Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01)

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The purpose of this Funding Opportunity Announcement (FOA) is to accelerate research evaluating electronic cigarettes (e-cigarettes, electronic nicotine delivery systems, ENDS) as a potential means of reducing the risks associated with combustible tobacco use. This goal will be achieved by funding clinical studies that use the newly-developed NIDA Standard Research E-cigarette (SREC) to examine potential risks and benefits associated with e-cigarette use in current tobacco smokers. Ultimately, this FOA aims to evaluate whether e-cigarettes can reduce the risks associated with combustible tobacco use and to establish the NIDA SREC as a standard to which other e-cigarettes can be compared. Studies submitted to this FOA should examine the effects of the SREC on multiple behavioral and health biomarkers in current tobacco smokers and may include examination of whether e-cigarettes can reduce the negative health impacts of conventional tobacco use, and / or examine their effects on craving and dependence. Funding will be contingent upon the FDA Center for Tobacco Products (CTP) determination that the studies fall under their regulatory jurisdiction. Furthermore, funding will require that CTP accepts the use of the NIDA SREC as an Investigational Tobacco Product (ITP) in the proposed study, or determines that an ITP is not required. Studies funded by this FOA are expected to rapidly increase understanding of whether e-cigarettes reduce the risks associated with tobacco use. Additionally, these studies may provide significant data to inform e-cigarette public health policy decision-making.

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