Assessment of Valproate on Ethanol Withdrawal

Status unconfirmed · Phase 4

Conditions studied: Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma, Heavy Drinking, Alcohol Use Disorder

In brief

Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms that can range from anxiety and restlessness to seizures, delirium and even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these medications have proven efficacy, they can also have negative side effects which may affect recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS symptoms, thus ameliorating or preventing the need for BZD administration. This trial will study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.

Key facts

Study ID

NCT03235531

Run by

CAMC Health System

People needed

210

Starts

2017-07-11

Expected to finish

2020-01-01

Last updated by the study team

2017-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Charleston Area Medical Center, General Hospital, Level 1 Trauma Center — Charleston, West Virginia, United States (enrolling)
• Charleston Area Medical Center — Charleston, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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