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Tobacco products come in a variety of forms that are used in different ways. They are available as skin patches, chewing gum, nasal and oral sprays, inhalers, lozenges and tablets. 

The nicotine may be delivered using electronic nicotine delivery systems (ENDS). These are some of the terms used to describe electronic nicotine delivery systems (ENDS):  Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e-pipes are some of the many tobacco product terms used to describe electronic nicotine delivery systems (ENDS).   These products use an “e-liquid” that usually contains nicotine derived from tobacco, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated to create an aerosol that the user inhales.

Self-reporting of nicotine exposure often may be biased and lead to inaccurate measures of exposure. Hence, biomarkers are often used to provide objective measures of nicotine exposure. Studies on tobacco products typically collect the quantities of the tobacco product used through self-reporting, while the actual nicotine exposure is measured by biomarkers. 

Studies may be performed under controlled circumstances in clinics. In these studies, subjects may use the study tobacco product of interest ad-librium, or as specified in the protocol.  evaluate the protocol-specified study product exposure. These products are typically supplied by the sponsor. However, sponosr may also collect exposure to other nicotine sources.      

The In tobacco studies, the subject's normal nicotine product usage (e.g., usually brand of cigarettes, nicotine replacement patches) may be allowed, or discouraged in the study.  These products are not supplied by the sponsor, and are not considered a study product. The use of these products would be represented in the SU ( for cigarettes and CM (for nicotine replacements patches) domains.     

Studies may be performed under controlled circumstances in clinics, to ensure that the only nicotine exposure is the product itself.     

Data Exposure data on the study product of interest are reported in the Exposure as Collected (EC) and/or the Exposure (EX) domains as well as the Product Accountability Domain (DA). The DA domain represents details on the amount of study product dispensed and returned.  

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1. 1. Derived from actual observation of the administration of drug of  study product by the investigator
   2. Derived from an automated dispensing device that records administrations
   3. Derived from subject recall
   4. Derived from product accountability data
   5. Derived from the protocol. When a study is still masked and protocol-specified study product exposure cannot yet be reflected in the protocol-specified unit due to blinding requirements, then the EX domain is not expected to be populated. 

The example below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources.   

In the following example, the sponsor reported protocol described usage of a nicotine inhaler using the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) were represented in the SU domain. Additionally, any usage of nicotine patches to reduce dependency on tobacco were reported in the CM domain. Study product exposure was represented as the number of cartridges used. The pharmaceutical strength of each cartridge was represented. 

In this example, the EC domain is not used by the sposnor to represent collected exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges. 

In this example, both the EC and EX domains are used.  Exposure was based on the weight of the e-nicotine liquid cartridges. 

In this example, subjects were exposed to mulitple study products. The actual dates and times of use for each product is represented.