NIAAA Protocol NCIG 001: A Multisite Double-Blind, Placebo-Controlled Trial of Quetiapine Fumarate XR in Very Heavy-Drinking Alcohol-Dependent Patients

Study Details

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of quetiapine, for the treatment of alcohol use disorder (AUD).  

• 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

How to Access Quetiapine Study Data

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