Friday, July 31, 2015
Virginia Commonwealth University Massey Cancer Center researchers at the VCU Center for the Study of Tobacco Products (CSTP) have developed the first-ever, evidence-based model that can predict with up to 90 percent accuracy the amount of nicotine emitted by an electronic cigarette. The study was published in the journal Nicotine and Tobacco Research.
The researchers, working in collaboration with investigators at the American University of Beirut, collected data about the voltage and other characteristics of various e-cigarette devices, the concentration of the liquid nicotine that could be put in the devices, and the length of time a user might inhale from the device in one puff. The team then developed a mathematical model to determine how much nicotine was emitted from the devices as the device voltage and the nicotine liquid concentration were increased and the user puff duration was extended. The model predicted that higher voltage e-cigarette devices paired with high-concentration nicotine liquids could emit greater levels of the addictive substance than those of a traditional tobacco cigarette, depending on user puff duration.
Laboratory results showed that nicotine yields from 15 puffs on an e-cigarette varied by more than 50 times across various device, liquid and user behavior conditions.
“Laboratory results showed that nicotine yields from 15 puffs on an e-cigarette varied by more than 50 times across various device, liquid and user behavior conditions,” said the research team member Thomas Eissenberg, Ph.D., professor in the VCU Department of Psychology in the College of Humanities and Sciences, director of the CSTP and a member of the Cancer Prevention and Control research program at Massey.
In a subsequent clinical study conducted at VCU, the researchers also observed that experienced e-cigarette users were more likely to take longer puffs than novice users, resulting in higher levels of nicotine being delivered to their bloodstream.
According to Eissenberg, these findings indicate that without federal regulation on these devices users could become more addicted to nicotine from e-cigarette use than from smoking a conventional combustible cigarette.
“When used as intended, an electronic cigarette should not produce a nicotine yield in excess of that of a combustible cigarette, a device that we already know has lethal health effects,” Eissenberg said. “If it does, then we are essentially making an already addictive drug delivery system even more addictive.”
Tobacco use remains the leading cause of preventable cancer incidence in the U.S., with the general assumption that e-cigarettes are a “safer” alternative as a nicotine delivery method. This could be true, Eissenberg stated, as long as the e-cigarette device and its liquid are not designed in a way that would deliver excessive levels of the addictive substance or other dangerous chemicals to the user. However, restrictions dictating safer design may only occur through federal regulation since product developers may not be inclined to self-impose such regulations.
With this novel nicotine mathematical model, researchers will now be able to predict with a great deal of accuracy how much nicotine will be delivered to an e-cigarette user before a device is even designed. These predictions will further enable researchers like Eissenberg and his colleagues to inform federal regulators about evidence-based recommendations on e-cigarette design restrictions that could potentially avoid a serious public health disaster as more people turn to e-cigarettes as an alternative nicotine delivery method.
This model also sets the framework for a clinical trial that has just opened at the VCU CSTP as well as Penn State University’s Tobacco Center of Regulatory Science in Hershey, Pennsylvania, that will evaluate novel tobacco products, including e-cigarettes, on health indicators and cigarette smoking behavior in people who are currently smoking tobacco cigarettes and who are interested in reducing their cigarette use.
Eissenberg collaborated to develop the aerosol nicotine exposure model with lead author Alan Shihadeh, Sc.D., director of Project 1, Analytic Lab Methods for Modified Risk Tobacco Product Evaluation (MRTP), member of the executive leadership committee at the VCU CSTP and professor of mechanical engineering at the American University of Beirut (AUB); Soha Talih, Ph.D., research scientist at the VCU CSTP and research scientist at the Department of Mechanical Engineering at the AUB; Rola Salman, analytical chemist at the VCU CSTP and manager of the Aerosol Research Lab at the AUB; Zainab Balhas, member of the Project 1 team at the VCU CSTP and graduate student in the Department of Mechanical Engineering at the AUB; Nareg Karaoghlanian, member of the investigative team of Project 1 at the VCU CSTP and research engineer at the AUB Department of Mechanical Engineering; Ahmad El Hellani, Ph.D., member of the investigative team of Project 1 at the VCU CSTP and postdoctoral associate in the Departments of Chemistry and Mechanical Engineering at AUB; Rima Baalbaki, research assistant at the VCU CSTP and in the Department of Engineering at the AUB; and Najat Saliba, Ph.D., professor of chemistry at the AUB.
Funding for this research was supported by the National Institute on Drug Abuse of the National Institutes of Health grant P50 DA036105, the Center for Tobacco Products of the U.S. Food and Drug Administration and, in part, by VCU Massey Cancer Center’s NIH-NCI Cancer Center Support Grant P30 CA016059.
The VCU Center for the Study of Tobacco Products is a World Health Organization Collaborating Center. As such, they will disseminate novel methods for evaluating tobacco products, provide research results and support evaluation of e-cigarettes, train scientists in methods to evaluate non-cigarette tobacco products, and prepare related briefing and education materials.
The clinical trial is now open for recruitment and will be conducted in collaboration with the Pennsylvania State Hershey Medical Center. The study locations are Richmond, Virginia, and Hershey, Pennsylvania.
Those interested in enrolling or learning more about this clinical trial should contact the VCU Center for the Study of Tobacco Products at 804-628-7550 or https://cstp.vcu.edu/rct and reference clinical trial NCT02342795.
The full manuscript of this study is available online at: http://ntr.oxfordjournals.org/content/17/2/150.full?sid=80e17d27-d270-4928-a4b9-3a27a6e885fb.
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