Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

An Experimental Medicine, Randomized, Double-Blind Study Assessing Neuropsychiatric Symptoms In Quitting Smokers Treated With Varenicline Tartrate Or Placebo

Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Inclusion Criteria:

• smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

Exclusion Criteria:

• Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
• Any unstable medical condition