Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborator:
Danish Research Foundation, FSS, Copenhagen, Denmark
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00313105
First received: April 10, 2006
Last updated: September 14, 2009
Last verified: September 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tobacco Dependence |
Drug: Smokeless tobacco (Oliver Twist pellets) Behavioral: smoking cessation counseling |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Gentofte, Copenhagen:
Primary Outcome Measures:
- Abstinence from smoking after ½ year (point and continuous abstinence) [ Time Frame: 6 months from entry ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events between 3 arms [ Time Frame: Up to 6 months from entry ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
- Adherence to study [ Time Frame: 6,12,24 months from entry ] [ Designated as safety issue: No ]
- Effect of retreatment (abstinence after 1, 1½ and 2 years) [ Time Frame: 12,18 and 24 months from entry ] [ Designated as safety issue: No ]
- Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status [ Time Frame: 6,12,24 months from entry ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313105
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Philip Tønnesen, M.D., Gentofte Hospital |
| ClinicalTrials.gov Identifier: | NCT00313105 History of Changes |
| Other Study ID Numbers: | 2005-004626-10 |
| Study First Received: | April 10, 2006 |
| Last Updated: | September 14, 2009 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by University Hospital, Gentofte, Copenhagen:
|
smoking cessation smokeless tobacco nicotine patch |
nicotine buccal tablets retreatment adherence |
Additional relevant MeSH terms:
|
Lobeline Nicotine Autonomic Agents Cholinergic Agents Cholinergic Agonists Ganglionic Stimulants Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Nicotinic Agonists Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015