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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

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 Sponsor: University Hospital, Gentofte, Copenhagen

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Philip Tønnesen, M.D., Ph.D. (+45) 39 77 35 08 philipt@dadlnet.dk

Information obtained from ClinicalTrials.gov on July 02, 2009

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