Highdose Nicotine Patch Therapy for Smokeless Tobacco Use (NCT00939029) | Clinical Trial Compass
CompletedPhase 2/3
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
United States52 participantsStarted 2010-07
Plain-language 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 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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;
✕
What they're measuring
1
End of Treatment (Week 8) Point Prevalence Abstinence