Data from DrugAbuse Sciences' (DAS) 12-month Phase III clinical trial of Naltrexone Depot for treatment of alcoholism suggested that patients treated with Naltrexone Depot experience a long-term reduction in drinking in comparison to the placebo group. The results indicated that patients treated with Naltrexone Depot experienced 73% more drink-free days than their placebo group counterparts.
This unprecedented information is crucial in the addiction treatment field," stated Dr. Henry Kranzler, from the University of Connecticut School of Medicine, who was principal investigator in the trial. "No other medication has been shown to assist patients in becoming abstinent from alcohol for such a considerable period of time."
Naltrexone Depot is a once per month injection that is currently being investigated for treating alcoholism. Patients from 29 alcohol treatment centers throughout the United States were enrolled in the trial. The average patient age was 44 years and each patient had at least a 10-year history of alcoholism. All patients received counseling, which included motivational enhancement therapy sessions provided during the first 12 weeks of the study. On an intent-to-treat basis, at 3, 6 and 12 months, those patients who received Naltrexone Depot had significantly more drink-free days (10%, 20% and 73%, respectively) than patients in the placebo group. The increase in drink-free days over time reached a p-value of 0.0001 by 12 months.
"Short-term studies have shown that the naltrexone tablet can help people reduce the amount they drink, or even quit drinking, if they are compliant. However, no long-term studies have shown positive results," reported Dr. Donald Wesson, who designed the DAS Naltrexone Depot trial. "Naltrexone Depot was formulated to address issues with compliance. The intent-to-treat analyses of this long-term study imply that Naltrexone Depot has a pharmacological benefit which appears to increase over time and aids in abstinence."
"We are encouraged that these results will positively impact the treatment of alcoholism," says Chairman and CEO, Elizabeth M. Greetham. "The data reinforces DAS' belief that pharmacotherapy delivered in user-friendly formulations will contribute significantly to the treatment of addiction."