PMID- 19551762 OWN - NLM STAT- MEDLINE DCOM- 20091020 LR - 20220321 IS - 1099-1077 (Electronic) IS - 0885-6222 (Linking) VI - 24 IP - 6 DP - 2009 Aug TI - A safety and tolerability laboratory study of the combination of aripiprazole and topiramate in volunteers who drink alcohol. PG - 465-72 LID - 10.1002/hup.1042 [doi] AB - 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. CI - 2009 John Wiley & Sons, Ltd. FAU - Kenna, George A AU - Kenna GA AD - Department of Psychiatry and the Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA. George_Kenna@Brown.edu FAU - Leggio, Lorenzo AU - Leggio L FAU - Swift, Robert M AU - Swift RM LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Hum Psychopharmacol JT - Human psychopharmacology JID - 8702539 RN - 0 (Antipsychotic Agents) RN - 0 (Neuroprotective Agents) RN - 0 (Piperazines) RN - 0 (Quinolones) RN - 0H73WJJ391 (Topiramate) RN - 30237-26-4 (Fructose) RN - 82VFR53I78 (Aripiprazole) SB - IM MH - Adult MH - Alcohol Drinking/*adverse effects MH - Alcoholism/rehabilitation MH - Antipsychotic Agents/administration & dosage/*adverse effects MH - Aripiprazole MH - Dose-Response Relationship, Drug MH - Drug Interactions MH - Female MH - Fructose/administration & dosage/adverse effects/*analogs & derivatives MH - Humans MH - Male MH - Middle Aged MH - Neuroprotective Agents/administration & dosage/adverse effects MH - Piperazines/administration & dosage/*adverse effects MH - Quinolones/administration & dosage/*adverse effects MH - Topiramate MH - Young Adult EDAT- 2009/06/25 09:00 MHDA- 2009/10/21 06:00 CRDT- 2009/06/25 09:00 PHST- 2009/06/25 09:00 [entrez] PHST- 2009/06/25 09:00 [pubmed] PHST- 2009/10/21 06:00 [medline] AID - 10.1002/hup.1042 [doi] PST - ppublish SO - Hum Psychopharmacol. 2009 Aug;24(6):465-72. doi: 10.1002/hup.1042.