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Smoking Cessation in Groups and With Tobacco Pastils

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ClinicalTrials.gov Identifier: NCT00265460
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen

Study Description
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Brief Summary:
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

Condition or disease Intervention/treatment Phase
Smoking Drug: Oliwer Twist smokeless tobacco (tobacco) Phase 2

Detailed Description:
The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
Study Start Date : March 2005
Actual Study Completion Date : November 2006

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Continuous Smoking cessation quit rate after 6 and 12 months

Secondary Outcome Measures :
  1. Side effects from tested tobacco product
  2. Intake of nicotine and thiocyanate

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:

  • smoking > 13 cigarettes/day
  • healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
  • motivated for cessation
  • motivated to use tobacco pastils
  • motivated for group support

Exclusion Criteria:

  • severe diseases
  • psychiatric diseases
  • using antipsychotic drugs
  • used NRT/bupropion in the last 3 months
  • consuming > 6 drinks/day
  • pregnant/lactating
  • stopped smoking more than 2 days during last 3 months
Contacts and Locations
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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): NCT00265460


Locations
Denmark
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Study Chair: 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

Publications of Results:

ClinicalTrials.gov Identifier: NCT00265460     History of Changes
Other Study ID Numbers: Tonga.2005.00.
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by University Hospital, Gentofte, Copenhagen:
smoking cessation,
nicotine,
smokeless tobacco,
cigarettes

Additional relevant MeSH terms:
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