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Anti-epileptic drug

Topiramate for Alcoholism

Phase 4
Waitlist Available
Led By David W. Oslin, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to test the effectiveness of topiramate in reducing heavy drinking among African American Veterans with alcohol problems. African American Veterans are targeted because they face higher death rates from alcohol-related issues. Topiramate helps by reducing the desire to drink and making alcohol less enjoyable, potentially leading to fewer heavy drinking days and more days without drinking. Topiramate has been shown to reduce drinking and heavy drinking in individuals with alcohol dependence.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Days of Heavy Drinking

Side effects data

From 2017 Phase 4 trial • 282 Patients • NCT02191579
31%
Paraesthesia
13%
Dizziness
13%
Fatigue
13%
Cognitive Disorder
13%
Nausea
11%
Decreased appetite
8%
Vision blurred
8%
Distubance in attention
7%
Sinusitis
6%
Depression
1%
Deep vein thrombosis
1%
Peripheral arterial occlusive disease
1%
Concussion
1%
Chronic obstructive pulmonary disease
1%
Nephrolithiasis
1%
Pneumonia
1%
Road traffic accident
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate
BOTOX®

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TopiramateExperimental Treatment1 Intervention
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients. The medication was dosed orally twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.
Group II: PlaceboPlacebo Group1 Intervention
a placebo control arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topiramate
FDA approved

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,692 Total Patients Enrolled
43 Trials studying Alcoholism
6,015 Patients Enrolled for Alcoholism
David W. Oslin, MDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
6 Previous Clinical Trials
2,763 Total Patients Enrolled
3 Trials studying Alcoholism
383 Patients Enrolled for Alcoholism
~10 spots leftby Oct 2025
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