NCT00939029|CompletedPhase 2/3ResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
52
1 country
1
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2009
Actual (reported)July 14, 2009
Actual (reported)July 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)June 2013
Actual (reported)April 25, 2014
Actual (reported)End of Treatment (Week 8) Point Prevalence Abstinence
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine \< 2 ng per ml
weeks 8
Point-prevalence Abstinence at 3 Months
week 12
Point-prevalence Abstinence at 6 Months
week 24
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
2 patches (containing non active ingredients) per day for 8 weeks
2- 21 mg patches per day for 8 weeks
2 placebo patches (containing no active ingredient)per day for 8 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ebbert JO, Croghan IT, Schroeder DR, Hurt RD. A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users. Nicotine Tob Res. 2013 Dec;15(12):2037-44. doi: 10.1093/ntr/ntt097. Epub 2013 Jul 19.
Jon O Ebbert, MD
Mayo Clinic
52 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2009
First Posted
July 14, 2009
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects
Contact the study team to confirm eligibility.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
May 19, 2014
Results First Posted
April 25, 2014
Record last verified: 2014-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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