Conditions: Smoking Cessation
Keywords: smoking cessation psychiatric disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8144
Healthy volunteers: yes

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 characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

Detailed description:

Arms:
arm 1: Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive. arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Placebo intervention 2: varenicline tartrate intervention 3: bupropion hydrochloride intervention 4: Nicotine Replacement Therapy Patch
Intervention descriptions: intervention 1: Triple dummy placebo for each treatment arm intervention 2: 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 intervention 3: 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). intervention 4: 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.

Protocol document: