A complex study of alcoholism treatment medications and counseling has found that most standalone and combined therapies were effective in promoting short-term abstinence, with only the drug acamprosate (Campral) proving to be disappointing.
The three-year COMBINE study, funded by the National Institute on Alcohol Abuse and Alcoholism, involved 1,383 subjects who were diagnosed as alcohol-dependent and had recently quit drinking. Patients were broken into smaller study groups, including those who received 16 weeks of naltrexone (100 mg/d) or acamprosate (3 g/d), both, with or without placebos, and with or without a combined behavioral intervention (CBI).
One group received CBI only, with no pills. Some groups also received medication management — counseling to ensure that patients took their medication and remained abstinent from alcohol.
A four-month evaluation found that all groups demonstrated reduced drinking. The best results were found among those who received naltrexone (ReVia) and medication management, who stayed abstinent 80.6 percent of the days in the study period. Also found highly effective were CBI plus medical management and placebos (79.2 percent) and naltrexone and CBI plus medical management (77.1 percent).
However, “Acamprosate showed no significant effect on drinking vs. placebo, either by itself or with any combination of naltrexone, CBI, or both,” according to the study published in the May 3, 2006 issue of the Journal of the American Medical Association (JAMA). (An accompanying editorial in JAMA questioned this finding, noting that previous European studies have found that acamprosate does promote abstinence.)
“We were surprised by two findings from our study. One was that acamprosate was no more effective than placebo alone, and two, that while naltrexone was effective in its own right, combining it with the specialized counseling added no more effectiveness than naltrexone by itself,” study author Raymond Anton of the Medical University of South Carolina told Reuters.
“No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management,” the study concluded, noting that, “Naltrexone with medical management could be delivered in healthcare settings, thus serving alcohol-dependent patients who might otherwise not receive treatment.”
Mark Willenbring, director of treatment and recovery research at NIAAA, told the Associated Press that the study “really does open up the possibility of people having more choice, and it could significantly expand access.”
However, some critics questioned the value of the study, noting that participants — unlike most alcoholics — were highly motivated to quit.
Some also said that four months was too short a study period to determine treatment efficacy. Stuart Gitlow, an addiction specialist at Mount Sinai School of Medicine, said such short-term measures were “worthless.”
The research also did not report how many subjects remained entirely abstinent, although it showed that about half still had their drinking under control after a year. “What happens is that, after treatment is over, a certain number of people relapse,” Anton told the New York Times. “And like many chronic conditions, the farther out you go, the more people relapse.”
But to Gitlow, the bottom line is, “Either you drink or you don’t. Alcoholism is like pregnancy: you are or you’re not. No middle ground.”
A one-year follow-up study by the COMBINE researchers did show that the patients treated with medications tended to remain abstinent for more days than the placebo-only patients, and that those who received CBI did better than those who had only received medication management.
“This study and others have shown that people should be optimistic about treatment for their alcohol problems, that treatment does work,” Anton told Reuters.
Experts who spoke with the Times, however, acknowledged that the study participants spent far more time with healthcare professionals than the typical addiction-treatment client does.
“What the study shows is that it doesn’t seem to matter much what kind of treatment you get, as long as you get an approach with a good rationale,” Edward Nunes, a professor of clinical psychiatry at Columbia University, told the Times. “Most people in the study reduced their drinking significantly.”