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.
"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."
In a recent study supported by NIAAA, researchers at The Scripps Research Institute in La Jolla, California, found that alcohol dependent patients using gabapentin were more likely than those taking placebo to stop drinking or refrain from heavy drinking. Gabapentin is already widely prescribed to treat pain conditions and epilepsy.
Scientists at XenoPort designed gabapentin enacarbil extended-release tablets to address certain limitations of drug levels in the body, which may make it a more attractive treatment option for people with AUD.
The planned study will be a randomized, double-blind, placebo-controlled clinical trial, meaning that participants will receive either the study drug or placebo. Neither participants nor researchers will know who received the study drug until after the trial is completed.
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.
Currently, three medications are approved by the FDA for treating alcohol dependence: disulfram, an older drug that blocks the metabolism of alcohol and causes nausea; acamprosate, which helps support abstinence and can ease symptoms of withdrawal; and naltrexone, which can help people reduce heavy drinking.