Smoking Cessation of Young Adults in Northern Finland

INTERVENTION: Trade Name: Champix Product Name: Champix Pharmaceutical Form: Tablet CAS Number: 375815‐87‐5 Other descriptive name: VARENICLINE TARTRATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0,5‐2 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Nicotinell Product Name: Nicotinell Pharmaceutical Form: Cutaneous patch INN or Proposed INN: NICOTINE S(‐) Concentration unit: mg milligram(s) Concentration type: range Concentration number: 7‐21 Pharmaceutical form of the placebo: Cutaneous patch Route of administration of the placebo: Cutaneous use Trade Name: Nicotinell Product Name: Nicotinell Mint, Nicotinell Fruit,Nicotinell Lakrits Pharmaceutical Form: Medicated chewing‐gum INN or Proposed INN: NICOTINE S(‐) Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2‐4 CONDITION: Healthy daily smoking young adults aged 18‐26 years ; MedDRA version: 14.1 Level: PT Classification code 10053325 Term: Smoking cessation therapy System Organ Class: 10042613 ‐ Surgical and medical procedures PRIMARY OUTCOME: Main Objective: To evaluate smoking habits, prevalence of smoking and smoking cessation in young daily smokers. Primary end point(s): To measure the continuous abstinence rate Secondary Objective: To assess the effectiveness of different aids used in smoking cessation of the study objectives SECONDARY OUTCOME: Secondary end point(s): To assess the abstinence by urine cotinine testing INCLUSION CRITERIA: ‐healthy daily smokers aged 18‐26 years ‐motivation to quit smoking and to attend the 12 months follow‐up ‐dailys smoker has smoked at least 1cig/day daily during the last month and has smoked at least 100 cig ever ‐a non‐smoker has not smoked during the last month and has smoked ever less than 50cig ‐minor allergies or mild asthma without daily medication is acceptable ‐healthy non‐smokers 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range