Quetiapine Study
Data Access Policy, Application and Agreement
NIAAA Protocol NCIG 001: A Multisite Double-Blind, Placebo-Controlled Trial of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients
Description
This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of quetiapine, for the treatment of alcohol use disorder (AUD).
Study Details
Sponsor: The National Institute on Alcohol Abuse and Alcoholism’s Clinical Investigations Group (NCIG)
NCT #: 00498628
Phase: Phase 2
Treatment Arms: Quetiapine 400mg daily and matching placebo
Number of clinical sites: 5
Number of Participants: 224
Duration: 3 months; efficacy weeks 3-11
Population: Adults with Alcohol Use Disorder; 20% women; 18% ethnic minorities
Other Study Details: Double-blind
Top-line Results: 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. 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 data set was prepared by NIAAA and the VA Maryland Health Care System (the Coordinating Center) and was reviewed by CSR Incorporated.
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. PMID: 21950727
Dataset Application Procedure:
The Quetiapine Study contains individual level data and is categorized as a controlled access data set. Only qualified research investigators who, along with their institutions, have certified their agreement with the expectations and terms of access detailed in the Quetiapine Data Access Application and the NIAAA Data Use Agreement will be provided access.
To apply for access, please send the following to NIAAA-DAC@mail.nih.gov
-
A completed NCIG 001 – Quetiapine Data Access Application
-
A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator