McLean Hospital to Look at New Treatments for Alcoholism

Named as national site for NIH clinical trial

March 8, 2001 -- Belmont, MA --  The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health has named McLean Hospital as a clinical trial site for a nationwide study testing new treatments for alcoholism.

The Combining Medications and Behavioral Interventions (COMBINE) study is the first national study to evaluate the effectiveness of behavioral treatments alone and in combination with medications. Over the next 24 months, the COMBINE study will recruit 1,375 people nationwide.

McLean researchers, working with investigators from Massachusetts General Hospital, are looking to enroll 125 people in total for the study. McLean is the founding institution of National Alcohol Screening Day, which takes place this year on Thursday, April 5, and helped some 30,000 Americans in 2000.

Participants of the COMBINE study will receive one or both of two behavioral therapies (moderate-intensity and lower-intensity), and one or both of two medications (naltrexone and acamprosate) or a placebo. They will attend outpatient therapy sessions for four months, then return for three follow-up visits over the subsequent 12 months.

"Statistics have shown us that as many as 50 percent of those who receive treatment for alcoholism relapse at least once. The clinical trials we will be performing over the next two years may lead to better treatment for those afflicted with this often debilitating disease," said Roger Weiss, MD, clinical director of McLean’s Alcohol and Drug Abuse Treatment Center and the principal investigator for the McLean study site.

To date, two of the most promising pharmacologic treatments for alcoholism are naltrexone, approved by the U.S. Food and Drug Administration (FDA) in 1994, and acamprosate, in use in Europe for about 14 years and currently under FDA review. Naltrexone, an opioid blocker, interferes with brain neurotransmitter systems that produce the rewarding effects of alcohol. Researchers have shown that naltrexone-treated patients are less likely to relapse to heavy drinking. Acamprosate is believed to normalize the brain’s systems involved in alcohol withdrawal and may ease the discomfort of abstinence, thereby helping to prevent drinking. Among other questions, COMBINE will explore whether treatment effectiveness is improved by pairing the two medications together.

The moderate-intensity behavioral treatment developed for COMBINE integrates motivational enhancement therapy, cognitive-behavioral skills training and facilitated patient involvement in mutual-help groups, such as Alcoholics Anonymous. The lower-intensity behavioral treatment is designed to support sobriety, enhance medication compliance and be incorporated into the daily routine of health-care practitioners in primary and managed-care settings.

In addition to 8 million Americans with alcohol dependence, about 6 million meet diagnostic criteria for alcohol abuse disorder. More than one-half of adult Americans have direct family experience of alcohol problems, which cost American society more than 100,000 lives and approximately $185 billion each year.

The COMBINE study, at no cost to participants, is recruiting people aged 18 years and older. Anyone interested in finding a clinical trial site in his/her area should call 1-866-80-STUDY. Participants must be willing to be screened for alcoholism and be abstinent for a minimum of four days and a maximum of 21 days prior to the study.

NIAAA is the lead federal entity for research on the causes, consequences, prevention, and treatment of alcoholism, alcohol abuse, and alcohol-related problems.