Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Lobeline; Nicotine

Criteria

Inclusion Criteria:

1. are at least 18 years of age and at most 55 years of age;

2. report daily ST use for the past 12 months;

3. identify ST as their primary tobacco product;

4. use an average of ≥ 3 cans/pouches per week;

5. are in general good health (determined by medical history and screening physical examination);

6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

1. are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;

2. are currently pregnant or lactating;

3. have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;

4. have a history of arrhythmia or an abnormal tracing on the baseline EKG;

5. have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;

6. have a history of severe skin allergies or dermatoses;

7. have a history of intolerance to nicotine patches;

8. have another member of their household already participating in this study;

9. are taking a medication known to interact with nicotine (i.e., clozapine);

10. are taking any prescription medication for depression or asthma