Data Access Policy, Application and Agreement

A Multisite Double-Blind, Placebo-Controlled Trial of Levetiracetam Extended-Release in Very Heavy-Drinking Alcohol-Dependent Patients

Introduction

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of levetiracetam, recruiting 130 alcohol-dependent patients, 24% women and 35% ethnic minorities, from 5 sites. All subjects received either levetiracetam or placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET)  intervention. Patients were stratified on  clinical site, and  SSRI use.   No significant differences were detected between the levetiracetam XR and placebo groups in either the primary outcomes (percent heavy drinking days and percent subjects with no heavy drinking days) or in other secondary drinking outcomes. Treatment groups did not differ on a number of nondrinking outcomes, including depression, anxiety, mood, and quality of life. The only difference observed was in alcohol-related consequences. The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p=0.02). Levetiracetam XR was well-tolerated, with fatigue being the only significantly elevated adverse event, compared with placebo (53% vs. 24%, respectively; p=0.001). Results of the study is published in Alcoholism: Clinical and Experimental Research 36:1421-1430, 1421-1430, 2012.

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. 

Data Access Application Procedure and Access Policy

Because the Levetiracetam 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 this document.

Qualified researchers should complete (1) the attached Data Access Application form and (2) sign the attached Data Access 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.
Associate Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2041
Bethesda, Maryland 20892-9304
(Rockville, Maryland 20852-1705 for Federal Express)
Tel: (301) 443-0636
Fax: (301) 443-8774
Email: rlitten@mail.nih.gov

 

Data Access Application form  |  Data Access Agreement