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Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

13:19 EDT 25th May 2013 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tobacco Dependence

Intervention

Smokeless tobacco (Oliver Twist pellets), smoking cessation counseling

Location

Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen
Hellerup
Denmark
2900

Status

Active, not recruiting

Source

University Hospital, Gentofte, Copenhagen

Results (where available)

View Results

Links

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.

Smoking Cessation

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

Tobacco, Smokeless

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.

Smoking

Inhaling and exhaling the smoke of tobacco or something similar to tobacco.

Tobacco

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

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