About 8 million individuals in the U.S. currently meet diagnostic criteria for alcohol dependence ( also called alcoholism ), a leading preventable cause of illness and death and a major contributor to health care costs.
In primary care settings, the prevalence of alcohol use disorders ranges from 20 to 36%; most of those patients are never treated and, if they are, do not receive specialty care. Several behavioral treatments and at least two medications approved by the FDA ( Food and Drug Administration ), Naltrexone ( Vivitrol ) and Acamprosate ( Campral ), have shown efficacy in the treatment of alcohol dependence. However, no large-scale randomized controlled study has evaluated whether combined drug treatment with or without behavioral therapy could improve outcome.
Raymond F. Anton, of the Medical University of South Carolina, Charleston, and colleagues evaluated the effectiveness in treating alcohol dependence with medical management and Naltrexone, Acamprosate, or both, with or without combined behavioral intervention ( CBI ) provided by behavioral health specialists.
The trial ( COMBINE Study ), conducted from January 2001 January 2004, included 1,383 recently alcohol-abstinent volunteers with a diagnosis of primary alcohol dependence. The participants were divided into 9 groups. Eight groups of patients received medical management with 16 weeks of Naltrexone or Acamprosate, both, and/or both placebos, with or without CBI. Medical management included sessions with a medical professional focused on enhancing medication adherence and alcohol abstinence. A ninth group received combined behavioral intervention only. Patients were evaluated for up to one year after treatment.
The researchers found that all groups showed substantial reduction in drinking. During treatment, patients receiving Naltrexone plus medical management, CBI plus medical management and placebos, or both Naltrexone and CBI plus medical management had higher percentages of days abstinent ( 80.6, 79.2, and 77.1, respectively ) than the 75.1 in those receiving placebos and medical management only. Naltrexone also reduced the risk of a heavy drinking day over time, most evident in those receiving medical management but not combined behavioral intervention.
Acamprosate showed no significant effect on drinking compared with placebo, either by itself or with any combination of Naltrexone, combined behavioral intervention, or both. During the 16 weeks of treatment, there was an overall difference in percent days abstinent between those receiving placebo pills and medical management alone ( 73.8 ), placebo pills and medical management plus combined behavioral intervention ( 79.8 ), and CBI alone ( 66.6 ). One year after treatment, these between-group effects were similar but no longer significant.
In conclusion, within the context of medical management, Naltrexone yielded outcomes similar to those obtained from specialist behavioral treatment. Researchers found no evidence of efficacy for Acamprosate and also no evidence of incremental efficacy for combinations of Naltrexone, Acamprosate, and combined behavioral intervention.
Somewhat unexpectedly, researchers observed a positive effect of receiving placebo medication and medical management over and above that seen with specialist-delivered behavioral therapy alone. Medical management of alcohol dependence with Naltrexone appears to be feasible and, if implemented in primary, and other, health care settings, could greatly extend patient access to effective treatment.
Source: Journal of the American Medical Association, 2006