NIAAA Launches Study Of Alcoholism Treatments

What appears to be the first national study to evaluate the effectiveness of behavioral treatments alone for alcoholism or in combination with medications is being launched by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in Bethesda, Md.

The study is called “COMBINE,” for “Combining Medications and Behavioral Interventions.” It will take place at 11 university research centers across the United States. Some 1,400 persons who meet diagnostic criteria for alcoholism will be recruited for it. Richard Fuller, M.D., director of NIAAA’s division of clinical and prevention research, explained to Psychiatric News how it is being set up.

First, subjects will be allocated to one of two different behavioral therapy arms. Those in one arm will receive the kind of counseling that a patient would get in medical practice to support sobriety. Those in the other arm will get more intense therapy that is designed for alcohol treatment programs, such as cognitive behavioral therapy and Alcoholics Anonymous mutual self-help.

Then each of the behavioral therapy arms will be divided into four different groups. One group will get a placebo, one group will get the drug naltrexone alone, the third group will get acamprosate alone, and the fourth group will get both naltrexone and acamprosate.

“So in a sense,” Fuller said, “there are eight [components], because there are two behavioral therapies and four medication therapies in each arm.”

Naltrexone is an opioid blocker that interferes with brain neurotransmitter systems that produce the rewarding effects of alcohol. Naltrexone-treated patients are less likely to relapse to heavy drinking, past studies have shown. Naltrexone was approved as an alcoholism treatment by the U.S. Food and Drug Administration in 1994. Acamprosate is believed to normalize abnormalities in the glutamate and GABA neurotransmitters involved in alcohol withdrawal and may ease the discomfort of abstinence, thereby helping to prevent drinking. Acamprosate has been used against alcoholism in Europe for some 14 years and is currently under review by the FDA for possible approval in the United States.

The COMBINE study is recruiting people aged 18 years and older. Persons interested in participating may determine their geographic eligibility by calling (886) 80-STUDY. ▪