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   

1. A completed NCIG 001 – Quetiapine Data Access Application  

2. A completed NIAAA Data Use Agreement, signed by your Authorized Institutional Official and the Principal Investigator   

NCIG 001 data use agreement                NCIG 001 data access application