Smoking Cessation in Groups and With Tobacco Pastils

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT00265460

First received: December 13, 2005

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smokeless Tobacco Smoking

U.S. FDA Resources

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

Primary Outcome Measures:

Continuous 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
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 should be used for 7 weeks. Seven group meetings are planned 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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

smoking > 13 cigarettes/day
healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
motivated for cessation
motivated to use tobacco pastils
motivated for group support

Exclusion Criteria:

severe diseases
psychiatric diseases
using antipsychotic drugs
used NRT/bupropion in the last 3 months
consuming > 6 drinks/day
pregnant/lactating
stopped smoking more than 2 days during last 3 months

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: NCT00265460

Locations


Denmark
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

Publications:

Tønnesen P, Mikkelsen K, Bremann L. Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial. Nicotine Tob Res. 2008 Aug;10(8):1365-72. doi: 10.1080/14622200802238969.


ClinicalTrials.gov Identifier:	NCT00265460 History of Changes
Other Study ID Numbers:	Tonga.2005.00.
Study First Received:	December 13, 2005
Last Updated:	September 14, 2009

Keywords provided by University Hospital, Gentofte, Copenhagen:


smoking cessation, nicotine, smokeless tobacco, cigarettes

Additional relevant MeSH terms:


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 August 18, 2017

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