Palatability of Experimental Cigarettes - Study 2

Completed · Not applicable

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT01568905

Run by

University of Minnesota

People needed

36

Starts

2011-02-01

Expected to finish

2012-03-01

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-64 years old
• Regular smokers (10+ cigarettes per day and has done so for the last year)
• Inhaling when smoking
• Carbon monoxide (CO) > 8 ppm

You may not qualify if…

• In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
• Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
• Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
• Consumed more than 15 alcoholic drinks per week for the past month
• Pregnant, trying to become pregnant, or lactating (assessed by self-report)
• In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline
• Currently trying or planning to reduce or quit tobacco use in the next 30 days
• Used other forms of tobacco 10 or more days in the past 30 days

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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