Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00229125|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : September 29, 2005
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Withdrawal Syndrome(AWS)||Drug: Gabapentin Drug: Lorazepam||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Gabapentin Vs. Lorazepam in Alcohol Withdrawal|
|Study Start Date :||July 2001|
|Study Completion Date :||September 2005|
- Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
- Timeline Followback (TLFB) of drinking behaviors.
- Lower startle reflex magnitudes as an index of CNS excitability or arousal.
- Lower anxiety (Zung Anxiety Scale) and depression (Beck Depression.
- Inventory) scores.
- Subjective reports of sleep quality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229125
|United States, South Carolina|
|Medical University of South Carolina - Center for Drug and Alcohol Programs|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Robert J. Malcolm, MD||Medical University of South Carolina|
|Study Director:||Carrie Randall, PhD||Medical University of South Carolina, Center for Drug and Alcohol Programs|