Smopking (nicotine addiction/Tobacco addiction)
Conditions
Interventions
Trade Name: Nicotinell Mintsugetabletter 2 mg
Product Name: Nicotinell Mint Sugetabletter 2 mg
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: nicotine
Trade Name: Nicotinell Depotplaster 7mg
Sponsors
Pulmonary Department, Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To evaluate the degree of nicotine substitution by these 3 products To evaluate if focus on cholesterol, blood pressure, lung function can enhance adherence to a smoking cessation trial over 2 years 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 | — |
Countries
Denmark
Outcome results
None listed