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Effectiveness of Zonisamide in Alcohol Dependent Veterans

NCT02368431 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-12-07

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 Veterans.

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

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Albert J Arias, MD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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
2015-03-01
Primary Completion
2018-10-01
Completion
2018-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02368431 on ClinicalTrials.gov