IRB Number:

09-003598

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This research study is for participants who currently smoke cigarettes and wish to stop smoking.

Who is Eligible to Participate in the Study?

Men and women 18 years of age and older who smoke and wish to quit

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 smoking history, a brief physical exam, diagnostic tests to determine your nicotine dependence, as well as 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: vareincline (1 mg by mouth twice a day) AND bupropion (150 mg by mouth twice a day) OR varenicline (1-mg by mouth twice a day) and bupropion placebo (inactive drug) twice a day. You will stay on your assigned dose for 12 weeks with biweekly clinic visits (phone call at week 1 and clinic visits at weeks 2, 4, 6, 8, 10 and 12).

When you complete your 12 weeks of study drug; you will be called at week 13, returnfor a clinic visit at week 14, be called for a visit at week 16 and return for visit at week 26 and then for a final study visit (week 52).

Everyone in study will also receive nicotine dependence counseling.

How long will the Study run?

One year

Who can I Contact for Additional Information on this Trial?

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

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Franciscan

Last updated: 08/20/2009