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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

April 10, 2006
September 14, 2009
April 2006
April 2010   (final data collection date for primary outcome measure)
Abstinence from smoking after ½ year (point and continuous abstinence) [ Time Frame: 6 months from entry ] [ Designated as safety issue: No ]
Abstinence from smoking after ½ year (point and continuous abstinence)
Complete list of historical versions of study NCT00313105 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Adverse events between 3 arms
  • Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
  • Adherence to study
  • Effect of retreatment (abstinenc after 1, 1½ and 2 years)
  • Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Not Provided
Not Provided
 
Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Dependence
  • Drug: Smokeless tobacco (Oliver Twist pellets)
    individual visits with counseling
  • Behavioral: smoking cessation counseling
    individual visits
  • Experimental: Smokeless Tobacco
    Smokeless Tobacco and individual visits
    Interventions:
    • Drug: Smokeless tobacco (Oliver Twist pellets)
    • Behavioral: smoking cessation counseling
  • Active Comparator: Nicotine tablets
    Nicotine tablets
    Intervention: Behavioral: smoking cessation counseling
  • Placebo Comparator: 3
    7-mg nicotine patch acts as placebo
    Intervention: Behavioral: smoking cessation counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
August 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
25 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00313105
2005-004626-10
No
Philip Tønnesen, M.D., Gentofte Hospital
University Hospital, Gentofte, Copenhagen
Danish Research Foundation, FSS, Copenhagen, Denmark
Principal Investigator: Philip Tønnesen, M.D., Ph.D. Chair dept. pulm. medicine, Gentofte Hospital
University Hospital, Gentofte, Copenhagen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP