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

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT00749944

Run by

Pfizer

People needed

110

Starts

2008-09-01

Expected to finish

2009-08-01

Last updated by the study team

2010-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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