Smoking Cessation in Groups and With Tobacco Pastils

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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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

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oliwer Twist smokeless tobacco (tobacco)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes