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
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
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>.▪