Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
|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
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|