Trial | NCT00313105  Report issue

Title

Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    tobacco ...

  • Study Participants

    600
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 Started
Apr 30
2006
Primary Completion
Apr 30
2010
Anticipated
Study Completion
Aug 31
2010
Anticipated
Last Update
Sep 15
2009
Estimate

Drug Smokeless tobacco (Oliver Twist pellets)

individual visits with counseling

Behavioral smoking cessation counseling

individual visits

Smokeless Tobacco Experimental

Smokeless Tobacco and individual visits

Nicotine tablets Active Comparator

Nicotine tablets

3 Placebo Comparator

7-mg nicotine patch acts as placebo

Criteria 

Inclusion Criteria:

smokers (>7 cig/day)
Healthy
Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
mild asthma and COPD,
Motivated to quit smoking
Motivated to follow the protocol
Motivated to use medication in this trial

Exclusion Criteria:

Severe diseases
Psychiatric diseases
Used NRT or Zyban the last 2 weeks
Stopped smoking >2 days during last 3 months
More than 6 alcoholic drinks per day
Smokes other products than cigarettes
Pregnant of lactating
No Results Posted