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CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, ST 47 (also presented at TSRC 2017)

Adapting traditional human abuse liability testing to tobacco products

KONG M.; WOOD G.
Altasciences Clinical Research, Laval, QC, Canada

Under the Family Smoking Prevention and Tobacco Control Act that grants the U.S. Food and Drug Administration (FDA) with full regulatory jurisdiction over all tobacco products, companies pursuing market access of novel tobacco products, including electronic cigarettes and smokeless tobacco products, require a premarket tobacco application (PMTA). As detailed in the FDA’s draft guidance concerning PMTAs, one of the key issues that must be addressed is the risk for addiction and abuse potential. This includes the likelihood that a novel tobacco product leads non-smokers to adopt the new tobacco product and/or its effectiveness in curbing existing smokers from using combustible cigarettes. These additional regulatory demands on tobacco products draw parallels to the human abuse potential (HAP) issues that pharmaceutical companies face when developing drugs that target the central nervous system. The methods used to demonstrate HAP - for example, acute dose effect comparisons, physical dependence measures, and behavioural economic procedures, have evolved over the past few decades and are designed to estimate the liking and wanting of the product. While some experience has been gained applying some of these methods in preclinical tobacco research, there is significantly less research using laboratory based human models of tobacco use. Furthermore, the model of addiction for tobacco products is different than pharmaceuticals, due to a much higher contribution of wanting over liking to the addictiveness, requiring consideration of this in the HAP study designs. The purpose of this presentation will be to describe how some of the methods used to study HAP of drugs can be applied to tobacco products and to discuss some of the characteristics and challenges unique to tobacco.