Status:

UNKNOWN

Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Lead Sponsor:

University Hospital, Gentofte, Copenhagen

Collaborating Sponsors:

Danish Research Foundation, FSS, Copenhagen, Denmark

Conditions:

Tobacco Dependence

Eligibility:

All Genders

25-70 years

Phase:

PHASE2

PHASE3

Brief Summary

To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches. Also retreatment will be tested with smo...

Detailed Description

This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for ...

Eligibility Criteria

Inclusion

  • smokers (\>7 cig/day)
  • Healthy
  • Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
  • mild asthma and COPD,
  • Motivated to quit smoking
  • Motivated to follow the protocol
  • Motivated to use medication in this trial

Exclusion

  • Severe diseases
  • Psychiatric diseases
  • Used NRT or Zyban the last 2 weeks
  • Stopped smoking \>2 days during last 3 months
  • More than 6 alcoholic drinks per day
  • Smokes other products than cigarettes
  • Pregnant of lactating

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2010

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT00313105

Start Date

April 1 2006

End Date

August 1 2010

Last Update

September 15 2009

Active Locations (1)

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Dept. pulmonary medicine Y, Gentofte University Hospital

Copenhagen, Hellerup, Denmark, 2900