Smoking Cessation in Groups and With Tobacco Pastils - Full Text View

Purpose

The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

Condition	Intervention	Phase
Smoking	Drug: Oliwer Twist smokeless tobacco (tobacco)	Phase II

MedlinePlus related topics:

Smokeless Tobacco Smoking Smoking Cessation

ChemIDplus related topics:

Nicotine polacrilex Nicotine tartrate Lobeline Lobeline hydrochloride Lobeline sulfate

U.S. FDA Resources

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

Official Title:	Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

Continous Smoking cessation quit rate after 6 and 12 months

Secondary Outcome Measures:

Side effects from tested tobacco product
Intake of nicotine and thiocyanate

Estimated Enrollment:	240
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2006

Detailed Description:

The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product skould be used for 7 weeks. Seven group meetings are planend during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Smokers >13 cig/day healty (allowed: hypertension, diabets type 2, mild asthma/COPD, hypercholestolemia) motivated for cessation motivated to use tobacco pastils motivated fro group support

Exclusion Criteria:

Severe diseases, psyciatric diseases, using antipsycotic drugs, used NRT/bupropion the last 3 months,> 6 drinks/day, pregnant/lactating, stopped smoking more than 2 days during last 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265460

Locations


Denmark, Hellerup
	Dept. pulmonary medicine Y, Gentofte University Hospital
	Copenhagen, Hellerup, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators


Study Chair:	Philip Tønnesen, M.D., Ph.D.	Chair dept. pulm. medicine, Gentofte Hospital

More Information

Study ID Numbers:	Tonga.2005.00.
First Received:	December 13, 2005
Last Updated:	December 13, 2005
ClinicalTrials.gov Identifier:	NCT00265460
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:

smoking cessation,

nicotine,

smokeless tobacco,

cigarettes

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Lobeline

Nicotine

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Cholinergic Agonists

Molecular Mechanisms of Pharmacological Action

Nicotinic Agonists

Physiological Effects of Drugs

Cholinergic Agents

Pharmacologic Actions

Habits

Autonomic Agents

Therapeutic Uses

Ganglionic Stimulants

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00265460