NIAAA Plans Clinical Trial for Alcohol Abuse Disorder

Sep 09, 2014


The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has scheduled a clinical trial of gabapentin enacarbil as a potential treatment for alcohol use disorder (AUD). NIAAA estimates that the six-month trial will begin in the first half of 2015 and will include about 350 participants. The study will be a randomized, double-blind, placebo-controlled clinical trial.

The trial will assess the safety and efficacy of gabapentin enacarbil in people who have been diagnosed with AUD. NIAAA is working in partnership with the biopharmaceutical company XenoPort Inc., of Santa Clara, California, which will supply the study drug. Gabapentin is already widely prescribed to treat pain conditions and epilepsy.

“Current medications for alcohol dependence are effective for some, but not all, patients. New medications are needed to provide effective therapy to a broader spectrum of alcohol dependent individuals,” said George F. Koob, Ph.D., director of the NIAAA, a part of the National Institutes of Health. “Prior clinical studies of gabapentin, the active metabolite of the molecule called gabapentin enacarbil, have shown positive results in patients with AUD. We believe that the time is right to conduct a multi-site, well-controlled clinical trial.”

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