Smoking cessation by nurses with smokelesstobacco buccal tabltes, nicotine buccal tablets, nicotine patches with repeated thearapy every 6 months for 2 years

Conditions: Smopking (nicotine addiction/Tobacco addiction)

Registration Number: EUCTR2005-004626-10-DK

Lead Sponsor: Pulmonary Department, Gentofte Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

daily smokers>7 cigarettes per day
25-70 years old
Healty or
hypertension, increased cholestrol, type 2 diabetes,
mild asthma or COPD
motivated to quit smoking and to use test products
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

Severe disease
Psyciatric disorders
Use of antidepressant or antipsycotics drugs
>6 alcoholic drinks per day
Used NRT or bupropionSR during the last 2 weeks
Prenancy
lactating
Stoped smoking for more than 2 days the alst 3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if smokelees tobacco can be used fro smoking cessation compared with standard therapy i.e. buccal nicotine tablets 2 mg (Nicotinell) and with nicotine patch in low dose 7 mg/24 hours as control arm;Secondary Objective: To evalauate the safety of smokeless tobacco comapred with standard therapy<br>To evaluate the degree of nicotine substitution by these 3 products<br>To evaluate if focus on cholesterol, blood pressure, lung function can enhance adherence to a smoking cessation trial over 2 years<br>To look at the effect of repeated therapy ;Primary end point(s): Quit rate as point prevalence after 6 months and sustained quit rate i.e. no smoking from week 4 to 6 months plus Carbon monoxide < 8 pp at all visits

Secondary Outcome Measures