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Could a seizure drug curb alcohol cravings? new trial investigates

NCT ID NCT05134857

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether zonisamide, a drug currently used for seizures, can help adults with alcohol use disorder drink less. About 205 treatment-seeking participants will receive either zonisamide or a placebo, along with standard support. The study measures alcohol consumption through self-reports and breathalyzer tests over 14 weeks of treatment and follow-up.

What this could mean

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

Active substance
zonisamide
What this could lead to
If successful, this could provide a new medication option to help people with alcohol use disorder drink less.
What could go wrong
This is a phase 2 trial, so it is still early. The drug may not work better than placebo, and side effects like dizziness or drowsiness are possible.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

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 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Four or more standard drinks on four or more occasions in the prior 30 days. 2. Seeking AUD treatment. 3. Aged 18-65 years. 4. DSM-5 diagnosis of AUD. 5. Ability to read and speak English. 6. Ability to provide written informed consent. 7. Breath alcohol of 0.00 during informed consent. 8. Provision of at least 1 EtG-positive urine test at any time during the induction period. 9. Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and 10. Attended at least 4 of 6 visits during the induction period. Exclusion Criteria: 1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal; 2. Currently receiving any pharmacotherapy for alcohol or in the past 30 days. 3. Current DSM-5 diagnosis of severe substance use disorder other than nicotine. 4. Suicide attempt in the last 20 years. 5. History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug 6. Systemic autoimmune disease. 7. History of current seizure disorder (e.g., are they receiving medication currently for their seizures, have they ever been told by their provider that they have epilepsy, or do they have a history of recurring seizures in the last 5 years?). 8. Current clinically significant blood dyscrasia. 9. History of clinically significant renal calculi or renal failure; renal compromise (defined by an elevation of serum creatinine above our laboratory's limit of normal). 10. History of traumatic brain injury (TBI; e.g., ever been told by a provider that they had a moderate or severe TBI, lost consciousness for 30 minutes or longer or had a post-traumatic amnesia lasting a day or longer). 11. Any other current, clinically significant physical disease \[i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin, and 12. Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Washington State University

    Spokane, Washington, 99202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.