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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal - Article


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Gabapentin

Neurontin


Clinical Trial: Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

This study is currently recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

MedlinePlus related topics:  Alcoholism

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: 

Expected Total Enrollment:  160

Expected completion: December 2005

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information


South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Dr. Robert Malcolm  843-792-5214 

More Information

Study ID Numbers:  NIAAAMAL1076106
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  February 15, 2001
ClinicalTrials.gov Identifier:  NCT00011297
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 6, 2008



Page Updated: June 1, 2005
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