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
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:
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)
La Jolla, California 92037, United States
Los Angeles, California 90095, United States
Aurora, Colorado 80045, United States
Indianaopolis, Indiana 46254, United States
New Brunswick, New Jersey 08901, United States
Princeton, New Jersey 08540, United States
Madison, Wisconsin 53711-2027, United States
Ciudad Autonoma de Bs. As, Buenos Aires C1426ABP, Argentina
Mataderos, Buenos Aires C1440BRR, Argentina
Porto Alegre, Rio Grande do Sul 90035-074, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Campinas, São Paulo 13059-740, Brazil
São Paulo, São Paulo 05017-000, Brazil
Troyan Municipality, 5600, Bulgaria
Colonia Hipodromo Condesa, Mexico DF 06100, Mexico
Morelia, Michoacán 58249, Mexico
Moscow, 117152, Russia
Saint Petersburg, 190121, Russia
Saint Petersburg, 192019, Russia
Smolensk, 214019, Russia
Bratislava, 851 01, Slovakia
Benoni, Johannesburg, Gauteng 1500, South Africa