Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
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|ClinicalTrials.gov Identifier: NCT01018394|
Recruitment Status : Completed
First Posted : November 23, 2009
Results First Posted : September 13, 2013
Last Update Posted : September 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Drug: nicotine lozenges Drug: tobacco-free snuff||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: nicotine lozenges
40 subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.
Drug: nicotine lozenges
4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
Active Comparator: tobacco free snuff
41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
Drug: tobacco-free snuff
Tobacco-free snuff used ad lib for a maximum of 12 weeks
- Tobacco Abstinence at 12 Weeks [ Time Frame: week 12 ]Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.
- Smokeless Tobacco Reduction Greater or Equal to 50% [ Time Frame: baseline, week 4 ]Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018394
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Oregon|
|Oregon Research Institute|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Jon O Ebbert, MD||Mayo Clinic|