The US National Institutes of Health’s (NIH) National Institute on Alcohol Abuse and Alcoholism (NIAAA) has initiated a clinical trial of Horizant (gabapentin enacarbil) extended-release tablets to treat patients with moderate to severe alcohol use disorder (AUD).
NIAAA is working in partnership with XenoPort, a biopharmaceutical company, which will supply gabapentin enacarbil for the trial. A total of 346 patients will be enrolled in this randomised, double-blind, placebo-controlled clinical trial at ten sites across the US.
The trial is designed to evaluate the safety and efficacy of 1,200mg of Horizant, administered in two daily doses of 600mg each, compared with placebo to reduce drinking in subjects who report four or more symptoms of AUD.
In the trial, eligible patients will be given either Horizant or placebo for 26 weeks, including one-week escalation, 24-week maintenance, and one-week taper periods.
NIAAA director George Koob said: “This multi-site, well-controlled clinical trial will allow us to evaluate the safety and effectiveness of gabapentin enacarbil in treating alcohol use disorder.
“Gabapentin has shown promising results in earlier clinical trials, and the development of new medications is an important component of our commitment to broaden the range of treatment options for people with AUD.”
NIAAA said gabapentin is already widely prescribed for the treatment of pain conditions and epilepsy. Horizant contains gabapentin enacarbil, a prodrug of gabapentin that is converted to gabapentin in the body.
Currently, gabapentin enacarbil is approved in the US to treat restless leg syndrome (RLS) and nerve pain caused by shingles.
The trial’s primary objective is to compare the efficacy of Horizant with matched placebo on the primary alcohol consumption outcome, which is percentage of subjects with no heavy drinking days during the last four weeks of the treatment.
In a recent NIAAA-supported study, 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.
Image: Alcohol use disorder affects about 16.6 million adults in the US. Photo: courtesy of pigdevilphoto / FreeDigitalPhotos.net.