Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Danish Research Foundation, FSS, Copenhagen, Denmark
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00313105
First received: April 10, 2006
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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 smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.


Condition Intervention Phase
Tobacco Dependence
Drug: Smokeless tobacco (Oliver Twist pellets)
Behavioral: smoking cessation counseling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Abstinence from smoking after ½ year (point and continuous abstinence) [ Time Frame: 6 months from entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events between 3 arms [ Time Frame: Up to 6 months from entry ] [ Designated as safety issue: Yes ]
  • Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL) [ Time Frame: 3 and 6 months from entry ] [ Designated as safety issue: Yes ]
  • Adherence to study [ Time Frame: 6,12,24 months from entry ] [ Designated as safety issue: No ]
  • Effect of retreatment (abstinence after 1, 1½ and 2 years) [ Time Frame: 12,18 and 24 months from entry ] [ Designated as safety issue: No ]
  • Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status [ Time Frame: 6,12,24 months from entry ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: April 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokeless Tobacco
Smokeless Tobacco and individual visits
Drug: Smokeless tobacco (Oliver Twist pellets)
individual visits with counseling
Behavioral: smoking cessation counseling
individual visits
Active Comparator: Nicotine tablets
Nicotine tablets
Behavioral: smoking cessation counseling
individual visits
Placebo Comparator: 3
7-mg nicotine patch acts as placebo
Behavioral: smoking cessation counseling
individual visits

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 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.

  Eligibility

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

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT00313105

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

No publications provided

Responsible Party: Philip Tønnesen, M.D., Gentofte Hospital
ClinicalTrials.gov Identifier: NCT00313105     History of Changes
Other Study ID Numbers: 2005-004626-10
Study First Received: April 10, 2006
Last Updated: September 14, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
smoking cessation
smokeless tobacco
nicotine patch
nicotine buccal tablets
retreatment
adherence

Additional relevant MeSH terms:
Lobeline
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014