NCT00229125

Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam

Gabapentin Vs. Lorazepam in Alcohol Withdrawal

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate if the medication Gabapentin, which is not approved for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal syndrome compared to treatment with Lorazepam.

Detailed description

In the current protocol we evaluated a newer generation anticonvulsant agent, gabapentin. Gabapentin does not significantly interact with alcohol or other medications, has no abuse potential, and is excreted by the kidneys and not the liver . The primary aim of the present application was to evaluate the efficacy of gabapentin in comparison to lorazepam (as a benzodiazepine gold standard) for the acute outpatient treatment of alcohol withdrawal (AW). In addition, evaluation of the lorazepam "rebound" effects observed during the current funding period will be replicated and compared with the response to gabapentin. Also, the acoustic startle response was used to evaluate the neurobiological effects of the medications on underlying AW-related CNS excitation, both during and immediately after AW. In addition, the effect of a history of multiple detoxifications on parameters such as withdrawal symptoms, CNS excitability, relapse to alcohol use, craving for alcohol, and response to medication treatment was explored.

Conditions

• Alcohol Withdrawal Syndrome(AWS)

Interventions

Type	Name	Description
DRUG	Gabapentin
DRUG	Lorazepam

Timeline

• Start date: 2001-07-01
• Completion: 2005-09-01
• First posted: 2005-09-29
• Last updated: 2005-09-29

Locations

1 site across 1 country: United States