RELEVANCE: Alcohol Use Disorder (AUD) affects 18 million Americans, and is linked to 80,000 deaths a year, presenting a staggering $224 billion dollar economic loss to society. Yet, there are only four medications approved by the FDA to treat AUD.
DESCRIPTION: The primary objective of this study is to compare the efficacy of HORIZANT® with a placebo on individuals with AUD. The secondary objectives are to assess other treatment benefits such as reduction in alcohol consumption, reduction in cravings of alcohol, mood, sleep quality, smoking quantity and frequency, and safety.
OUTCOMES: Results of this study can be found in the following publication:
1.Falk DE, Ryan ML, Fertig JB, Devine EG, Cruz R, Brown ES, Burns H, Salloum IM, Newport DJ, Mendelson J, Galloway G, Kampman K, Brooks C, Green AI, Brunette MF, Rosenthal RN, Dunn KE, Strain EC, Ray L, Shoptaw S, Ait-Daoud Tiouririne N, Gunderson EW, Ransom J, Scott C, Leggio L, Caras S, Mason BJ, Litten RZ; National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) Study Group. Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multisite Trial Assessing Efficacy and Safety. Alcohol Clin Exp Res. 2019 Jan;43(1):158-169. Epub 2018 Dec 9. PMID: 30403402; PMCID: PMC6317996.