(Philadelphia, PA) - According to a study that
appears in the current issue of the Journal of the American
Medical Association, researchers at the University
of Pennsylvania School of Medicine and 10 other sites found
that the medication naltrexone, when delivered with structured medical
management, or specialized alcohol counseling by a behavioral specialist
are equally effective treatments for alcohol dependence.
Results from the National Institutes of Health (NIH)-supported
study - "Combining Medications and Behavioral Interventions
for Alcoholism" (COMBINE) - show that patients who received
naltrexone, specialized alcohol counseling, or both demonstrated
the best drinking outcomes after 16 weeks of outpatient treatment.
All patients also received Medical Management (MM), an intervention
consisting of nine brief, structured outpatient sessions provided
by a medical health care professional. Contrary to expectations,
the researchers also found that the medication acamprosate had no
effect on drinking and showed no benefit in combination with naltrexone.
"We are thrilled to have data from the largest government-sponsored
pharmacotherapy study of alcohol dependence that has been done to-date
that show how a medically-oriented treatment approach can be effective
in treating alcohol disorders," said Dr. Helen M. Pettinati,
Principal Investigator at Penn, and Professor and Division Director
of Penn's Treatment Research Center (TRC).
NIH's National Institute on Alcohol Abuse and Alcoholism (NIAAA)
launched COMBINE in 2001 to identify the most effective current
treatments and treatment combinations for alcohol dependence. The
largest clinical trial ever conducted of pharmacologic and behavioral
treatments for alcohol dependence, COMBINE was conducted at 11 academic
sites that recruited and randomly assigned 1,383 recently-abstinent,
alcohol-dependent patients to one of nine treatment groups. Eight
treatment groups received MM plus medications or placebo: naltrexone
(100 milligrams a day), acamprosate (3 grams a day), both naltrexone
and acamprosate, or placebo pills. Four of the eight groups also
received Combined Behavioral Intervention (CBI) - specialized alcohol
counseling that integrated cognitive-behavioral therapy, motivational
enhancement, and techniques to enhance mutual help group participation.
Patients assigned to the specialized alcohol counseling could receive
up to twenty 50-minute sessions in addition to medical management.
To test for any effects of pill taking (placebo), the researchers
assigned some patients to a ninth group that received specialized
alcohol counseling, but no pills, and no more than four visits with
a health professional for general medical advice.
During the 16 weeks of treatment and one year after the treatment,
the researchers assessed the patients for the percentage of days
abstinent from alcohol and time to the first heavy drinking day,
defined as four or more drinks per day for women and five or more
drinks per day for men. They also assessed the odds of good clinical
outcome, defined as abstinence or moderate drinking without alcohol-related
problems. As in other large clinical trials, the researchers found
that most patients showed substantial improvement during treatment
and that both the overall level of improvement and the differences
among treatment groups diminished during the follow-up period. In
the COMBINE study, however, naltrexone continued to show a small
advantage for preventing relapse at one year after the end of active
"Alcoholism is a serious disease that destroys lives,”
says Pettinati. “These findings indicate that alcoholism can
be treated in a medical setting, giving more people who struggle
with an alcohol problem an alternative way to get treatment.”
About the Treatment Research Center
The Treatment Research Center (TRC) at the University of Pennsylvania
School of Medicine is an outpatient alcohol and drug treatment and
research facility that is funded primarily by federal grants. The
treatment provided at the TRC includes various types of counseling
and the use of medications for detoxification, craving reduction
and relapse prevention. Ongoing at the TRC are a number of treatment
studies for alcohol, cocaine and nicotine dependence, including
naltrexone, medication management, and Combined Behavioral Intervention
(CBI). For more information or to schedule an appointment, call
PENN Medicine is a $2.9 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 #2 in the nation for receipt
of NIH research funds; and ranked #3 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 medicine.
The University of Pennsylvania Health System includes three
hospitals [Hospital of the University of Pennsylvania, which is
consistently ranked one of the nation's few "Honor Roll"
hospitals by U.S.News & World Report; Pennsylvania Hospital,
the nation's first hospital; and Penn Presbyterian Medical Center];
a faculty practice plan; a primary-care provider network; two multispecialty
satellite facilities; and home care and hospice.