Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
Status:
Active, not recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000
deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however,
approved medications for the treatment of AUD has shown limited effectiveness.
Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a
placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of
action seems to be quite distinct from currently approved anti-alcoholism medications, which
holds promise for treatment of individuals who are not responsive to conventional
medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's
efficacy in treating patients with a diagnosis of AUD.
To fill in these gaps, the investigators will conduct a double-blind randomized controlled
study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol
consumption in patients with AUD. Participants will be randomized to one of two conditions:
1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2)
treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential
therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC
versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as
well as an alcohol related cues task.
Phase:
Phase 3
Details
Lead Sponsor:
Boston University Boston University Charles River Campus