Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Smokeless tobacco (Oliver Twist pellets)
* Behavioral: smoking cessation counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smokeless Tobacco<br>Smokeless Tobacco and individual visits | Drug: Smokeless tobacco (Oliver Twist pellets)<br>* individual visits with counseling<br>Behavioral: smoking cessation counseling<br>* individual visits<br>|
| Active Comparator: Nicotine tablets<br>Nicotine tablets | Behavioral: smoking cessation counseling<br>* individual visits<br>|
| Placebo Comparator: 3<br>7-mg nicotine patch acts as placebo | Behavioral: smoking cessation counseling<br>* individual visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from smoking after ½ year (point and continuous abstinence) |  | 6 months from entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events between 3 arms |  | Up to 6 months from entry | 
| Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL) |  | 3 and 6 months from entry | 
| Adherence to study |  | 6,12,24 months from entry | 
| Effect of retreatment (abstinence after 1, 1½ and 2 years) |  | 12,18 and 24 months from entry | 
| Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status |  | 6,12,24 months from entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smokeless tobacco, nicotine patch, nicotine buccal tablets, smoking cessation, retreatment, adherence