Cigarette smokers willing to quit MedDRA version: 8.1 Level: LLT Classification code 10057852 Term: Nicotine dependence
Conditions
Interventions
Product Code: SSR591813L
Pharmaceutical Form: Capsule, hard
CAS Number: 292634-27-6
Current Sponsor code: SSR591813L
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Outpatients - Over legal age smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to study methodology 1. Refusal or inability to give informed consent to participate in the study. 2. Level of motivation to quit less than 6 on the ten-point Likert Scale. 3. Not able to follow verbal and written instructions and to complete all aspects of the study. 4. Other participant in a household enrolled in the study. 5. Patients who have taken an investigational drug within the past six months prior to the screening visit. 6. Patients who had a previous quit attempt (=1 day, with the aid of a pharmacological adjunct) in the previous three months (before screening). 7. 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. 8. Patients who currently present with (based on DSM-IV): - Psychotic Disorder, - Major Depressive Episode. Related to dianicline 9. Pregnant or breast-feeding women. 10. 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. 11. Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening. 12. Patients who have a history of multiple allergic reactions to medications in two drug classes. 13. Patients who have QTcF = 500 ms on the ECG. 14. Patients with mild, moderate or severe renal impairment defined as: - Creatinine clearance 2 X ULN (Upper Limit of Normal range for the laboratory).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of dianicline 40 mg bid versus placebo as an aid to smoking cessation in cigarette smokers after seven weeks of treatment.;Secondary Objective: - To demonstrate the efficacy of dianicline on reduction craving for nicotine - To evaluate the clinical and biological safety and tolerability of dianicline during a 7-week treatment period - To evaluate the abstinence rate during a 19-week follow-up post treatment period;Primary end point(s): Four-week continuous abstinence from smoking (W4 to W7) reported by the patient, confirmed by CO and plasma cotinine measurements - Smoking status Through direct inquiry of the patient, using daily recording from the patient, the investigator will determine whether the patient has been continuously abstinent (or non-abstinent) from tobacco cigarette smoking since the previous scheduled visit. - Carbon Monoxide Exhaled carbon monoxide (CO) testing will be performed as a biomedical marker of smoking status. To be considered abstinent, the patient must have a level of exhaled CO = 10 ppm. Technical procedures for collection of exhaled CO will be escribed in a separate manual to be provided to the investigational sites. and (when measured) - Cotinine measurements (only assessed at D28/W4 and D49/W7) To confirm smoking status and exhaled CO results, plasma cotinine measurements will be performed. In order to be considered to be abstinent from nicotine, a patient must have plasma cotinine levels of less than or equal to 8 micrograms/L. A validated LCMS/MS method with a limit of quantification of 4 ng/ml for cotinine will be used. | — |
Countries
Belgium, Denmark, Norway, Spain, Sweden
Outcome results
None listed