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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
individual visits with counseling
individual visits
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, Denmark
Abstinence from smoking after ½ year (point and continuous abstinence)
Time frame: 6 months from entry
Adverse events between 3 arms
Time frame: Up to 6 months from entry
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Time frame: 3 and 6 months from entry
Adherence to study
Time frame: 6,12,24 months from entry
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Time frame: 12,18 and 24 months from entry
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Time frame: 6,12,24 months from entry
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