The Food and Drug Administration (FDA) has approved acamprosate (Campral), for treating alcohol-dependent individuals seeking to continue to remain alcohol free after they have stopped drinking.
It is the first new drug approved for alcohol abuse since naltrexone was approved in January 1995.
Marc Galanter, M.D., told Psychiatric News that acamprosate is one of several drugs that, when used alone or in combination, offer new promise to alcoholics.
But he said that successful use of acamprosate, as with naltrexone and the other drugs, depends entirely on compliance by the patient. “For that reason, the psychosocial treatment context in which the drugs are given determines their effectiveness,” Galanter said.
He is professor of psychiatry and director of the Division of Alcoholism and Drug Abuse at New York University School of Medicine.
Galanter said that he and colleagues have developed a course and manual on“ psychosocial network therapy.”
Galanter noted that a number of studies in Europe have shown acamprosate to be effective for reducing craving and the amount that alcoholics may drink when they do drink.
The drug was submitted for FDA approval two years ago, shortly after a New England Journal of Medicine (NEJM) report on naltrexone cast doubt on the effectiveness of that drug in combating craving among alcoholics. That report, “Naltrexone in the Treatment of Alcohol Dependence,” appeared in the December 2001 NEJM.
Galanter said he believes that the naltrexone report may have influenced the FDA in its decision to delay approving acamprosate.
The FDA statement announcing the approval of acamprosate, released on July 29, notes that the drug is not addicting and is generally well-tolerated in clinical trials. The most common adverse events reported for patients taking acamprosate included headache, diarrhea, flatulence, and nausea, according to the FDA.
Galanter said that with acamprosate, as with naltrexone and other drugs that have shown promise in reducing alcohol craving, the mechanism of action is largely speculative. Naltrexone is believed to work on the endorphin system; odansetron is believed to work on the serotonergic system.
And Galanter said there is some evidence that the effectiveness of the drugs is increased when they are used in combination.
“The more effective the pill, the more likely the patient is to comply,” he said. “This opens some very interesting options for achieving decreased alcohol use. None of the drugs make them stop drinking, but [these drugs] cut back on craving, reduce the number of people who do drink, and reduce the amount of drinking that people do if they continue to drink. The drugs may,” he said, “have a place for those who are not willing to stop drinking,” but whose drinking has caused serious enough social and medical problems that they are motivated to at least reduce their alcohol intake.
The manual by Galanter and colleagues for training therapists in network therapy can be found online at<www.med.nyu.edu/substanceabuse>.▪
