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Addiction Exchange
News from the worlds of research and clinical practice
Volume 3, No. 7: NIAAA's COMBINE Study
May 1, 2001
Brought to you by FAX, email, and on the web by the Mid-Atlantic
Addiction Technology Transfer Center
Funded by Center for Substance Abuse
Treatment, SAMHSA
Welcome to Addiction Exchange, a forum for the exchange
of clinical practice and research information among clinicians, scientists,
educators, and administrators in the field of addiction.
In this issue, we discuss the National Institute
on Alcohol Abuse and Alcoholism (NIAAA) multisite COMBINE study (Combining
Medications and Behavioral Interventions), a clinical trial researching
treatments for alcohol dependence. COMBINE is the first national study
on alcoholism treatment to evaluate the effectiveness of behavioral treatments
alone and in combination with medications.
Alcohol dependence
“is characterized by an abnormal appetite for alcohol that leads to significant
impairment tolerance, impaired control over intake, physical dependence
and, often, severe craving following sustained abstinence,” according to
NIAAA Director Enoch Gordis, M.D. More than 8 million adults in the U.S.
meet the clinical criteria for alcoholism. As many as half of them relapse
at least once, and only a minority achieve long-term remission of the disease.
Another six million meet the diagnostic criteria for alcohol abuse disorder,
which involves harmful drinking that continues despite life-affecting problems
but does not entail physiological addiction.
The COMBINE
study will take place over the next 24 months at 11 treatment research centers:
the Universities of Washington, Texas, Miami, New Mexico, Pennsylvania,
and Wisconsin-Milwaukee; the Medical University of South Carolina; and Boston,
Yale, Brown and Harvard universities. The University of North Carolina is
the site for the Coordinating Center.
The study,
which will recruit 1,375 people with alcohol dependence, will provide participants
with one or both of two behavioral treatments (moderate intensity and lower
intensity) and one or both of two medications (naltrexone and acamprosate)
or a placebo. Study subjects will attend outpatient sessions for four months,
then return for three followup visits over the following 12 months. All
interventions will include a component supporting compliance to medications
and a reduction in drinking.
The moderate-intensity
behavioral treatment includes motivational enhancement therapy, cognitive-behavioral
skills training and patient involvement in groups such as Alcoholics Anonymous
treatments shown in NIAAA’s Project MATCH to increase abstinent days and
reduce heavy drinking. (Motivational enhancement therapy, based on motivational
psychology, is designed to help patients mobilize personal resources to
effect change. Cognitive-behavioral therapy is based on social learning
theory and is designed to provide skills for avoiding relapse.) The lower-intensity
behavioral treatment is intended to support sobriety and enhance medication
compliance; it is also designed to be incorporated into the daily routine
of health care practitioners.
The FDA-approved
drug naltrexone (Revia), an opioid blocker, interferes with brain neurotransmitter
systems that produce the rewarding effects of alcohol. Researchers have
shown that patients treated with this drug are less likely to relapse to
heavy drinking. Acamprosate (Campral), used in Europe and currently under
review by the FDA, is believed to normalize abnormalities in the neurotransmitter
systems involved in alcohol withdrawal. It may also ease the discomfort
of abstinence, thus helping to prevent drinking. One of the questions the
study will explore is whether treatment effectiveness is improved by pairing
a medication that reduces the risk of any drinking with one that reduces
the risk of heavy drinking.
“COMBINE
is based on the accumulated knowledge of two decades in which NIAAA researchers
have applied rigorous clinical trial methodology to test treatments for
alcoholism,” said Richard K. Fuller, M.D., director of NIAAA’s Division
of Clinical and Prevention Research. In 1996, Project MATCH, another multisite
national trial, demonstrated the effectiveness of involvement in such groups
as AA and of the two behavioral treatments being used in the COMBINE clinical
trial. (See 1996 Project MATCH news release at http://silk.nih.gov/silk/niaaa1/releases/match.htm
on NIAAA’s website.) In addition, neuroscientists have advanced the understanding
of the biology of drinking behavior over the past 10 years. From among the
most promising pharmacologic and behavioral treatments, COMBINE will attempt
to determine the best treatment combinations.
Alcoholism
results from a combination of drinker characteristics, including intrinsic
neurochemical factors (some of which may be genetic) and environmental risk
factors. Brain imaging studies have shown that both medications and behavioral
treatments can influence brain function and resulting behaviors. It is hoped
that this study will show that the behavioral and pharmacological treatments
tested will complement, perhaps even enhance, each other.
NIAAA, an institute of the National Institutes
of Health, conducts over 90 percent of alcohol research in the U.S. for
research on the causes, consequences, prevention and treatment of alcoholism
and alcohol-related problems. For additional information about alcohol research,
visit NIAAA’s website at http://www.niaaa.nih.gov.
Go to http://www.mid-attc.org/wwwboard/wwwboard.shtml
to discuss this topic on the Addiction Exchange Forum.
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Mid-Atlantic Addiction Technology Transfer Center
Funded by Center for Substance Abuse Treatment of
Substance Abuse and Mental Health Services Administration
mid-attc@mindspring.com
http://www.mid-attc.org
804-828-9910
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