· Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the rate of flow per puff in milliliters per second.
Group Value 95% CI Session 1: Own Brand Flow Rate Ad Lib 28.4 ± 3.4 Session 1: Own Brand Flow Rate Directed 28.7 ± 3.3 Sessions 2-5: Cowboy Vaping Liquid Flow Rate Ad Lib 28.2 ± 2.3 Sessions 2-5: Cowboy Vaping Liquid Flow Rate Directed 25.5 ± 2.7 Sessions 2-5: RY4 Double Vaping Liquid Flow Rate Ad Lib 29.3 ± 2.4 Sessions 2-5: RY4 Double Vaping Liquid Flow Rate Directed 24.8 ± 2.6 Sessions 2-5: Unflavored Vaping Liquid Flow Rate Ad Lib 27.8 ± 2.9 Sessions 2-5: Unflavored Vaping Liquid Flow Rate Directed 25.2 ± 2.8 Sessions 2-5: Red Oak Vaping Liquid Flow Rate Ad Lib 27.8 ± 2.4 Sessions 2-5: Red Oak Vaping Liquid Flow Rate Directed 24.2 ± 1.9 Session 6-7: Synthetic Nicotine Liquid Flow Rate Ad Lib 33.7 ± 2.1 Session 6-7: Synthetic Nicotine Liquid Flow Rate Directed 31.4 ± 2.1
Subjective Questionnaires of Product Evaluation
Secondary
· Single Session, Approximately 2 hours in duration
Will be assessed by Duke Sensory Scale
Draw (0 "less draw" - 100 "more draw)
Group Value 95% CI Session 1: Own Brand Ad Lib 72.3 ± 7.3 Session 1: Own Brand Directed 77.0 ± 5.7 Sessions 2-5: Cowboy Vaping Liquid Ad Lib 69.7 ± 4.4 Sessions 2-5: Cowboy Vaping Liquid Directed 64.1 ± 5.6 Sessions 2-5: RY4 Double Vaping Liquid Ad Lib 61.1 ± 6.5 Sessions 2-5: RY4 Double Vaping Liquid Directed 71.6 ± 4.5 Sessions 2-5: Red Oak Vaping Liquid Ad Lib 72.9 ± 4.7 Sessions 2-5: Red Oak Vaping Liquid Directed 75.5 ± 4.2 Sessions 2-5: Unflavored Vaping Liquid Ad Lib 68.8 ± 5.0 Sessions 2-5: Unflavored Vaping Liquid Directed 72.5 ± 4.7 Sessions 6-7: Synthetic Nicotine Ad Lib 71.9 ± 5.0 Sessions 6-7: Synthetic Nicotine Directed 74.2 ± 5.3
Pleasantness (-100 "less pleasant" - +100 "more pleasant")
Group Value 95% CI Session 1: Own Brand Ad Lib 45.2 ± 12.0 Session 1: Own Brand Directed 33.2 ± 15.9 Sessions 2-5: Cowboy Vaping Liquid Ad Lib -3.2 ± 15.3 Sessions 2-5: Cowboy Vaping Liquid Directed -32.6 ± 15.5 Sessions 2-5: RY4 Double Vaping Liquid Ad Lib 3.9 ± 13.1 Sessions 2-5: RY4 Double Vaping Liquid Directed -2.5 ± 13.3 Sessions 2-5: Red Oak Vaping Liquid Ad Lib 16.4 ± 15.2 Sessions 2-5: Red Oak Vaping Liquid Directed 37.7 ± 15.7 Sessions 2-5: Unflavored Vaping Liquid Ad Lib -2.0 ± 14.8 Sessions 2-5: Unflavored Vaping Liquid Directed 22.4 ± 16.2 Sessions 6-7: Synthetic Nicotine Ad Lib 26.2 ± 11.6 Sessions 6-7: Synthetic Nicotine Directed 21.2 ± 12.9
Tingling Sensation (0 "less tingling sensation" - 100 "more tingling sensation")
Group Value 95% CI Session 1: Own Brand Ad Lib 50.2 ± 11.4 Session 1: Own Brand Directed 34.8 ± 8.6 Sessions 2-5: Cowboy Vaping Liquid Ad Lib 34.2 ± 6.6 Sessions 2-5: Cowboy Vaping Liquid Directed 44.4 ± 4.9 Sessions 2-5: RY4 Double Vaping Liquid Ad Lib 38.9 ± 6.5 Sessions 2-5: RY4 Double Vaping Liquid Directed 44.7 ± 7.8 Sessions 2-5: Red Oak Vaping Liquid Ad Lib 25.4 ± 5.3 Sessions 2-5: Red Oak Vaping Liquid Directed 45.1 ± 6.3 Sessions 2-5: Unflavored Vaping Liquid Ad Lib 36.2 ± 5.6 Sessions 2-5: Unflavored Vaping Liquid Directed 33.4 ± 5.1 Sessions 6-7: Synthetic Nicotine Ad Lib 27.8 ± 5.3 Sessions 6-7: Synthetic Nicotine Directed 29.8 ± 5.7
Product Evaluation Score: Satisfaction (1 "not at all" - 7 "extremely")
Group Value 95% CI Session 1: Own Brand Ad Lib 4.8 ± 0.4 Session 1: Own Brand Directed 4.2 ± 0.4 Sessions 2-5: Cowboy Vaping Liquid Ad Lib 2.8 ± 0.3 Sessions 2-5: Cowboy Vaping Liquid Directed 2.6 ± 0.4 Sessions 2-5: RY4 Double Vaping Liquid Ad Lib 2.7 ± 0.3 Sessions 2-5: RY4 Double Vaping Liquid Directed 3.0 ± 0.4 Sessions 2-5: Red Oak Vaping Liquid Ad Lib 3.1 ± 0.4 Sessions 2-5: Red Oak Vaping Liquid Directed 3.4 ± 0.4 Sessions 2-5: Unflavored Vaping Liquid Ad Lib 3.1 ± 0.4 Sessions 2-5: Unflavored Vaping Liquid Directed 2.9 ± 0.4 Sessions 6-7: Synthetic Nicotine Ad Lib 3.4 ± 0.3 Sessions 6-7: Synthetic Nicotine Directed 3.4 ± 0.3
Product Evaluaton Sore: Relief (1 "not at all" - 7 "extremely")
Group Value 95% CI Session 1: Own Brand Ad Lib 5.3 ± 0.4 Session 1: Own Brand Directed 4.7 ± 0.6 Sessions 2-5: Cowboy Vaping Liquid Ad Lib 3.9 ± 0.3 Sessions 2-5: Cowboy Vaping Liquid Directed 4.4 ± 0.3 Sessions 2-5: RY4 Double Vaping Liquid Ad Lib 4.0 ± 0.3 Sessions 2-5: RY4 Double Vaping Liquid Directed 4.2 ± 0.3 Sessions 2-5: Red Oak Vaping Liquid Ad Lib 4.3 ± 0.3 Sessions 2-5: Red Oak Vaping Liquid Directed 4.1 ± 0.3 Sessions 2-5: Unflavored Vaping Liquid Ad Lib 4.5 ± 0.3 Sessions 2-5: Unflavored Vaping Liquid Directed 4.5 ± 0.3 Sessions 6-7: Synthetic Nicotine Ad Lib 4.8 ± 0.3 Sessions 6-7: Synthetic Nicotine Directed 4.7 ± 0.4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT05876091 (US National Library of Medicine, public domain)
Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor : as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
Last refreshed : 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05876091.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing
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