- Naltrexone continued to show a small advantage of less relapse to heavy drinking, most markedly in patients who received medical management only but not in those who received specialized alcohol counseling.
- Although a return to at least one heavy drinking day was common during the 1-year follow-up period, overall abstinence was still significantly improved after 1 year (59 to 68 percent PDA) compared with study entry (25 percent PDA).
- Good composite clinical outcomes at 1 year were observed in 38 to 50 percent of patients, with the worst outcomes in patients who received medical management plus placebo and better outcomes in those who received medical management plus either naltrexone or specialized alcohol counseling.
Acamprosate No Better Than Placebo
Also contrary to expectation, the medication acamprosate was shown similar to placebo in this trial."Previous studies have shown that acamprosate alone and in combination with naltrexone can work in settings that reflect clinical practice," Mason said. "The COMBINE trial involved a 4.5-hour intake session and follow-up sessions of up to two hours, as well as contact with up to five specialized staff persons at every visit. This may have increased placebo response such that differences between drugs were very small, even with naltrexone, so I would interpret these outcomes with caution for use in a real-world setting."
Acamprosate Findings 'Perplexing'
In an accompanying editorial in the JAMA publication, Henry R. Kranzler, M.D., of the University of Connecticut School of Medicine, Farmington, commented on the findings of the COMBINE Study:"While this important study provides evidence of the efficacy of some treatments for alcohol dependence, it also raises a number of questions. In view of studies from Europe providing consistent evidence that acamprosate helps to maintain abstinence, the lack of efficacy of this medication in the COMBINE Study is perplexing.
"Although population differences must be considered, differences in study design may have contributed to the lack of replication of the European acamprosate studies. The modest effects of the specific treatments and a lack of additive or synergistic benefits of combining treatments suggest that other compounds and therapeutic approaches should be explored to yield further improvements in the treatment of alcohol dependence."
Widely Available Treatment
"The findings from the COMBINE Study should be of great interest to primary care physicians treating patients with alcohol dependence. Patients who decline an offer of pharmacological treatment to reduce their drinking can be referred for intensive behavioral treatment."Notably, however, the beneficial effects of naltrexone were seen in the context of medical management similar to what is routinely available in primary care practice. This offers the prospect that an efficacious treatment for alcohol dependence can be made as widely available as are current treatments for smoking cessation and major depression."
Part One: Most Effective Alcoholism Treatments
Read More:
Effective Alcohol Dependence Treatments Defined
Particular Treatments Effective for Alcohol Dependence
Study Results Offer Guidance in Treatment
Source: The study "Effect of Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence" appears in the May 2, 2006 issue of the Journal of the American Medical Association, Volume 295, Number 17, pages 2003-2017.
