Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism

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.

Conditions

• Alcohol Dependence

Interventions

DRUG

Zonisamide

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.

BEHAVIORAL

Take Control

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. Starting on March 23, 2020, participants will participate in a simplified Take Control treatment at home due to the COVID-19 pandemic

DRUG

Placebo (for Zonisamide)

Sugar pills manufactured to mimic Zonisamide capsules.

Sponsors & Collaborators

• Mclean Hospital

  collaborator OTHER

• University of Houston

  collaborator OTHER

• Boston University Charles River Campus

  lead OTHER

Principal Investigators

• David H Barlow, PhD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-21

Primary Completion

2022-01-04

Completion

2022-01-04

FDA Drug

Yes

Countries

• United States

Study Locations