A latest $3.9 million grant from the U.S. Food and Drug Administration (FDA) will allow researchers with the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center to guage effects of e-cigarette flavors on the smoking behaviors of current adult smokers.

The study, co-led by Theodore Wagener, PhD, director of Ohio State’s Center for Tobacco Research, and Tracy Smith, PhD, of the Medical University of South Carolina (MUSC) Hollings Cancer Center, will likely be the primary to supply definitive information concerning the impact of non-tobacco e-cigarette flavors for helping adult smokers quit smoking.

Wagener says this study will provide scientific data which might be urgently needed to tell the FDA’s regulation of flavor use in e-cigarettes.

Youth advocates have strenuously objected to flavored e-cigarettes, arguing that, with flavors like cinnamon bun, cotton candy, bubble gum, mango, strawberry or chocolate, e-cigarettes are enticing young people to take up an addictive and harmful habit. Those flavors may additionally be more appealing to adults who smoke cigarettes and have been unable to quit.

The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data. Existing data show that smokers also prefer flavored e-cigarettes, and while there are a couple of survey studies suggesting that flavored e-cigarettes could also be more helpful for switching to vaping, these studies are usually not rigorous enough for the FDA to base its regulatory decisions on. Our study will likely be the primary to supply the FDA with definitive information as to the profit, if any, of e-cigarette flavors to adult smokers.”

Theodore Wagener, PhD, Director of Ohio State’s Center for Tobacco Research

While the National Academies of Science, Engineering and Medicine have concluded that e-cigarettes are prone to be far less harmful than flamable cigarettes, Wagener notes that greater than 1 million e-cigarette products have been banned since 2020, mostly attributable to the numerous rise in youth vaping, often with flavored e-cigarettes.

Switching to e-cigarettes, while not a very healthy selection, is considered higher than continuing to smoke, an idea that public health scientists check with as “harm reduction.”

Wagener says “the FDA must determine learn how to balance its goals of protecting young people and offering harm-reduction options to adults. This latest trial will generate critical data to assist make more informed public health decisions which have an enduring impact.”.

Latest study evaluates how much flavoring impacts smoking behavior

This national, randomized, controlled trial will recruit as much as 1,500 cigarette users from the across the US.

Researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior, including sustained and complete switching from cigarettes to e-cigarettes. They may also utilize combination nicotine substitute therapy (NRT, patch and lozenge) as an FDA-approved comparator to find out the potential increased profit (or not) of e-cigarettes versus nicotine substitute therapies on smoking. Smokers will likely be randomized to one in all three groups: preferred flavor e-cigarette, tobacco flavor e-cigarette or combination nicotine substitute therapy.

Study participants will receive products for free of charge for 14 weeks. Participants in the popular flavor group will give you the option to vary flavors throughout that point. Changes in smoking will likely be biochemically confirmed via distant exhaled carbon monoxide readings at 12 weeks and 26 weeks after the product switch date.

“If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of those products is probably going indefensible; nevertheless, if improvements are significant, these findings will provide a critical counterweight to the present FDA regulations and can aid future decision making,” Wagener said.

Source:

Ohio State University Wexner Medical Center