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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00313105 |
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Date of registration:
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10/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
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Scientific title:
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Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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600 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00313105 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Philip Tønnesen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chair dept. pulm. medicine, Gentofte Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
25 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco Dependence
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Intervention(s)
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Behavioral: smoking cessation counseling
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Drug: Smokeless tobacco (Oliver Twist pellets)
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Primary Outcome(s)
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Abstinence from smoking after ½ year (point and continuous abstinence)
[Time Frame: 6 months from entry]
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Secondary Outcome(s)
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Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
[Time Frame: 6,12,24 months from entry]
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Adverse events between 3 arms
[Time Frame: Up to 6 months from entry]
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Effect of retreatment (abstinence after 1, 1½ and 2 years)
[Time Frame: 12,18 and 24 months from entry]
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Adherence to study
[Time Frame: 6,12,24 months from entry]
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Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
[Time Frame: 3 and 6 months from entry]
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Secondary ID(s)
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2005-004626-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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