A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol
Kenna GA et al. - 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. Methods- 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).
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