• Psychiatry Clinical Trials
• Substance-Related Disorders

In the latest update on the COMBINE Trial, a multicenter, treatment comparison study funded by the National Institute on Alcohol and Alcohol Abuse (NIAAA), leading alcohol researchers gathered to present the most recent findings from this collaborative project.

Briefly, the purpose of the COMBINE Trial has been to evaluate the effectiveness of behavioral management techniques, pharmacological interventions, and combinations of the two methods in the treatment of alcoholism. The rationale for which was the mounting evidence suggesting that these modes of treatment may actually enhance one another, thus, decreasing the likelihood of relapse in the recovering alcoholic. The behavioral treatment conditions included Medical Management Therapy (a brief motivational-based treatment), Combined Behavioral Intervention (CBI; a combination of Cognitive Behavioral Therapy, Motivational Enhancement Therapy and Twelve-Step Facilitation) plus Medical Management Therapy, as well as CBI alone. The drugs evaluated alone or in combination with these therapies were naltrexone and acamprosate. Treatment lasted for 16 weeks. The primary outcome measures utilized were “percent days abstinent” and “time to relapse”.

Summarizing the latest findings (Anton et al. JAMA 2007; 297:2003–2017), Robert Swift, MD, PhD, Brown University, not only noted small attrition rates, but indicated that, in the context of abstinence, most participants did well independent of the particular treatment condition to which they were randomly assigned. In fact, Dr. Swift noted a 45% mean increase in days abstinent over the course of the trial. Looking at the particular treatments, there appeared to be no significant difference in days abstinent between those patients who were on either acamprosate or naltrexone versus placebo. For “time to relapse”, patients on naltrexone fared better than those taking acamprosate or placebo. In the context of therapy, no benefit was apparent in participants undergoing CBI plus Medical Management Therapy versus Medical Management Therapy alone. When looking at the particular combination of treatments, no benefit was reported in those groups taking naltrexone in combination with acamprosate, or undergoing CBI while taking acamprosate. There was however, an increase in percent days abstinent in those patients taking naltrexone in combination with Medical Management Therapy only. Dr. Swift notes, these patients “did the best”, although the treatment effects were modest.

Allen Zweben, PhD, Columbia University, noted that treatment effects seen in the COMBINE trial could not be accounted for strictly based on treatment adherence rates, though 12-step program participation was higher with patients undergoing Medical Management Therapy. Still, patients taking acamprosate showed lower adherence rates than those individuals taking naltrexone only.

Overall, the Director of NIAAA's Treatment and Recovery Research unit, Mark Willenbring, MD, was encouraged by the latest round of findings. Medical Management Therapy in conjunction with naltrexone is has shown to be an effective practice when treating individuals with alcohol problems. The clinical utility of this mode of treatment is that it is more accessible than traditional mental health service to many individuals. It can not only be used by the mental health professional, but the general practitioner as well. NIAAA has now published a step-by-step guide for the general practitioner to treat alcoholics using Medical Management Therapy. This guide is available on their website at www.niaaa.nih.gov.

• © 2007 MD Conference Express