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

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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).


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)
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