IRB Number:

08-005359

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

You are being asked to take part in this research study because you currently chew tobacco and wish to stop.

Who is Eligible to Participate in the Study?

A total of 60 ST users will be recruited into this clinical trial. Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have used ST daily for the past 12 months (regular user); 3) identify ST as their primary tobacco product; 4) are in general good health (determined by medical history and screening physical examination); 5) has provided written informed consent to participate; and 6) are able to participate in all aspects of the study.

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: varenicline 1-mg by mouth twice per day or a matching placebo (inactive drug). You will stay on your assigned dose for 12 weeks with weekly or biweekly clinic visits (weeks 1-4,6,8,10 and 12). While on the study medication, you will be called for a brief phone visit on the weeks that you do not come in for a clinic visit (weeks 5,7,9,and 11). When you complete your 12 weeks of study drug; you will return after two weeks (week 14) 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?

You will be in the study for 6 months.

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 Dependence Center Research Program
200 First Street, SW
Rochester, MN 55905
USA

Tel: 507-266-1944
Toll Free: 1-800-848-7853
Fax: 507-266-7900
E-mail: nicotineresearch@mayo.edu

Outreach Site

Franciscan Skemp Healthcare
Behavioral Health/Nicotine Research
212 South 11th Street
LaCrosse, WI 54601
USA

Tel: 608-791-4197
Fax: 608-791-9733

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Franciscan

Last updated: 04/16/2009