What is this study evaluating?

Researchers are evaluating the effectiveness of a natural substance and dietary supplement called S-adenosylmethionine, or SAMe, as a treatment for alcoholic liver disease by reducing inflammation.

Researchers are also recruiting two additional subject populations, healthy volunteers and active drinkers without alcoholic liver disease. These populations are needed as comparison groups for alcoholic liver disease patients enrolled in the study.

What is alcoholic liver disease?

Alcoholic liver disease involves an acute or chronic inflammation of the liver induced by alcohol abuse. It is also sometimes called cirrhosis.

Who can join this trial?

For participants with alcoholic liver disease:

• Men and women between 21 and 65 years with alcoholic liver disease who have a history of alcohol use, who are willing to stop drinking during the study, and who have negative tests for both hepatitis B and C.

For participants who are healthy volunteers:

• Men and women between 21 and 65 years who have a maximum of one alcoholic drink per day, who are absence of any chronic disease and who have negative tests for both hepatitis B and C.
• Selection criteria will be based on gender and age variables to match with liver disease patient.

For participants who are active drinkers without alcoholic liver disease:

• Men and women between 21 and 65 years who have at least 5 alcoholic drinks (men) or 3 drinks (women) daily, who are absence of any chronic disease and who have negative tests for both hepatitis B and C.
• Selection criteria will be based on gender and age variables to match with liver disease patient.

What is required?

For participants with alcoholic liver disease:

• Taking oral SAMe or a placebo three times a day for six months
• 10 visits to the UC Davis Clinical Research Center, located at Sacramento VA Medical Center at Mather
• Willingness to consent to two bedside needle liver biopsies, one at the beginning and one at the end of the study

For participants who are healthy volunteers or active drinkers without alcoholic liver disease:

• One visit to the UC Davis Clinical Research Center, located at the Sacramento VA Medical Center at Mather
• Willingness to consent to one-time blood draw

Principal Investigator

Charles Halsted, M.D., Department of Internal Medicine, Division of Endocrinology, Clinical Nutrition and Vascular Medicine

Co-Investigator

Valentina Medici, M.D., Department of Internal Medicine, Division of Gastroenterology and Hepatology

For more information please contact study coordinator Maria Catrina Virata, Clinical Research Associate at (916) 734-2670

Return to Clinical Trials home page.