Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research

Abstract

Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.

Fig. 1

The carton blind code number and the bar code (label on the left) are generated using a random number generator and a bar code generator. The bar code facilitates quick and accurate entry into the CMS. The right label goes on each of the 10 individual cigarette packs in a carton. The sides of each carton have the blind code and bar code label on them and the front has same information as the individual packs within the carton. The CMS administrator fills out the participant identifier number (PID) portion when the carton is dispensed.

Fig. 2

A screen capture of the search capability of the CMS to be able to track cartons by their carton blind code number. In addition cartons can be searched by study site, nicotine strength, flavor, and PID.