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May 19, 2006|Volume 34, Number 29|Three-Week Issue


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Study confirms usefulness of naltrexone in medical management of alcohol dependence

The medication naltrexone or up to 20 sessions of alcohol counseling with a behavioral specialist are equally effective treatments for alcohol dependence when delivered with structured medical management, according to a multi-center study that included the School of Medicine.

The "Combining Medications and Behavioral Interventions for Alcoholism" (COMBINE) Study monitored patients for 16 weeks and then one year. All of the patients received Medical Management (MM), an intervention that consists of nine brief, structured outpatient sessions provided by a health care professional.

The former chair of the trial, Stephanie O'Malley, professor in the Department of Psychiatry, conducted one of the two original efficacy studies on which naltrexone was approved by the Food and Drug Administration for the treatment of alcoholism. The COMBINE Study, funded by the National Institute on Alcohol Abuse and Alcoholism (NIAA), was carried out at 11 academic sites. Nearly 1,400 recently abstinent alcohol dependent patients were recruited and randomly assigned to one of nine treatment groups.

The results were published recently in the Journal of the American Medical Association.

Patients in eight of the groups received MM in which they attended sessions with a physician, nurse, physician assistant or pharmacist and received 100 milligrams a day of naltrexone or three grams daily of acamprosate, or both medications or a placebo.

In addition to MM, some of the groups also received specialized alcohol counseling. This counseling, which is known as Combined Behavioral Intervention (CBI), includes cognitive behavioral therapy, motivational enhancement and techniques to enhance mutual help group participation. Some patients were assigned to a group that received CBI, but no medication.

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 when they had their first heavy drinking day, which was defined as four or more drinks per day for women and five drinks daily for men. The researchers also assessed the odds of a good clinical outcome, which was 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. However, naltrexone reduced the risk of heavy drinking overall. Either naltrexone or CBI in combination with MM increased the percentage of days abstinent and the odds of a good clinical outcome compared to MM with placebo. Although the overall level of improvement and the differences between treatment groups diminished during the follow up period, naltrexone continued to show a small advantage for preventing relapse at one year after the end of active treatment. Contrary to expectations based on previously published studies outside of the United States, the researchers found no effect on drinking of the medication acamprosate and no additive benefit from adding acamprosate to naltrexone.

Dr. Mark Willenbring, director of the NIAA's Division of Treatment and Recovery Research, says families and prospective patients can be assured by the results that either naltrexone or specialized alcohol counseling in the context of MM is an effective option for treating alcohol dependence.

"Currently, about 9 in 10 patients with alcohol dependence do not receive professional treatment," says Willenbring. "Medical Management is a strategy that potentially could be implemented in a variety of health care settings, such as primary care and general mental health care. This would expand access to effective treatment dramatically, while offering patients greater choice."

O'Malley says COMBINE patients who received CBI experienced more days of abstinence during the year following treatment, although this was not statistically
significant.

"This may be because CBI teaches specific skills that patients can continue to use following therapy," she says. "In general, however, the small long-term difference among COMBINE groups suggests that some people with alcohol dependence may benefit from prolonged or intermittent care. Primary health care providers are in an excellent position to monitor and coordinate patient care because of their ongoing relationship with the patient."

Dr. Patrick O'Connor, professor of medicine and chief of the Section of General Internal Medicine at Yale, noted that this trial supported the results of an earlier trial he and O'Malley performed with others which suggested that naltrexone plus MM could be an effective treatment for many patients.

"The treatment approaches used in COMBINE and in our earlier work give strong support to the notion that patients with alcohol dependence can be effectively treated in primary care settings," says O'Connor. "The opportunity to receive this treatment under the care of a primary care physician means that many patients who will not go to specialty treatment program will get have a viable option for getting help with their problem drinking. The approach of naltrexone plus Medical Management is well within the skill set of most primary care physicians and can easily be adapted with appropriate training."

-- By Jacqueline Weaver


T H I SW E E K ' SS T O R I E S

Scientists identify new genus of monkey; first in 83 years

Divinity Dean reappointed to second term

Yale to celebrate 305th Commencement

Student photographs 'hidden beauty in everyday life'

Summertime at Yale

Brownell cited as one of world's '100 most influential people'

President Levin honored for increasing town-gown partnerships

ENDOWED PROFESSORSHIPS

Four individuals will bring their expertise . . . to SOM

Two noted violinists . . . join the faculty of the School of Music

Three residential college masters named to second term
Laura Cruickshank named to post of University planner

Exhibit features English silver pieces once owned by tsars

Exhibits look back at 40 years of chiming bells and more

Major renovation effort begins at Cross Campus Librar

MEDICAL SCHOOL NEWS

Eight graduating seniors are bound for China as teaching fellows

IN MEMORIAM

Yale's nurse-midwives celebrate 50 years of community care

Talk will focus on life extension and human right

'Keepers of the Dream' to look at advancing urban education

Sociologist Adams honored for book on 'The Familial State'

Association honors Yale-affiliated scientists and engineers . . .

Journal of Industrial Ecology marks two milestones . . .

Grant will fund research on how human speech is shaped

'Trouble in Tahiti' to be performed during School of Music alumni weekend

Campaign invites community to 'Plant a Row for the Hungry'

Campus Notes


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