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Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

NCT02900352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-10-13

Study results available
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Summary

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.

Conditions

Interventions

DRUG

Zonisamide

Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • VA Connecticut Healthcare System

    collaborator FED

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Albert Arias, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-04-22
Completion
2021-04-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900352 on ClinicalTrials.gov