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Terminated
NCT03235531
Assessment of Valproate on Ethanol Withdrawal
Conditions: Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma, Heavy Drinking, Alcohol Use Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 3
Sponsor: CAMC Health System
Location: Charleston Area Medical Center, General Hospital, Level 1 Trauma Center Charleston West Virginia
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Admission to Trauma Services
* Heavy drinkers based on social history
* Men \ 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 \
Source: ClinicalTrials.gov (NCT03235531). StuddyBuddy aggregates publicly available trial information.