Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Phase 2

• Conditions: Tobacco Dependence
• Interventions: Behavioral: smoking cessation counseling; Drug: Smokeless tobacco (Oliver Twist pellets)

• Registration Number: NCT00313105
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief 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.

Detailed 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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15
• Primary Completion: 2010-04
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine tablets	smoking cessation counseling	Nicotine tablets
Smokeless Tobacco	Smokeless tobacco (Oliver Twist pellets)	Smokeless Tobacco and individual visits
Smokeless Tobacco	smoking cessation counseling	Smokeless Tobacco and individual visits
3	smoking cessation counseling	7-mg nicotine patch acts as placebo

Primary Outcome Measures

Name	Time	Method
Abstinence from smoking after ½ year (point and continuous abstinence)	6 months from entry

Secondary Outcome Measures

Name	Time	Method
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
Adverse events between 3 arms	Up to 6 months from entry

Trial Locations

Locations (1)

Dept. pulmonary medicine Y, Gentofte University Hospital; 🇩🇰 Copenhagen, Hellerup, Denmark