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Clinical trial planned for alcohol use disorder drug

The National Institute on Alcohol Abuse and Alcoholism, part of the NIH, recently announced plans to conduct a clinical trial of gabapentin enacarbil as a potential treatment for alcohol use disorder, according to a release from the institute.

“Current medications for alcohol dependence are effective for some, but not all, patients,” George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), said in the release. “New medications are needed to provide effective therapy to a broader spectrum of alcohol dependent individuals. Prior clinical studies of gabapentin, the active metabolite of the molecule called gabapentin enacarbil, have shown positive results in patients with [alcohol use disorder]. We believe that the time is right to conduct a multi-site, well-controlled clinical trial.”

The safety and efficacy of gabapentin enacarbil (Horizant, XenoPort) will be examined among people who have been diagnosed with alcohol use disorder. The study will be a randomized, double blind, placebo-controlled, 6-month clinical trial, beginning in the first half of 2015. An estimated 350 participants will be included.

In recent study data supported by NIAAA, compared with participants taking placebo, participants taking gabapentin enacarbil were more likely to stop drinking or refrain from heavy drinking.

The study drug will be supplied by XenoPort Inc., and NIAAA is working in partnership with them.