Smoking Cessation in Groups and With Tobacco Pastils
- Conditions
- Smoking
- Registration Number
- NCT00265460
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Continuous Smoking cessation quit rate after 6 and 12 months
- Secondary Outcome Measures
Name Time Method Side effects from tested tobacco product Intake of nicotine and thiocyanate
Trial Locations
- Locations (1)
Dept. pulmonary medicine Y, Gentofte University Hospital
🇩🇰Copenhagen, Hellerup, Denmark