Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Smokeless tobacco (Oliver Twist pellets)
  • individual visits with counseling
• Behavioral: smoking cessation counseling
  • individual visits

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Smokeless Tobacco
  • Smokeless Tobacco and individual visits
• Active Comparator: Nicotine tablets
  • Nicotine tablets
• Placebo Comparator: 3
  • 7-mg nicotine patch acts as placebo

Primary Measures

• Abstinence from smoking after ½ year (point and continuous abstinence)
  • Time Frame: 6 months from entry
    Safety Issue?: No

Secondary Measures

• Adverse events between 3 arms
  • Time Frame: Up to 6 months from entry
    Safety Issue?: Yes
• Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
  • Time Frame: 3 and 6 months from entry
    Safety Issue?: Yes
• Adherence to study
  • Time Frame: 6,12,24 months from entry
    Safety Issue?: No
• Effect of retreatment (abstinence after 1, 1½ and 2 years)
  • Time Frame: 12,18 and 24 months from entry
    Safety Issue?: No
• Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
  • Time Frame: 6,12,24 months from entry
    Safety Issue?: 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University Hospital, Gentofte, Copenhagen Other

Overall Clinical Trial Officials and Contacts

Philip Tønnesen, M.D., Ph.D. Principal Investigator Chair dept. pulm. medicine, Gentofte Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00313105

Study ID Number: 2005-004626-10

ClinicalTrials.gov Identifier: NCT00313105

Health Authority: Denmark: National Board of Health