Data Access Policy, Application and Agreement

NIAAA Protocol NCIG 002: A Multisite Double-Blind, Placebo-Controlled Trial of Levetiracetam Extended-Release in Very Heavy-Drinking Alcohol-Dependent Patients 

Description 

This multisite clinical trial evaluated the efficacy and safety of levetiracetam XR, 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 #: 00970814 

Phase:  Phase 2 

Treatment Arms: Levetiracetam XR 2000mg daily and matching placebo 

Number of clinical sites: 5  

Number of Participants: 130 

Duration: 4 months; efficacy weeks 5-14 

Population: Adults with Alcohol Use Disorder; 34% women; 31% ethnic minorities 

Other Study Details: Double-blind, Brief Behavioral Compliance Enhancement Treatment (BBCET) intervention. 

Top-line Results: 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). 

The data set was prepared by NIAAA and FastTrack Drugs and Biologics, (the Coordinating Center) and was reviewed by CSR Incorporated.  

Publication 

Fertig JB, Ryan ML, Falk DE, Litten RZ, Mattson ME, Ransom J, Rickman WJ, Scott C, Ciraulo D, Green AI, Tiouririne NA, Johnson B, Pettinati H, Strain EC, Devine E, Brunette MF, Kampman K, A Tompkins D, Stout R; NCIG 002 Study Group. 2012. A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res 36(8):1421-30.  PMID: 22324516  

Dataset Application Procedure:  

The Levetiracetam XR 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 Levetiracetam 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 002 – Levetiracetam Data Access Application 

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

NCIG 002 data use agreement                NCIG 002 data access application