A randomized double-blind, active controlled, parallel group, multi-center phase 
II clinical trial was conducted to evaluate the efficacy of reduced-nicotine 
cigarettes as a novel smoking cessation treatment (under Investigational Device 
Exemption 69,185). The concept for a reduced-nicotine cigarette designed to 
progressively wean smokers from the smoking habit is based on research 
demonstrating that successful smoking cessation is not only dependent on 
withdrawal of nicotine, but also on weaning from the habitual sensory and 
behavioral reinforcement of smoking. Treatment consisted of Quest brand of 
cigarettes (Quest 1, 2, and 3), which respectively deliver 0.59+/-0.06, 
0.3+/-0.05, and less than 0.05 mg nicotine, either alone or in combination with 
nicotine replacement therapy (NRT). The primary endpoint was 4 weeks of 
continuous abstinence (Weeks 7-10), with additional follow-up at 3 and 6 months. 
Adult men and women smokers (N = 346), motivated to quit, were randomized to one 
of three treatment groups: Quest plus NRT (NRT pretreatment 2 weeks before, and 
NRT after the quit date), Quest plus placebo patch, or active control plus NRT 
(conventional cigarette, followed by NRT after quit date). Results showed that 
Quest plus NRT was more effective than active control plus NRT in achieving 4 
weeks of continuous abstinence (32.8% vs. 21.9%). Quest plus placebo patch 
yielded an abstinence rate similar to that of the active control plus NRT (16.4% 
vs. 21.9%). No serious adverse events were attributable to the investigational 
product. Quest plus NRT offers promise as a new smoking cessation treatment.