As reported by the Los Angeles Times, May 3, 2006.

Placebo Is Called Just as Effective as Alcoholism Drug

By Denise Gellene

The drug Campral, approved two years ago to treat alcoholism, works no better than a placebo in reducing the craving for alcohol, according to a study released Tuesday.

The report in the Journal of the American Medical Assn. compared several treatments for alcoholism and found the older generic drug naltrexone offered the clearest benefits.

The study of 1,383 patients at 11 medical centers in the U.S. should spur increased use of naltrexone, which is not widely prescribed, researchers said.

The dominant treatment now is counseling and behavioral therapy, including Alcoholics Anonymous.

"I think results of this kind show that medication has an important place in the treatment array," said Dennis Donovan of the University of Washington and one of the study's 20 authors.

The finding that Campral had no effect was a surprise because the pill seemed to work in other clinical studies. Scientists said more research was needed to sort out the conflicting results.

In a statement, Campral marketer Forest Laboratories Inc. said the study should be viewed as "a single data point."

About 8 million Americans have alcohol dependence, but a minority receive treatment for the disorder. Fewer than 150,000 receive medication for alcoholism. About 75,000 Americans die each year from complications related to alcoholism.

The study looked at various combinations of Campral, naltrexone, behavioral therapy sessions and a placebo pill. Patients received treatment for 16 weeks and were followed for a year after the treatment ended. All the participants said they wanted to quit drinking.

Patients taking either the drugs or a placebo also attended up to nine 20-minute counseling sessions focused on the use of their medication. Patients assigned to behavioral therapy attended as many as 20 50-minute sessions for intensive motivational support.

In addition, all patients were encouraged to participate in Alcoholics Anonymous.

After 16 weeks, researchers assessed the groups based on the ability to abstain from alcohol and avoid heavy drinking, defined as four to five drinks a day.

Patients in all groups, including those taking a placebo, substantially reduced their drinking. Researchers attributed the so-called placebo effect to the optimism on the part of patients about the potential benefits of receiving pills and the effects of regular meetings with doctors and nurses.

Patients taking Campral showed no reduction in craving or the length of time before a relapse involving heavy drinking compared to a placebo, according to the study.

But patients who received naltrexone with counseling showed significant improvement in both of those areas. The patients had twice the chance of achieving a "good outcome" — meaning they were able to abstain or drink in moderation — compared to those on a placebo.

Naltrexone patients also did better than those receiving intensive behavioral therapy.

When researchers looked at patients one year after treatment ended, they found that those who had received naltrexone continued to show a small advantage in preventing a relapse.

In an editorial accompanying the study, Dr. Henry R. Kranzler of the University of Connecticut School of Medicine said the finding suggested treatment should extend beyond 16 weeks for patients to achieve sustained benefits.