A Pilot Study Evaluating Nicotine Lozenges and Self Help
A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
Sponsor study identifier
Secondary identifiers
interventional
60
1 country
2
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
May 2009
Actual (reported)The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
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.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 2009
Actual (reported)April 24, 2009
Actual (reported)April 27, 2009
Actual (reported)May 2009
Actual (reported)November 4, 2010
Actual (reported)Number of Participants With Tobacco Abstinence
self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)
12 weeks
Self-help counseling material and 4 mg nicotine lozenges
self help counseling material and placebo nicotine lozenges
4 mg nicotine lozenges, ad lib, for 12 weeks.
Placebo nicotine lozenges
Mayo Clinic
Rochester, Minnesota, 55905, United States
Oregon Research Institute
Eugene, Oregon, 97403, United States
Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self-help for the treatment of smokeless tobacco users. Addict Behav. 2010 May;35(5):522-5. doi: 10.1016/j.addbeh.2009.12.020. Epub 2010 Jan 4.
Jon O Ebbert, MD
Mayo Clinic
60 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2009
First Posted
April 27, 2009
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
October 23, 2023
Results First Posted
November 4, 2010
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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