CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Topiramate (Topamax)drug
Likely dose
Topiramate (Topamax) 50 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/NCT00329407
NCT00329407Phase 4Completed
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The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

Boston University·interventional·Posted May 24, 2006·Updated Sep 8, 2010

In Brief

A Phase 4 clinical trial evaluating Topiramate (Topamax) for Alcoholism. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects. It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals. A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2006
Enrollment StartSep 1, 2003
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.1 years ago

Interventions

Topiramate (Topamax)drug

Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM