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Very-Low Nicotine Cigarettes and Non-Daily Smokers

Smoking Clinical Trial

Official title:
The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers

Clinical Trial Summary

The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

Clinical Trial Description

The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02228824
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date June 2015
Completion date July 31, 2017
View Details
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