Smoking
Conditions
Keywords
smoking cessation,, nicotine,, smokeless tobacco,, cigarettes
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.
Interventions
DRUGOliwer Twist smokeless tobacco (tobacco)
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous Smoking cessation quit rate after 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects from tested tobacco product | — |
| Intake of nicotine and thiocyanate | — |
Countries
Denmark
Outcome results
None listed