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Innovative Statistical Methods for Detecting and Accounting for Non-Compliance in Randomized Trials of Very Low Nicotine Content Cigarettes

Principal Investigator: Joseph Koopmeiners and David Vock

Funding Mechanism: National Institutes of Health-Grant

ID number: 1R03DA041870-01

Award Date: 3/23/2016

Institution: University of Minnesota

Recent clinical trials on very low nicotine content (VLNC) cigarettes have examined whether reducing the nicotine content of cigarettes changes product use behavior (e.g., reducing cigarette consumption) by making cigarettes less reinforcing. However, these studies reported substantial non-compliance (i.e., smoking cigarettes other than those provided by the study). This is problematic because measures of product use behavior for these subjects are likely to be different than if they had only smoked the VLNC cigarettes assigned by the study. The goal of this project is to develop statistical methods for identifying and accounting for non-compliance in randomized trials of VLNC cigarettes and apply them to data collected by the Center for the Evaluation of Nicotine in Cigarettes (CENIC). Study aims are: (1) to develop statistical methods for estimating the probability that a subject was compliant based on his/her levels of nicotine exposure biomarkers, and (2) to develop a statistical framework for estimating the causal effect of VLNC use when noncompliance is not measured precisely. The development of these methods will result in estimates of the effects of VLNC cigarettes while accounting for the error associated with using biomarkers to identify non-compliance.