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| Sponsor: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| ClinicalTrials.gov Identifier: | NCT00229125 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Withdrawal Syndrome(AWS) |
Drug: Gabapentin Drug: Lorazepam |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Gabapentin Vs. Lorazepam in Alcohol Withdrawal |
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | NIAAAMAL10761-b, NIH P-50-AA010761 |
| Study First Received: | September 27, 2005 |
| Last Updated: | September 27, 2005 |
| ClinicalTrials.gov Identifier: | NCT00229125 History of Changes |
| Health Authority: | United States: Federal Government |
|
Alcohol Withdrawal Syndrome CIWA-Ar Acoustic Startle Procedure Rebound Effect |
|
Neurotransmitter Agents Substance Withdrawal Syndrome Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Gabapentin GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Antiparkinson Agents Disorders of Environmental Origin Antiemetics Excitatory Amino Acid Agents Membrane Transport Modulators Lorazepam |
Pathologic Processes Sensory System Agents Mental Disorders Syndrome Therapeutic Uses Hypnotics and Sedatives Substance-Related Disorders Analgesics Excitatory Amino Acid Antagonists Disease Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents |