Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers

The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.

Inclusion Criteria:

• Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

• Patients who have taken an investigational drug within the past six months prior to the screening visit.

• Patients who had a previous quit attempt (= or >1 day with the aid of pharmacological adjunct) in the previous three months (before screening).

• Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.

• Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]):

  • Psychotic disorder
  • Major depressive episode

• Pregnant or breast-feeding women.

• Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.

• Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.

• Patients who have a history of multiple allergic reactions to medications in two drug classes.

• Patients who have QTcF > 500 ms on the electrocardiogram (ECG).

• Patients with mild, moderate or severe renal impairment.

• Patients who have an abnormal laboratory test of potential clinical significance at screening.