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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Vision blurred

Distubance in attention

Sinusitis

Depression

Deep vein thrombosis

Peripheral arterial occlusive disease

Concussion

Chronic obstructive pulmonary disease

Nephrolithiasis

Pneumonia

Road traffic accident

Dehydration

100%

80%

60%

40%

20%

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

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