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
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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 |
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 |
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
|
- Abstinence from smoking after ½ year (point and continuous abstinence) [ Time Frame: 6 months from entry ]
- Adverse events between 3 arms [ Time Frame: Up to 6 months from entry ]
- Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL) [ Time Frame: 3 and 6 months from entry ]
- Adherence to study [ Time Frame: 6,12,24 months from entry ]
- Effect of retreatment (abstinence after 1, 1½ and 2 years) [ Time Frame: 12,18 and 24 months from entry ]
- Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status [ Time Frame: 6,12,24 months from entry ]

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

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
Denmark | |
Dept. pulmonary medicine Y, Gentofte University Hospital | |
Copenhagen, Hellerup, Denmark, 2900 |
Principal Investigator: | Philip Tønnesen, M.D., Ph.D. | Chair dept. pulm. medicine, Gentofte Hospital |
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 |