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

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Quitting Smoking Smokeless Tobacco Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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


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:


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

ClinicalTrials.gov processed this record on September 29, 2016

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