Research Article

A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol

  1. George A. Kenna1,*,
  2. Lorenzo Leggio1,
  3. Robert M. Swift1,2

Article first published online: 23 JUN 2009

DOI: 10.1002/hup.1042

Issue

Human Psychopharmacology: Clinical and Experimental

Human Psychopharmacology: Clinical and Experimental

Volume 24, Issue 6, pages 465–472, August 2009

Additional Information

How to Cite

Kenna, G. A., Leggio, L. and Swift, R. M. (2009), A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol. Human Psychopharmacology: Clinical and Experimental, 24: 465–472. doi: 10.1002/hup.1042

Author Information

  1. 1

    Department of Psychiatry and the Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA

  2. 2

    Veterans Administration Medical Center, Providence, Rhode Island, USA

*Brown University, PO Box G-S121-5, Providence, RI 02912, USA.

Publication History

  1. Issue published online: 4 AUG 2009
  2. Article first published online: 23 JUN 2009
  3. Manuscript Accepted: 7 MAY 2009
  4. Manuscript Received: 18 MAR 2009

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Keywords:

  • aripiprazole;
  • topiramate;
  • alcohol;
  • alcohol dependence;
  • alcoholism;
  • lab studies

Abstract

Objective

There are no reports examining the safety of taking both topiramate and aripiprazole together with alcohol. The ultimate aim for this research is to determine whether this combination is safe and is superior to either drug taken alone in reducing alcohol use in alcohol dependent patients.

Method

This was an open-label trial. Thirteen heavy drinking participants not seeking treatment for alcoholism were randomized. Participants were titrated up to 300 mg of topiramate and 30 mg of aripiprazole a day over 35 days. Participants reported adverse events (AEs) daily alcohol use and participated in an alcohol challenge session (ACS).

Results

The eight participants who completed the study achieved the maximum doses of drugs. The AEs of the drugs would suggest that the AEs profile is broader but not additive. Alcohol use from the 28 days before screening to the seven days before the ACS was reduced (p = 0.08).

Conclusion

There was no evidence that AEs of aripiprazole and topiramate are additive and can, therefore, be administered safely together with a modest amount of alcohol. There was also a trend for a reduction of alcohol use by participants. This finding has implications for further investigation of this combination of drugs for alcohol dependence. Copyright © 2009 John Wiley & Sons, Ltd.

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