Smoking Cessation of Young Adults

Phase 1

Conditions: Healthy daily smoking young adults aged 18-26 years
MedDRA version: 14.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2012-000596-16-FI

Lead Sponsor: apland Hospital District/ Lapland Central Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

- any chronic disease with daily medication
-known allergy to study medications(varenicline,nicotine patch,nicotine gum)
-any substance and /or alcohol abuse
-gravidity or plan to become pregnant during the study period
-lactation period of women
-drop-outs are counted as current smokers

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate smoking habits, prevalence of smoking and smoking cessation in young daily smokers. ;Secondary Objective: To assess the effectiveness of different aids used in smoking cessation of the study objectives;Primary end point(s): To measure the continuous abstinence rate

Secondary Outcome Measures