NCT00265460

Smoking Cessation in Groups and With Tobacco Pastils

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Smoking

Interventions

Type	Name	Description
DRUG	Oliwer Twist smokeless tobacco (tobacco)

Timeline

• Start date: 2005-03-01
• Completion: 2006-11-01
• First posted: 2005-12-14
• Last updated: 2009-09-15

Locations

1 site across 1 country: Denmark