Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking) for Tobacco-Related Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Tobacco-Related Carcinoma
Tobacco Smoking - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This clinical trial evaluates how the content of waterpipe (WP) tobacco affects . The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Tobacco-Related Carcinoma

Study Objectives

16 Primary · 0 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Change in Exhaled breath carbon monoxide (CO)
Change in FEV1/FVC; The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Change in Forced expiratory flow at 25-75% of FVC
Change in Forced expiratory volume in 1 second (FEV1)
Change in Forced vital capacity (FVC)
Change in Nicotine withdrawal assessment
Change in Peak expiratory flow (PEF)
Change in Plasma nicotine boost
Change in Subjective effects of smoking tobacco
General harm and specific health risk perceptions
Nicotine dependence
Puffing topography
Subjective effects of smoking tobacco
Tobacco flavors perception, degree of liking or disliking
Tobacco flavors perception, intensity of sweetness
Tobacco use history

Trial Safety

Safety Progress

1 of 3

Other trials for Tobacco-Related Carcinoma

Trial Design

4 Treatment Groups

Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking)
1 of 4
Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking)
1 of 4
Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking)
1 of 4
Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)
1 of 4
Experimental Treatment

56 Total Participants · 4 Treatment Groups

Primary Treatment: Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking) · No Placebo Group · N/A

Tobacco flavor preparation; High Sweetness, Medium Humectant (tobacco smoking)Experimental Group · 2 Interventions: Tobacco Smoking, Questionnaire Administration · Intervention Types: Behavioral, Other
Tobacco flavor preparation; Medium Sweetness, High Humectant (tobacco smoking)Experimental Group · 2 Interventions: Tobacco Smoking, Questionnaire Administration · Intervention Types: Behavioral, Other
Tobacco flavor preparation; High Sweetness, High Humectant (tobacco smoking)Experimental Group · 2 Interventions: Tobacco Smoking, Questionnaire Administration · Intervention Types: Behavioral, Other
Tobacco flavor preparation; Medium Sweetness, Medium Humectant (tobacco smoking)Experimental Group · 2 Interventions: Tobacco Smoking, Questionnaire Administration · Intervention Types: Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobacco Smoking
2019
N/A
~1310

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Trial Background

Prof. Marielle Brinkman, Research Professor
Principal Investigator
Ohio State University Comprehensive Cancer Center
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus  1Photo of Columbus  2Photo of Columbus  3
2011First Recorded Clinical Trial
4 TrialsResearching Tobacco-Related Carcinoma
202 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You understand the study procedures and the risks and benefits of participating in the study.
You have smoked a WP at least 3 times per month in the last month.
You are willing/able to abstain from nicotine product use for at least 12 hours prior to the laboratory visits.
You are willing to attend four laboratory sessions at the same time of day.
You must be able to read and speak English.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.