Status:
COMPLETED
Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Lead Sponsor:
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
- Any unstable medical condition
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00749944
Start Date
September 1 2008
End Date
August 1 2009
Last Update
August 31 2010
Active Locations (2)
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1
Pfizer Investigational Site
Austin, Texas, United States, 78759
2
Pfizer Investigational Site
San Antonio, Texas, United States, 78217