Conditions: Smoking Cessation
Keywords: nicotine withdrawal, smoking cessation, varenicline
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days) intervention 2: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)

Protocol document: