IRB Number:

09-002581

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Particpants in this research study currently chew tobacco and wish to stop.

Minimum Age:

18

Maximum Age:

100

What is Involved With this Study?

This study includes a screening period in which you will be informed of the study; if you decide to participate you will be asked to sign this study informed consent form.

Afterwards you will be asked to undergo a series of screening tests to see if you are eligible to participate in this study. The tests will include questions concerning your medical and tobacco use history, a brief physical exam, diagnostic tests to determine your nicotine dependence. If you are a woman, you will also have a pregnancy test using a urine sample.

After that you will be randomized (as in the flip of a coin) to one of two groups: 2 ? 21 mg of nicotine patches or matching placebo patches (inactive drug). You will stay on your assigned dose for 8 weeks with biweekly clinic visits (weeks 2, 4, 6,and 8).

When you complete your 8 weeks of study drug; you will return after four weeks (week 12) and then be asked to return for a final study visit (week 24).

Everyone in study will also receive nicotine dependence counseling.

How long will the Study run?

Six months

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
Nicotine Reseach Program at 800-848-7853 or 507-266-1944.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• LaCrosse,

Last updated: 08/20/2009