Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

October 20, 2006 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 15, 2001

First Submitted That Met QC Criteria

February 16, 2001

First Posted (Estimate)

February 19, 2001

Study Record Updates

Last Update Posted (Estimate)

October 23, 2006

Last Update Submitted That Met QC Criteria

October 20, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAMAL1076106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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