Conditions: Nicotine Dependence Smoking Cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 345
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers

Detailed description:

Arms:
arm 1: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) arm 2: One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) arm 3: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) arm 4: One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)

Interventions: intervention 1: EVP-6124 intervention 2: Placebo Capsule intervention 3: NicoDerm Patch (Active) intervention 4: NRT Patch (Placebo) intervention 5: Brief Supportive and Behavioral Treatment
Intervention descriptions: intervention 1: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) intervention 2: One placebo capsule ingested orally daily for 12 weeks (84 days) intervention 3: One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). intervention 4: One NRT patch (Placebo) daily for first 6 weeks (42 days). intervention 5: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Protocol document: