IRB Number:

07-006604

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to compare two doses of S-Adenosyl-L-Methionine (SAMe) or placebo (an inactive substance) to see if they can help smokers stop smoking.

Minimum Age:

18

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. You will be put in one of 3 groups by chance (as in the flip of a coin): 800 mg/day of SAMe, 1600 mg /day of SAMe or a matching placebo (inactive substance). You will stay on your assigned dose for 8 weeks with weekly (visits 3-6) or biweekly (visits 7-8) clinic visits. You will take up to 2 pills twice a day, for a total of 4 pills per day. A schedule of how you will build up to that amount will be given to you, along with appropriate instructions by the study nurse, when you are given the study medication. Everyone in the study will also receive nicotine dependence counseling.

You will be asked to participate in a phone visit, 8 weeks after your study medication is finished (visit 9), and a final study visit in the clinic at week 24 (visit 10).

How long will the Study run?

You will be in the study for 6 months.

For more information or to participate in this research study please contact the 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: 04/03/2009