Combination Treatments Help Alcoholics Stay Sober

Surprisingly, study found newly approved drug had little effect

TUESDAY, May 2, 2006 (HealthDay News) -- New research suggests that combining medical management with the drug naltrexone, using specialized alcohol therapy, or even trying both strategies at once helps alcoholics stay abstinent about 80 percent of the time.

Surprisingly, the study found the medication acamprosate, which has been used in Europe and was recently approved by the U.S. Food and Drug Administration for the treatment of alcoholism, wasn't effective. At least one expert from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) contends that acamprosate has been shown effective in other studies, and it's likely that it works for some, but not all, people.

"The number one finding is one of optimism. With treatment, people got better. The average across the group went from 12 drinks a day to under two drinks a day," said Dr. Mark Willenbring, director of the NIAAA's Division of Treatment and Recovery Research, said at a press conference Monday. And, he added that many people in the study completely abstained from alcohol.

"If you have a problem, or know someone with a problem, treatment works. Some treatments work better than others, and now we have more choice. People can go to their family doctor [for treatment]," he said.

Results of the study appear in the May 3 issue of the Journal of the American Medical Association.

It's estimated that about 8 million Americans are dependent on alcohol, according to the study. According to Willenbring, only about one-quarter of alcoholics ever try to quit drinking. "This is a serious disorder that is not getting adequately treated," he said.

The current study included nearly 1,400 people who were diagnosed as alcohol-dependent and had already stopped drinking for between four and 21 days.

The study participants were randomized into one of nine treatment groups: medical management and placebo; medical management and acamprosate; medical management and naltrexone; medical management and acamprosate and naltrexone; medical management, specialized therapy and placebo; medical management, specialized therapy and acamprosate; medical management, specialized therapy and naltrexone; medical management; specialized therapy and naltrexone and acamprosate; or specialized therapy alone.

Medical management was delivered by a health-care professional, such as a doctor, nurse or physician's assistant. It included a discussion of the consequences of heavy alcohol intake and advice on stopping drinking. Medical management also included encouragement for attending self-help groups, such as Alcoholics Anonymous. Follow-up visits, lasting an average of 20 minutes each, reviewed drinking history and provided additional encouragement.

Specialized therapy, dubbed Combined Behavioral Intervention (CBI), was provided by a mental health-care specialist, such as a psychologist or social worker. This therapy included aspects of cognitive behavioral therapy, motivation, parts of the 12-step program and a support system. Study participants who received CBI had as many as 20 sessions.

The study participants were assessed for drinking behavior at 16 weeks, and then again a year later.

During the treatment phase of the study, the researchers found that medical management combined with naltrexone alone, CBI plus placebo, or CBI alone were the most effective treatments, allowing alcoholics to stay abstinent about 80 percent of the time.

Acamprosate didn't perform better than placebo, even when it was combined with naltrexone.

"We found no evidence of efficacy for acamprosate, and also no evidence of incremental efficacy for combinations of naltrexone, acamprosate and CBI. Somewhat unexpectedly, we observed a positive effect of receiving placebo medication and medical management," wrote the study's authors.

Willenbring said that past studies on acamprosate done in Europe have found a benefit from this medication, and he suspects there is probably a subgroup of people that benefit from this drug. The researchers will be reviewing the acamprosate data to see if there is a group of people who were helped by acamprosate. Like antidepressant medications, Willenbring said that people with alcohol dependence may need to try more than one drug to find the one that works.

"I was surprised that there was no effect greater than placebo for acamprosate, and I was also surprised at the magnitude of the placebo affect," said Dr. Henry Kranzler, a professor of psychiatry at the University of Connecticut School of Medicine and author of an accompanying editorial.

He said the strong placebo effect may have something to do with the way the study volunteers are recruited. These people were already abstinent, and likely highly motivated to succeed.

He said there's definitely still a place for acamprosate in alcoholism treatment because it has been effective in other trials. "Clinical trials aren't perfect. Not too long ago, a major study from the VA showed that naltrexone had no effect," he pointed out.

With any of these treatments, he said, "the effects aren't huge effects." But, they can help people who are motivated to stop drinking.

"Naltrexone is not the alcoholism pill. It's a medication that helps people reduce their risk of drinking. It's not a magic bullet," said Kranzler.

After a year, there wasn't a significant difference between the groups. On average, the groups had between 75 and 80 days completely abstinent. The CBI group only managed 67 abstinent days. Willenbring said findings may suggest the need for maintenance treatment, similar to that of other chronic diseases.

More information

Read this article from the American Academy of Family Physician's if you think you or someone you love has a drinking problem.

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