Data Access Policy, Application and Agreement

NIAAA Protocol NCIG 006: A Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT® (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder

Introduction

The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANT®), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD). Men and women (n = 346) who met DSM-5 criteria for at least moderate AUD were recruited across 10 U.S. clinical sites. Participants received double-blind GE-XR (600 mg twice a day) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were prespecified for the last 4 weeks of the treatment period. The GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p = 0.157). Similarly, no clinical benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related consequences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gabapentin exposure levels compared with those in other studies using a similar dose but for other indications. Overall, GE-XR at 600 mg twice a day did not reduce alcohol consumption or craving in individuals with AUD.

The study sponsor was the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA) Clinical Investigations Group (NCIG). The data set was prepared by NIAAA and FastTrack Drugs and Biologics (the trial’s Coordinating Center) and was reviewed by CSR Incorporated.

A more detailed overview of the study and main results can be found in the primary publication:

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. 2019. Gabapentin enacarbil extended-release for alcohol use disorder: a randomized, double-blind, placebo-controlled, multisite trial assessing efficacy and safety. Alcohol Clin Exp Res, 43(1):158-169. PMID: 30403402

 

Database Application Procedure

Because the HORIZANT® (Gabapentin Enacarbil) Extended-Release Study contains individual level data, it is categorized as a controlled access data set. Access will only be provided to research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the application documents below.

Qualified researchers should complete and sign the attached Data Transfer Agreement.  This agreement is designed to protect the integrity of the data set and assure client confidentiality. Note that the signature and concurrence of your authorized institutional official is also required. This is ordinarily the person who signs grant applications. Completed applications may be submitted by e-mail, fax, or mail to:

Raye Z. Litten, Ph.D.
Acting Director
Division of Medications Development
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
6700B Rockledge Drive
Room 1320
Bethesda, MD 20892-6902
(Bethesda, Maryland 20817-6902 for Federal Express)
Phone: 301-443-0636
Fax: (301) 443-8774
Email: rlitten@mail.nih.gov

 

Data Transfer Agreement

 

NIAAA Medications Development Program

 

Last reviewed: December 2019