Eli Klemperer, PhD
Cigarette smoking accounts for nearly 1 in 5 cancer cases and one-third of all cancer related deaths. In recent years, the prevalence of using multiple tobacco products, notably cigarettes and e-cigarettes, has been on the rise in the U.S. While e-cigarettes offer a potentially safer alternative, most users continue to smoke cigarettes in the long term, especially those who use e-cigarettes infrequently.
To combat this issue, the Food and Drug Administration is planning to impose a nicotine-limiting standard on cigarettes, that could potentially save millions of lives over time. However, it's uncertain how this regulation will affect dual users of cigarettes and e-cigarettes.
Eli Klemperer, PhD, was recently awarded an R01 grant to study the effects of nicotine limiting standards on adult dual users in Vermont, Northern New York, and Rhode Island. While the cigarette smoking rates in the UVM Cancer Center’s catchment area vary rates in some counties are as high as 23% compared to the national average of 14%.
The grant - a combined award from the National Institute on Drug Abuse (NIDA) and the Food and Drug Administration Center for Tobacco Products - will allow Dr. Klemperer, in collaboration with Professor of Psychiatry and Vermont Center for Behavior and Health Director Stephen Higgins, Ph.D., and colleagues from the Larner College of Medicine and Brown University, to conduct a 12-week, double-blind randomized controlled trial. The primary objective of the trial is to investigate the impact of the proposed nicotine-limiting standard for cigarettes on the total number of cigarettes smoked per day among adult dual users. Additionally, the study aims to assess whether any observed changes are influenced by corresponding limitations on e-cigarette nicotine content.
For the study, participants will be randomly assigned to one of four different combinations of high- and low-nicotine e-cigarettes and cigarettes, allowing researchers to determine the most effective combination in reducing cigarette use. The investigators expect to recruit over 300 adult dual users to participate in the trial.
This grant follows a series of successful trials led by Dr. Higgins between 2016 and 2019, and subsequent work recently published in JAMA, which revealed promising results regarding the effectiveness of very low-nicotine-content (VLNC) cigarettes in reducing smoking rates and dependence severity among vulnerable populations. These findings underscore the potential of reducing nicotine content in cigarettes to facilitate smoking cessation efforts, particularly among high-risk individuals.
The team will communicate the results of the new study directly to the FDA to inform their proposed nicotine-limiting standard for cigarettes and how that policy could be impacted by e-cigarette regulation. “This work is especially relevant to the rural areas of our region. Tobacco use disproportionally effects people in rural communities. This work could inform policy around tobacco, specifically helping to reduce the tobacco health burden carried in rural communities,” said Dr. Klemperer.
Adapted from "UVM Researching Nicotine-Limiting Standard for Cigarettes and e-Cigarettes" by Christopher Pung and Angela Ferrante, MBA, MPH