Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Unknown status

CT.gov ID

NCT00313105

Collaborator

Danish Research Foundation, FSS, Copenhagen, Denmark (Other)

600

Enrollment

Location

Arms

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Dependence	Drug: Smokeless tobacco (Oliver Twist pellets) Behavioral: smoking cessation counseling	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Smokeless Tobacco

Smokeless Tobacco and individual visits

Drug: Smokeless tobacco (Oliver Twist pellets)

individual visits with counseling

Behavioral: smoking cessation counseling

individual visits

Active Comparator: Nicotine tablets

Nicotine tablets

Behavioral: smoking cessation counseling

individual visits

Placebo Comparator: 3

7-mg nicotine patch acts as placebo

Behavioral: smoking cessation counseling

individual visits

Outcome Measures

Primary Outcome Measures

Abstinence from smoking after ½ year (point and continuous abstinence) [6 months from entry]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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