Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Status: | Completed |
---|---|
Conditions: | Smoking Cessation, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | November 2011 |
End Date: | January 2015 |
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
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 characterize the neuropsychiatric safety profile (pre-specified
adverse events (AEs) in both of these populations).
cessation treatment in subjects with and without an established diagnosis of major
psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified
adverse events (AEs) in both of these populations).
Inclusion Criteria:
- 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 Criteria:
- 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)
We found this trial at
80
sites
Los Angeles, California 90095
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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Aurora, Colorado 80045
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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New Brunswick, New Jersey 08854
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Princeton, New Jersey 08540
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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