Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
NCT ID: NCT00749944
Last Updated: 2010-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2008-09-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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varenicline
varenicline
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
placebo
placebo
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
Interventions
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varenicline
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
placebo
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any unstable medical condition
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Countries
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References
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Garza D, Murphy M, Tseng LJ, Riordan HJ, Chatterjee A. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biol Psychiatry. 2011 Jun 1;69(11):1075-82. doi: 10.1016/j.biopsych.2010.12.005. Epub 2011 Feb 3.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051115
Identifier Type: -
Identifier Source: org_study_id