At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 16 enrolled

Drug / intervention

Zonisamidedrug

Likely dose

Zonisamide 100 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00406692

NCT00406692Phase 2Completed

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The Effects of Zonisamide on Alcohol Dependence

Boston University·interventional·Posted Dec 4, 2006·Updated May 11, 2010

In Brief

A Phase 2 clinical trial evaluating Zonisamide for Alcoholism. Completed, enrolled 16 participants across 1 site.

Detailed Summary

In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAlcoholism

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2006

First PostedDec 2006

Primary CompletionAug 2008

Study CompletionNov 2009

TodayJul 2026

First PostedDec 4, 2006

Enrollment StartNov 1, 2006

Primary CompletionAug 1, 2008

Study CompletionNov 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 19.6 years ago

Interventions

Zonisamidedrug

Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.