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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00011297
First received: February 15, 2001
Last updated: October 20, 2006
Last verified: October 2006

February 15, 2001
October 20, 2006
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Complete list of historical versions of study NCT00011297 on ClinicalTrials.gov Archive Site
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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
Alcohol Research Center - Treatment and Implications

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Alcoholism
  • Drug: gabapentin (Neurontin)
  • Drug: lorazepam (Ativan)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2005
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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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011297
NIAAAMAL1076106
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP