Smoking Cessation in Groups and With Tobacco Pastils

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 2

Conditions: Smoking

Treatments: Drug: Oliwer Twist smokeless tobacco (tobacco)

Study type: Interventional

Funder types: Other

Identifiers

NCT00265460

Tonga.2005.00.

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)