A new Journal of the American Medical Association ($) article (abstract here) described in this summary reports on a once-monthly, injectable medication that has been shown to reduce heavy drinking substantially among alcoholics.
The drug is a formulation of naltrexone, a drug that is currently approved to treat alcohol dependence. However, the drug is currently rarely prescribed because it must be taken daily, which most alcoholics simply will not do. Cambridge, Mass.-based Alkermes Inc. filed an application with the Food and Drug Administration earlier this month to approve the drug, which will be known under its brand name of Vivitrex. According to the study, Vivitrex — which must be taken only monthly — has the “potential to improve intervention strategies for alcohol dependence.” Alkermes funded the JAMA-Vivitrex study and the development of the drug was supported by a grant from the National Institute on Alcohol Abuse and Alcoholism, a unit of the National Institutes of Health.
The NIAAA estimates that up to 18 million Americans have an alcohol-related disorder. Alcohol dependence is defined as women who consume four or more drinks a day on a regular basis and men who consume five or more drinks, which researchers used to define a “heavy drinking” day in the JAMA study involving Vivitrex.
James C. Garbutt of the University of North Carolina at Chapel Hill headed up the study, which involved 624 alcoholic adults. The patients received either an intramuscular injection of 380 milligrams of Vivitrex, 190 milligrams of Vivitrex, or a placebo (i.e., a fake injection), and all of the patients received counseling. Overall, the study showed that the number of “heavy drinking” days was cut by 25%, a drop that researchers deemed “significant” among those using the highest dose of the drug.