May 2, 2006 -- A widely ignored drug was found to help alcoholics stop drinking, while a newer medication did not seem to be effective in a large, widely anticipated study of treatments for alcohol dependence.
Results from the trial are published in the May 3 issue of the Journal of the American Medical Association.
Seeing a doctor or nurse regularly to discuss treatment issues also seemed to help patients on the road to recovery. Researcher Raymond F. Anton, MD, tells WebMD that the study findings show that effective alcohol treatments can be delivered in the general care medical setting.
"I think a lot of physicians think they have nothing to offer alcoholics, and this study shows this is not true," Anton says. "It is clear that motivated people who seek treatment can do well. And there are tools that primary care doctors can use to help them."
Millions Could Benefit
As many as 8 million people in the United States meet the diagnostic criteria for alcohol dependence, but only a small percentage of them ever seek treatment, Anton says.
The study did not include patients treated in in-patient hospital or private care settings. It also did not measure the impact of 12-step programs like Alcoholics Anonymous, although participation in these programs was encouraged and 20% to 30% of the study participants did attend AA meetings, Anton says.
Instead, the researchers focused on established outpatient treatments that could be delivered by health care professionals, including behavioral therapists.
All of the roughly 1,400 patients in the study had abstained from alcohol for at least four days when randomly assigned to one of the nine treatment groups encompassing various combinations of drug treatment, medical management, and targeted behavioral therapy.
Eight of the groups received medical management, which included nine brief meetings with a nurse or their doctor to discuss treatment. Some also got more intensive cognitive behavioral therapy, delivered by therapists specially trained in. The aim of cognitive behavioral therapy was to teach patients specific coping skills to help them. One group got cognitive behavioral therapy alone without any pills or medical management.
Most of the patients were treated with some form of drug therapy. This included either the drug naltrexone (ReVia), which was approved by the FDA for promoting alcohol abstinence in 1994, the drug acamprosate (Campral), approved for the same purpose in 2004, or a combination of the two drugs. Both medications are used to help decrease the urge to drink alcohol.
80% Decline in Drinking
Patients received active treatment for 16 weeks, and they were followed for up to a year once therapy ended.
Among the study's major findings:
- Overall, alcohol consumption decreased by 80% during the 16 weeks of treatment, and all the treatments were well tolerated.
- Treatment with naltrexone significantly decreased the likelihood of heavy drinking and increased the number of days without drinking, even in the absence of cognitive behavioral therapy.
- Treatment with acamprosate offered no treatment advantage over placebo treatment, even when it was used in combination with naltrexone, cognitive behavioral therapy, or both.
- Behavioral therapy was as effective as treating patients with naltrexone alone. But combining the two treatments appeared to offer no treatment advantage over either approach delivered alone.
- The patients who got cognitive behavioral therapy alone with no pills had less improvement than those who took placebo pills.
Drug and alcohol treatment expert Henry R. Kranzler, MD, of the University of Connecticut School of Medicine, says the finding points to a strong placebo effect in the treatment of alcohol dependence.
Kranzler tells WebMD that the study also sends a clear message that naltrexone is the first-line drug therapy for the treatment of alcohol dependence.
"Right now, if physicians are prescribing drugs they are probably prescribing SSRI antidepressants," he says. "They should be prescribing naltrexone."
The study also sends the message that there is more than one effective treatment approach for alcohol dependence.
While studies show that intensive group treatment programs like Alcoholics Anonymous can be very effective, many people struggling withwant little to do with group therapy, he says.
"Alcohol-dependent people are very heterogeneous with regard to how they view their drinking and how they would like to approach treatment," he says. "But it is clear that if they are motivated to get help they can get better."