Status:
COMPLETED
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Lead Sponsor:
Mayo Clinic
Conditions:
Smokeless Tobacco Use
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
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 c...
Detailed Description
Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being...
Eligibility Criteria
Inclusion
- are at least 18 years of age and at most 55 years of age;
- report daily ST use for the past 12 months;
- identify ST as their primary tobacco product;
- use an average of ≥ 3 cans/pouches per week;
- 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
- are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- are currently pregnant or lactating;
- have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
- have a history of arrhythmia or an abnormal tracing on the baseline EKG;
- have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
- have a history of severe skin allergies or dermatoses;
- have a history of intolerance to nicotine patches;
- have another member of their household already participating in this study;
- are taking a medication known to interact with nicotine (i.e., clozapine);
- are taking any prescription medication for depression or asthma
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00939029
Start Date
July 1 2010
End Date
June 1 2013
Last Update
May 19 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905