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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00011297
  Purpose

This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.


Condition Intervention Phase
Alcoholism
Drug: gabapentin (Neurontin)
Drug: lorazepam (Ativan)
Phase II

MedlinePlus related topics:   Alcoholism   

Drug Information available for:   Gabapentin    Lorazepam    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:   Alcohol Research Center - Treatment and Implications

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:   160
Estimated Study Completion Date:   December 2005

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
  • Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
  • Have a clinical withdrawal assessment prior to study.
  • Must be medically acceptable for study treatment. Considerations include no past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
  • Able to read, write, and speak English.
  • Have a negative urine drug screen for benzodiazepines or other sedative hypnotics, opiates, and stimulates prior to entering the study.

Exclusion Criteria:

  • Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
  • Use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
  • History of alcohol withdrawal seizures, epilepsy or delirium tremens.
  • Diagnosis of schizophrenia, bipolar disorder or dementia.
  • Liver function tests higher than normal.
  • History of hepatic encephalopathy, jaundice, ascites, diabetes, or renal disease.
  • Females who are pregnant or nursing.
  • Subjects with known sensitivity of previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines.
  • History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
  • Unable to provide an informed consent.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011297

Locations
United States, South Carolina
Medical University of South Carolina    
      Charleston, South Carolina, United States, 29425

Sponsors and Collaborators
  More Information


Study ID Numbers:   NIAAAMAL1076106
First Received:   February 15, 2001
Last Updated:   October 20, 2006
ClinicalTrials.gov Identifier:   NCT00011297
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Excitatory Amino Acids
Lorazepam
Gabapentin
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Autonomic Agents
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 20, 2008




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