Data Access Policy, Application and Agreement

A Multisite Double-Blind, Placebo-Controlled Trial of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients

Introduction

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of quetiapine, recruiting 224 alcohol-dependent patients, 20% women and 18% ethnic minorities, from 5 sites. All subjects received either quetiapine or placebo and Medical Management behavioral intervention. Patients were stratified on gender, clinical site, and reduction in drinking prior to randomization.  No differences between the quetiapine and placebo groups were detected in the primary outcome, percentage heavy-drinking days, or other drinking outcomes. Quetiapine significantly reduced depressive symptoms and improved sleep but had no effect on other nondrinking outcomes. Results from a subgroup analysis suggest that patients who reduced their drinking prior to randomization had significantly better drinking outcomes during the maintenance phase. No significant interactions, however, were observed between reducer status and treatment group. Finally, quetiapine was generally well tolerated.  Statistically significant adverse events that were more common with quetiapine versus placebo include dizziness, dry mouth, dyspepsia, increased appetite, sedation, and somnolence.

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 the VA Maryland Health Care System, 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:  Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C, Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF, Tiouririne NA, Kampman K, Stout R, and the NCIG 001 Study Group (2012). A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. Alcohol Clin Exp Res 36(3):406-16.

Data Access Application Procedure and Access Policy

Because the Quetiapine 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