Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches - Full Text View

Sponsors and Collaborators:	University Hospital, Gentofte, Copenhagen Danish Research Foundation, FSS, Copenhagen, Denmark
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00313105

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 II Phase III

MedlinePlus related topics: Cholesterol Quitting Smoking Smokeless Tobacco Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate Lobeline Lobeline sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Smokeless Tobacco: Experimental Smokeless Tobacco and individual visits	Drug: Smokeless tobacco (Oliver Twist pellets) individual visits with counseling Behavioral: smoking cessation counseling individual visits
Nicotine tablets: Active Comparator Nicotine tablets	Behavioral: smoking cessation counseling individual visits
3: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313105

Contacts

Contact: Philip Tønnesen, M.D., Ph.D.	(+45) 39 77 35 08	philipt@dadlnet.dk
Contact: Philip Tønnesen, R.N.	(+45) 39 77 35 14	libre@gentoftehosp.kbhamt.dk

Locations

Denmark, Hellerup
Dept. pulmonary medicine Y, Gentofte University Hospital	Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Linda Bremann, R.N. +45 39 77 35 12 libre@gentoftehosp.kbhamt.dk
Principal Investigator: Philip Tønnesen, M.D., Ph.D.

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

Responsible Party:	Gentofte Hospital ( Philip Tønnesen, M.D. )
Study ID Numbers:	2005-004626-10
Study First Received:	April 10, 2006
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00313105
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

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Lobeline
Nicotine

Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants

Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009