Este estudio se lleva a cabo para evaluar la vareniclina y el bupropión como ayudas para el tratamiento de cesación tabáquica en sujetos con y sin un diagnóstico establecido de trastorno psiquiátrico mayor, y para caracterizar el perfil de seguridad neuropsiquiátrica (eventos adversos (EA) preespecificados en ambas poblaciones).
Triple dummy placebo for each treatment arm
Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks
Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).
Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Ciudad Autonoma de Bs. As, Buenos Aires, Argentina
Mataderos, Buenos Aires, Argentina