Conditions: Smoking Cessation Depression
Keywords: smoking smoking cessation smoking cessation in depressed subjects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 525
Healthy volunteers: no

Brief summary:
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.

Detailed description:

Arms:
arm 1: None arm 2: placebo

Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks intervention 2: placebo tablets matched in appearance and dosage to varenicline tablets

Protocol document: