The effects of reduced nicotine content cigarettes in smokers with mood or anxiety disorders: a double-blind randomized trial

ABSTRACT BACKGROUND The U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the likely effects of this regulation in smokers with affective disorders. METHODS In a randomized controlled trial conducted at two sites (Penn State Hershey and Massachusetts General Hospital , Boston) 188 adult smokers with a current or lifetime anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) cigarettes, or Reduced Nicotine Content (RNC) cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. RESULTS After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, the RNC group had significantly lower plasma cotinine (metabolite of nicotine), urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence. There were no significant effects on psychiatric symptoms. At the end of the 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking (18% RNC v 4% UNC, p=0.004). CONCLUSION Reducing nicotine content in cigarettes to very low levels reduces toxicant exposure and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health.