Palatability of Experimental Cigarettes - Study 2

Smoking Clinical Trial

Official title: Palatability of Experimental Cigarettes

Status Completed

Clinical Trial Summary

Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.

Clinical Trial Description

Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type. ;

Related Conditions & MeSH terms

• Smoking

• NCT number: NCT01568905
• Study type: Interventional
• Source: University of Minnesota
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Completion date: March 2012