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Smoking Cessation in Groups and With Tobacco Pastils

Smoking Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00265460
Study type Interventional
Source University Hospital, Gentofte, Copenhagen
Contact
Status Completed
Phase Phase 2
Start date March 2005
Completion date November 2006
View Details
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