Could a seizure drug curb alcohol withdrawal in trauma wards?

NCT ID NCT03235531

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether valproate, a medication used for epilepsy, can help prevent or ease alcohol withdrawal symptoms in heavy drinkers admitted to trauma care. Participants receive standard treatment with lorazepam (a benzodiazepine) as needed, and some also get valproate. The goal is to see if valproate reduces the amount of lorazepam needed and improves patient outcomes.

What this could mean

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

Active substance
valproate (an anti-epileptic medication) given alongside standard lorazepam treatment
What this could lead to
If valproate works, it could reduce the need for benzodiazepines in trauma patients, potentially lowering side effects and improving recovery.
What could go wrong
This is a very small early trial (3 participants), so results may not apply broadly. Valproate has its own side effects and may not effectively prevent withdrawal symptoms.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3 people

The number who actually took part.

Started

Jul 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: * Admission to Trauma Services * Heavy drinkers based on social history * Men \<65 years: \> 4 drinks per day or 14 per week * Women: \> 3 drinks per day or 7 drinks per week * All adults \>65 years: \> 3 drinks per day or 7 drinks per week * Moderate or severe alcohol use disorder based on social history and DSM-5 criteria * Moderate: Presence of 4-5 symptoms based on social history * Severe: Presence of 6 symptoms based on social history Exclusion Criteria: * Intubated patients * Glasgow Coma Score \<8 * Grade IV liver laceration or greater * Child-Pugh Class B or greater, history of cirrhosis, or cirrhosis identified by radiographic imaging upon admission * Transaminase (AST/ALT) elevation of ≥ 2x normal * Anticipated admission less than 72 hours * Levetiracetam administration for seizure prophylaxis secondary to a traumatic brain injury * Patient with VPA as home medication * Known allergy to VPA * Patients with pre-existing blood dyscrasias, i.e. thrombocytopenia (platelet count \< 50,000, etc) * Inability to obtain social history from patient, surrogate, family member or an individual deemed to be knowledgeable about the patient's social history * Pregnancy

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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

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304, United States

  • Charleston Area Medical Center, General Hospital, Level 1 Trauma Center

    Charleston, West Virginia, 25301, United States

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