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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Varenicline

Criteria

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