At a glance
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A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome
In Brief
A Phase 4 clinical trial evaluating Gabapentin, Benzodiazepines, and 1 other intervention for Alcohol Withdrawal Syndrome. Completed, enrolled 88 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Gabapentin administered as a taper
Benzodiazepines administered using a symptoms triggered protocol
Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)