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Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

NCT03120468 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-10-27

No results posted yet for this study

Summary

This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of alcohol use disorder (AUD).

Conditions

  • Alcoholism

Interventions

DRUG

Topiramate and N-Acetyl Cysteine

Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks

DRUG

Topiramate and Placebo

Topiramate up to 200 mg/day and Placebo for 12 weeks

Sponsors & Collaborators

  • Nassima Ait-Daoud Tiouririne

    lead OTHER

Principal Investigators

  • Nassima Ait-Daoud Tiouririne, M.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03120468 on ClinicalTrials.gov