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Completed

NCT Number: NCT00265460

Smoking Cessation in Groups and With Tobacco Pastils

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.

Completed

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation Tobacco Use

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept. pulmonary medicine Y, Gentofte University Hospital

Copenhagen, Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oliwer Twist smokeless tobacco (tobacco)

Drug

Primary outcomes

  1. Continuous Smoking cessation quit rate after 6 and 12 months

Secondary outcomes

  1. Side effects from tested tobacco product

  2. Intake of nicotine and thiocyanate

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Dec 14, 2005
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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