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Could a common seizure drug plus a supplement curb alcoholism?

NCT ID NCT03120468

Disease control Sponsor: Nassima Ait-Daoud Tiouririne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase pilot study tested whether combining topiramate (a seizure medication) with N-acetyl cysteine (a supplement) is safe and tolerable for people with alcohol use disorder. Seventeen adults who were heavy drinkers and seeking treatment took either the combination or topiramate alone for 12 weeks. The study focused on side effects and drinking patterns, but it was too small to draw firm conclusions about effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topiramate and N-acetyl cysteine
What this could lead to
If it works, this could point toward a new combination treatment to help people reduce heavy drinking.
What could go wrong
This is a very early, small pilot study with only 17 participants. The main goal is safety, not effectiveness, so results may not lead to a proven treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

17 people

The number who actually took part.

Started

May 2017

Finished

Jun 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females * Ages 18 and above * Good physical health * Current DSM-V diagnosis of alcohol use disorder * Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen. * Be seeking treatment for problems with alcohol * Be able to take oral medication and be willing to adhere to the medication regimen. * Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. * Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. * Not have any unresolved legal problems that could jeopardize continuation or completion of the study. * The pregnancy test for females at screen and prior to randomization must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide. Exclusion Criteria: Please contact site for additional information

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Conditions

The condition(s) this trial relates to.

alcohol abuse Behavior, Addictive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcoholism

Contacts and locations

Locations

  • UVA Center for Leading Edge Addiction Research

    Charlottesville, Virginia, 22903, United States

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