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

Abid Kazi, Alyse Fazzi, Nicolle M. Krebs, Aimee J. Merchlinski, Brenda Kline, Susan Veldheer, John P. Richie, Jonathan Foulds, Tonya Lane, Eric C. Donny, Joshua E. Muscat

Research output: Contribution to journalArticle

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.

LanguageEnglish (US)
Pages69-74
Number of pages6
JournalContemporary Clinical Trials Communications
Volume11
DOIs
StatePublished - Sep 1 2018

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Tobacco Products
Research
Nicotine
Substance-Related Disorders
Tobacco
Randomized Controlled Trials
Research Personnel
Clinical Trials
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

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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.",
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Cigarette Management System : An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research. / Kazi, Abid; Fazzi, Alyse; Krebs, Nicolle M.; Merchlinski, Aimee J.; Kline, Brenda; Veldheer, Susan; Richie, John P.; Foulds, Jonathan; Lane, Tonya; Donny, Eric C.; Muscat, Joshua E.

In: Contemporary Clinical Trials Communications, Vol. 11, 01.09.2018, p. 69-74.

Research output: Contribution to journalArticle

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