22nd Century Group Inc (XXII)

[Bubbster]

ClinicalTrials.gov Id: NCT02139930

First received: May 12, 2014
Last updated: January 19, 2016
Last verified: January 2016

The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels.

Behavioral: Normal Nicotine Control Group
Behavioral: Immediate Nicotine Reduction Group
Behavioral: Gradual Nicotine Reduction Group

Detailed Description:
This project will be conducted to compare product use patterns and biomarkers of exposure between smokers who are assigned to:
a) gradual reduction in reduced nicotine content (RNC) cigarettes;
b) immediate reduction to very low nicotine content (VLNC) cigarettes or
c) normal nicotine content (NNC) cigarettes.

The outcomes from this study will provide information on different approaches to reducing levels of nicotine in cigarettes and will determine the approach with the most optimal outcomes taking into account the balance between overall risk reduction (possibly maximized by abrupt switching) and compliance and acceptability (possibly maximized by gradual reduction of RNC cigarettes).