Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

University Hospital, Gentofte, Copenhagen

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Tobacco Dependence

Treatments: Behavioral: smoking cessation counseling; Drug: Smokeless tobacco (Oliver Twist pellets)

Study type: Interventional

Funder types: Other

Identifiers

NCT00313105

2005-004626-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups, including a placebo group

Smokeless Tobacco

Experimental group

Description:

Smokeless Tobacco and individual visits

Treatment:

Behavioral: smoking cessation counseling

Drug: Smokeless tobacco (Oliver Twist pellets)

Nicotine tablets

Active Comparator group

Description:

Nicotine tablets

Treatment:

Behavioral: smoking cessation counseling

3

Placebo Comparator group

Description:

7-mg nicotine patch acts as placebo

Treatment:

Behavioral: smoking cessation counseling