Status:
COMPLETED
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Smokeless Tobacco Use
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and...
Detailed Description
Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinic...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- are at least 18 years of age;
- report smokeless tobacco (ST) as their primary tobacco of use;
- have used ST daily for the past 6 months;
- are in general good health (determined by medical history and screening physical examination);
- have been provided with, understand, and have signed the informed consent.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00392379
Start Date
January 1 2007
End Date
March 1 2009
Last Update
April 24 2013
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Oregon Research Institute
Eugene, Oregon, United States, 97403