A medication that is currently approved to treat Restless Legs Syndrome will undergo a clinical trial for use in the treatment of alcohol-use disorder.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is part of the NIH, will conduct a clinical trial of gabapentin enacarbil (Horizant). The trial is expected to start in the first half of 2015 and enroll a total of 350 patients.
Alcohol-use disorders affect about 17 million people in the United States and have an estimated societal cost of $223.5 billion each year, primarily from lost productivity, but also from health care and property damage costs.
“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,” George F. Koob, PhD, director of the NIAAA, said.
“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," he added.
Three medications are currently approved by the FDA for treating alcohol dependence: disulfram, acamprosate and naltrexone.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will conduct 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 enroll approximately 350 participants.
The study 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.