See for NIAAA Clinical Investigations Group.
A Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Levetiracetam Extended-Release in Very Heavy Drinking Alcohol-Dependent Patients
Article first published online: 10 FEB 2012
Copyright © 2012 by the Research Society on Alcoholism
Alcoholism: Clinical and Experimental Research
Volume 36, Issue 8, pages 1421–1430, August 2012
How to Cite
Fertig, J. B., Ryan, M. L., Falk, D. E., Litten, R. Z., Mattson, M. E., Ransom, J., Rickman, W. J., Scott, C., Ciraulo, D., Green, A. I., Tiouririne, N. A., Johnson, B., Pettinati, H., Strain, E. C., Devine, E., Brunette, M. F., Kampman, K., A. Tompkins, D., Stout, R. and the 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. Alcoholism: Clinical and Experimental Research, 36: 1421–1430. doi: 10.1111/j.1530-0277.2011.01716.x
- Issue published online: 1 AUG 2012
- Article first published online: 10 FEB 2012
- Manuscript Accepted: 23 NOV 2011
- Manuscript Received: 23 SEP 2011
- Alcohol Dependence;
- Medications Development;
- Alcohol Use Disorder
Despite advances in the development of medications to treat alcohol dependence, few medications have been approved by the U.S. Food and Drug Administration. The use of certain anticonvulsant medications has demonstrated potential efficacy in treating alcohol dependence. Previous research suggests that the anticonvulsant levetiracetam may be beneficial in an alcohol-dependent population of very heavy drinkers.
In this double-blind, randomized, placebo-controlled clinical trial, 130 alcohol-dependent patients who reported very heavy drinking were recruited across 5 clinical sites. Patients received either levetiracetam extended-release (XR) or placebo and a Brief Behavioral Compliance Enhancement Treatment intervention. Levetiracetam XR was titrated during the first 4 weeks to 2,000 mg/d. This target dose was maintained during weeks 5 through 14 and was tapered during weeks 15 and 16.
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).
This multisite clinical trial showed no efficacy for levetiracetam XR compared with placebo in reducing alcohol consumption in heavy drinking alcohol-dependent patients.