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VCU TCORS: Randomized Control Trial Methods for MRTP Evaluation

Principal Investigator: Thomas Eissenberg and Jonathan Foulds

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036105-01

Award Date: 9/30/2013

Institution: Virginia Commonwealth University

Data addressing how long-term e-cigarette use influences toxicant exposure, user health, and concurrent cigarette smoking are very limited. This project will characterize the effects of real-world e-cigarette use in the natural environment via a multi-site randomized controlled trial. Specific aims are: (1) to characterize product influence on toxicants, biomarkers, health indicators, and disease risk; (2) to determine the tobacco abstinence symptom and adverse event profile associated with real-world product use; and (3) to examine the influence of novel product use on conventional tobacco product use. Investigators will randomly assign 520 e-cigarette-naïve cigarette smokers (aged 18-59) who are interested in reducing their tobacco use to one of four conditions for six months: high-nicotine dose e-cigarette, mid-nicotine dose e-cigarette, zero nicotine dose (placebo) e-cigarette, or a control condition that includes use of a non-combustion, non-nicotine, non-vapor, imitation cigarette substitute.  Investigators will measure exposure to the carcinogenic nitrosamine NNK (via its metabolite NNAL in urine); carbon monoxide (via exhaled air); nicotine (via its metabolite cotinine in urine); heart rate; blood pressure; biochemical and hematologic health indices (e.g., lipoproteins, hemoglobin, hematocrit); pulmonary function (via spirometry); biomarkers of oxidative stress (e.g., 8-lsoprostane, glutathione, 8-OHDG); abstinence symptoms; and adverse effects (e.g., dry mouth, throat, and eyes; heart pounding; nausea).  This project will develop a randomized controlled trial model that can be used to evaluate any novel tobacco product, not just e-cigarettes.

VCU Center for the Study of Tobacco Products (TCORS) Related Resources