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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011297
First Posted: February 19, 2001
Last Update Posted: October 23, 2006
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.
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 Intervention Phase
Alcoholism Drug: gabapentin (Neurontin) Drug: lorazepam (Ativan) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Alcohol Research Center - Treatment and Implications

Resource links provided by NLM:


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

Estimated Enrollment: 160
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00011297


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

ClinicalTrials.gov Identifier: NCT00011297     History of Changes
Other Study ID Numbers: NIAAAMAL1076106
First Submitted: February 15, 2001
First Posted: February 19, 2001
Last Update Posted: October 23, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Gabapentin
Lorazepam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
GABA Modulators