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Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

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ClinicalTrials.gov Identifier: NCT00313105
Recruitment Status : Unknown
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2006
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Danish Research Foundation, FSS, Copenhagen, Denmark
Information provided by:
University Hospital, Gentofte, Copenhagen

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2006
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Abstinence from smoking after ½ year (point and continuous abstinence) [ Time Frame: 6 months from entry ]

Secondary Outcome Measures :
  1. Adverse events between 3 arms [ Time Frame: Up to 6 months from entry ]
  2. Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL) [ Time Frame: 3 and 6 months from entry ]
  3. Adherence to study [ Time Frame: 6,12,24 months from entry ]
  4. Effect of retreatment (abstinence after 1, 1½ and 2 years) [ Time Frame: 12,18 and 24 months from entry ]
  5. Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status [ Time Frame: 6,12,24 months from entry ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313105


Locations
Denmark
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Danish Research Foundation, FSS, Copenhagen, Denmark
Investigators
Principal Investigator: Philip Tønnesen, M.D., Ph.D. Chair dept. pulm. medicine, Gentofte Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Philip Tønnesen, M.D., Gentofte Hospital
ClinicalTrials.gov Identifier: NCT00313105     History of Changes
Other Study ID Numbers: 2005-004626-10
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by University Hospital, Gentofte, Copenhagen:
smoking cessation
smokeless tobacco
nicotine patch
 nicotine buccal tablets
retreatment
adherence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Lobeline
Ganglionic Stimulants
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents