Aripiprazole and Topiramate on Free-Choice Alcohol Use
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The current study investigates the effects of two potential alcohol treatment medications on
drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin
receptors with fewer limiting side effects seen with other atypical antipsychotics.
Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise
in reducing heavy drinking. Few studies have used two medications with such a diverse
combination of actions to examine a potential synergistic effect on reducing alcohol
consumption.
The primary aims are to:
1. determine if APZ and TPMT are each more effective than placebo, and the combination of
APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol
use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol
self-administration experiment (ASAE)
2. examine a hypothesized dose-response for three doses of APZ (0, 7.5 mg/d and 15 mg/d)
along with three doses of TPMT (0, 100mg/d and 200mg/d)
3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving,
subjective stimulation, candidate gene influences and other behavioral effects
associated with alcohol consumption
4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol
dependent Participants (N=216) will be recruited from the community and randomly
assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week
titration to their target dose, leading to an in-laboratory alcohol self administration
session, during which clinical and behavioral effects are assessed during access to
alcohol. A 1 month follow-up assesses adverse events and drinking.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)