The National Institute of Alcohol Abuse and Alcoholism (NIAAA) announced the initiation of a clinical trial to evaluate the safety and efficacy of gabapentin enacarbil as a potential treatment for alcohol use disorder.
The multi-site, randomized, double-blind, placebo-controlled study will enroll 346 patients with alcohol use disorder at 10 sites across the country. Patients will be randomized to gabapentin enacarbil 1200mg or placebo for 26 weeks and will be assessed for the reduction in drinking in those who with ≥4 symptoms of alcohol use disorder. The study will determine whether patients taking the study drug are more likely to abstain from heavy drinking during the final four weeks of treatment.
Researchers from the Scripps Institute had found in a previous study that alcohol dependent patients who took gabapentin were more likely to stop drinking or refrain from heavy drinking vs. patients who took placebo. Currently, the Food and Drug Administration (FDA) has approved three treatments for alcohol dependence: disulfiram, acamprosate, and naltrexone.
Gabapentin enacarbil is a prodrug of gabapentin and is currently approved for the treatment of restless leg syndrome (RLS) and postherpetic neuralgia.
For more information visit NIH.gov.