IRB Number:

06-003091

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to see if 4-mg nicotine lozenges will be help smokeless tobacco users stop tobacco.

Who is Eligible to Participate in the Study?

Men or women may be eligible if they:

• are at least 18 years of age;


• report ST as their primary tobacco of use;


• have used ST daily for the past 6 months;


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


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

What is Involved With this Study?

During the clinic screen visit (visit 1) you will be informed about details of the study, after reading this document which informs you of your rights concerning study participation, you will be given the opportunity to sign it and thereby indicating your willingness to participate in this study. After you sign this consent form, a series of screening tests will be conducted to see if you are eligible to participate in the study. If you are found to be eligible for study participation you will return for a baseline visit (visit 2), whereby a physical exam and medical history will be done by a study physician. After that you will be randomized (as in the flip of a coin) to one of two groups: 4 mg Nicotine Lozenges ad lib per day or a matching placebo. You will stay on your assigned dose for 12 weeks with weekly or biweekly clinic visits (visit 3-6). When they complete you 12 weeks of study drug, you will be asked to return for a final study visit (visit 7).

During each study visit, vital signs will be measured and you will be asked questions about nicotine withdrawal and the drug side effects and concomitant medications taken. At each visit tobacco use status will be documented and tobacco abstinence confirmed by expired air Carbon Monoxide and urine cotinine measures. Please remember that your target quit day will be the day after your randomization day, the day you actually begin taking the study medication.

How long will the Study run?

Participants will be in this study for a total of six months and will take nicotine lozenges for 12 weeks.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information or to participate in this research study please contact the Nicotine Research Program at 800-848-7853 or (507) 266-1944 for our Rochester office and (608) 791-4197 for our LaCrosse Office.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• LaCrosse,

Last updated: 01/31/2008