Clinical trial NCT02901041: Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
Official title: Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
Conditions: Alcohol Dependence
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.
Interventions:
description: ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. A dose of 400 mg daily will be used as the target maintenance dose in this study but dosing will be modified if needed to adjust for subject tolerance of drug dosing.
name: Zonisamide
other_name: Zonegran
type: Drug
description: Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.<br/>Starting on March 23, 2020, participants will participate in a simplified Take Control treatment at home due to the COVID-19 pandemic
name: Take Control
type: Behavioral
description: Sugar pills manufactured to mimic Zonisamide capsules.
name: Placebo (for Zonisamide)
type: Drug
Study arms:
design_group_description: Zonisamide capsules (with a target maintenance dose of 400 mg daily) and a seven module computerized psychotherapy for alcohol use disorders called Take Control (9 sessions) will be administered over the course of 12 weeks, followed by a two week medication taper.
design_group_title: Zonisamide & Computerized Psychotherapy
design_group_type: Experimental
design_group_description: Placebo capsules (for zonisamide) and a seven module computerized psychotherapy for alcohol use disorders called Take Control will be administered over the course of 14 weeks.
design_group_title: Placebo & Computerized Psychotherapy
design_group_type: Active Comparator
Sponsor: Winthrop University
Collaborators: University of Houston
McLean Hospital, Inc.
Drug name mappings:
name: 唑尼沙胺
lang: CN
name: Zonisamide
lang: EN
name: ゾニサミド
lang: JP