drugset / Trial / NCT03012815

Gabapentin for Alcohol Withdrawal Syndrome

NCT03012815

Phase 4 Completed 88 enrolled Mayo Clinic
RandomizedParallel-groupOpen-labelTreatment

Summary

The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be completed.

Timeline

Start
2017-02-01
Primary completion
2021-03-01
Completion
2021-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Small molecule
Comparator Lorazepam Small molecule
Comparator chlordiazepoxide Small molecule
Background Divalproex Sodium Small molecule

Indications