Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.
Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.
This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Smokeless tobacco (Oliver Twist pellets), smoking cessation counseling
Dept. pulmonary medicine Y, Gentofte University Hospital
Active, not recruiting
University Hospital, Gentofte, Copenhagen
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00313105
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tobacco Use Cessation
Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.
Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.
The powdered leaves of Nicotiana tabacum which are either inhaled through the nose, chewed, or stored in cheek pouches. It includes any product of tobacco that is not smoked.
Inhaling and exhaling the smoke of tobacco or something similar to tobacco.
A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.
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