According to the World Health Organization's Global Burden of Disease project, alcohol dependence, a major public health problem, ranks fourth as one of the worlds leading cause of disability. In the US alone over 100,000 deaths each year, where alcohol was a contributing factor, could have been prevented.
New research from the University of Pennsylvania School of Medicine, in conjunction with 23 other sites nationwide, has found that long-acting injections of the drug naltrexone, when used in conjunction with counselling, significantly reduces heavy drinking in patients being treated for alcohol dependence.
The research found that the median number of heavy-drinking days was reduced from 19 days in the month prior to the study to three days per month over the six months of treatment.
Naltrexone, approved in pill form by the U.S. Food and Drug Administration in 1994 for treating alcohol dependence, belongs to a class of drugs called opioid antagonists, and previous clinical trials show that oral naltrexone can be effective in treating alcohol dependence, but because the drug was given as a pill that patients have to take daily its use in clinical practice has been limited.
In the six-month study 627 alcohol-dependent patients were randomly assigned to receive either an injection of long-acting naltrexone or a placebo injection; 624 received at least one injection. In addition to an injection, all received 12 sessions of low-intensity counselling in addition to study medication.
Within the first month of treatment a reduction in heavy drinking was seen, and was maintained over the six-month treatment period. The drug was generally well tolerated with only mild side effects, the most common were nausea, headache and fatigue, which decreased over time.
Helen Pettinati, PhD, Research Professor in Penn's Department of Psychiatry, Director, Treatment Research Division in the Centre for the Study of Addictions, and lead investigator for Penn's component of the trial, says that long-acting naltrexone represents a promising new development in the treatment of alcohol dependence and she hopes that will help the large number in the U.S. who suffer from alcohol dependence.
Dr. Pettinati says alcoholism is a serious disease that destroys lives and as more is learnt about the effect of alcohol on the brain, it will be discovered what the best to treatment is, such as adding a safe medication to counselling. "A long-acting injectable, which eliminates the burden of daily pill taking, will open new doors for our patients and give hope to them and their families," adds Dr. Pettinati.
The study, one of the largest trials of a medication for alcohol dependence, was conducted at 24 sites nationwide, including public, private hospitals and Veterans Administration clinics and tertiary-care medical centres. Other study authors included researchers from the medical schools at the University of Connecticut, Yale University, and Harvard University, and from Alkermes Incorporated, a biotechnology company based in Cambridge, Mass., that manufactures the long-acting naltrexone formulation (Vivitrex) used in the study.
The results will be published in the April 6 issue of the Journal of the American Medical Association.