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NIAAA to conduct clinical trial of Horizant for severe alcohol use disorder

The National Institute of Alcohol Abuse and Alcoholism recently announced it is conducting a clinical trial assessing the safety and efficacy of Horizant to treat severe alcohol use disorder.

Horizant (gabapentin enacarbil, XenoPort, Inc) is currently approved for treatment of restless leg syndrome and nerve pain caused by shingles and widely prescribed to treat pain conditions and epilepsy, according to a press release from the NIH.

The NIAAA is partnering with XenoPort Inc., which will supply gabapentin enacarbil for the study.

The randomized, double-blind, placebo-controlled clinical trial will assess efficacy and safety of gabapentin enacarbil among 346 patients with alcohol use disorder across 10 sites in the United States. Study participants will receive 600 mg of gabapentin enacarbil or placebo twice daily for 26 weeks.

Researchers will evaluate if treatment reduces heavy drinking during the last month of treatment.

A recent study conducted by researchers at the Scripps Research Institute in La Jolla, California, found that patients with alcohol use disorder who received gabapentin were more likely to stop or abstain from heavy drinking compared with controls.

“This multisite, well-controlled clinical trial will allow us to evaluate the safety and effectiveness of gabapentin enacarbil in treating alcohol use disorder,” George F. Koob, PhD, director of NIAAA, said in the release. “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 [alcohol use disorder].”

For more information:

Visit https://www.clinicaltrials.gov to learn more about the clinical trial.