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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gabapentin (Neurontin)
lorazepam (Ativan)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 15, 2001
Last Updated
October 20, 2006
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00011297
Brief Title
Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
Official Title
Alcohol Research Center - Treatment and Implications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gabapentin (Neurontin)
Intervention Type
Drug
Intervention Name(s)
lorazepam (Ativan)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

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