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Smoking Cessation in Groups and With Tobacco Pastils

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00265460
First received: December 13, 2005
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking
 Drug: Oliwer Twist smokeless tobacco (tobacco)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Continuous Smoking cessation quit rate after 6 and 12 months

Secondary Outcome Measures:
  • Side effects from tested tobacco product
  • Intake of nicotine and thiocyanate
Estimated Enrollment: 240
Study Start Date: March 2005
Study Completion Date: November 2006
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.

  Eligibility
Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265460

Locations
Denmark
Dept. pulmonary medicine Y, Gentofte University Hospital
Copenhagen, Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Study Chair: Philip Tønnesen, M.D., Ph.D. Chair dept. pulm. medicine, Gentofte Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00265460     History of Changes
Other Study ID Numbers: Tonga.2005.00.
Study First Received: December 13, 2005
Last Updated: September 14, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
smoking cessation,
nicotine,
smokeless tobacco,
cigarettes

ClinicalTrials.gov processed this record on March 03, 2015