Status:
COMPLETED
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Lead Sponsor:
Pfizer
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to char...
Eligibility Criteria
Inclusion
- Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
- Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
- For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.
Exclusion
- Subjects with a past or current diagnosis of one of the following disorders:
- a. Psychotic Disorders:
- Schizophreniform
- Delusional Disorder
- Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
8144 Patients enrolled
Trial Details
Trial ID
NCT01456936
Start Date
November 1 2011
End Date
January 1 2015
Last Update
June 10 2016
Active Locations (156)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
NoesisPharma Research
Phoenix, Arizona, United States, 85032
3
Pharmacology Research Institute
Encino, California, United States, 91316
4
Synergy Clinical Research of Escondido
Escondido, California, United States, 92025