Injectable Drug, Combined with Counseling, Shows
Promise in Treating Alcohol Dependence
(Philadelphia, PA) -- Alcohol dependence is a major public health problem,
ranking as the fourth leading cause of disability worldwide, according
to the World Health Organization’s Global Burden of Disease project.
In the United States, it is believed to contribute to more than 100,000
preventable deaths a year. Now, researchers from the University
of Pennsylvania School of Medicine, in conjunction with 23 other
sites nationwide, have found that long-acting injections of the drug naltrexone,
when added to counseling, significantly reduced heavy drinking in patients
being treated for alcohol dependence.
Study results show 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. The results will be published in the April
6 issue of the Journal of the American Medical Association.
“It is so important that our field find new treatments for alcohol
dependence,” says Helen Pettinati, PhD, Research
Professor in Penn’s Department of Psychiatry, Director, Treatment
Research Division in the Center for the Study of Addictions, and lead
investigator for Penn’s component of the trial. “Long-acting
naltrexone represents a promising new development for treatment, and I
hope that it can play a role in helping the large number of individuals
in the U.S. who suffer from alcohol dependence.”
Naltrexone was approved in pill form by the U.S. Food and Drug Administration
in 1994 for treating alcohol dependence. It belongs to a class of drugs
called opioid antagonists, for treating alcohol dependence. Although many
clinical trials have shown that oral naltrexone can be effective in treating
alcohol dependence, its use in clinical practice has been limited, in
part because the drug was given as a pill that patients have to take daily.
“Alcoholism is a serious disease that destroys lives. As we learn
more about how the brain is affected by alcohol, we are discovering how
best to provide treatment -- like adding a safe medication to counseling.
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.
A total of 627 alcohol-dependent patients were randomly assigned to receive
either an injection of long-acting naltrexone or a placebo injection;
624 ultimately received at least one injection. In addition to an injection,
all participants received low-intensity counseling consisting of 12 sessions
during the six-month study, in addition to study medication. Long-acting
naltrexone was associated with a reduction in heavy drinking within the
first month of treatment, and this response was maintained over the six-month
treatment period. In addition, long-acting naltrexone was generally well
tolerated and side effects were predominantly mild and decreased over
time. (The three most common side effects reported were nausea, headache
The study was one of the largest trials of a medication for alcohol dependence
and was conducted at 24 sites nationwide, including public, private hospitals
and Veterans Administration clinics and tertiary-care medical centers.
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.
This study was funded by Alkermes Incorporated. Dr. Pettinati received
research support from Alkermes to conduct this study at Penn, and she
also is an external advisor to the company.
Persons with alcohol and drug dependence who are interested in obtaining
no-cost treatment in a clinical trial should call Penn’s Treatment
Research Center at the 215-243-9959.
PENN Medicine is a $2.7 billion enterprise dedicated
to the related missions of medical education, biomedical research, and
high-quality patient care. PENN Medicine consists of the University of
Pennsylvania School of Medicine (founded in 1765 as the nation’s
first medical school) and the University of Pennsylvania Health System.
Penn’s School of Medicine is ranked #3 in the nation for receipt
of NIH research funds; and ranked #4 in the nation in U.S. News &
World Report’s most recent ranking of top research-oriented medical
schools. Supporting 1,400 fulltime faculty and 700 students, the School
of Medicine is recognized worldwide for its superior education and training
of the next generation of physician-scientists and leaders of academic
Penn Health System is comprised of: its flagship hospital, the Hospital
of the University of Pennsylvania, consistently rated one of the nation’s
“Honor Roll” hospitals by U.S. News & World Report; Pennsylvania
Hospital, the nation's first hospital; Presbyterian Medical Center; a
faculty practice plan; a primary-care provider network; two multispecialty
satellite facilities; and home health care and hospice.