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Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam

Primary Purpose

Alcohol Withdrawal Syndrome(AWS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Lorazepam
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 Alcohol Withdrawal Syndrome(AWS) focused on measuring Alcohol Withdrawal Syndrome, CIWA-Ar, Acoustic Startle Procedure, Rebound Effect

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects must be between 21-70 years of age (both genders will be recruited). Subjects must meet DSM-IV criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome. Subjects must have a mini-mental state score above 26. Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days). Subjects must have a minimum score on the Clinical Institute Withdrawal - - Assessment for Alcohol-Revised (CIWA-Ar) of 10 within 24 hours of initial assessment. Subjects 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. Subjects must exhibit vital signs within the following range: a three-minute sitting blood pressure in the range of 90-200 mmHg systolic, 60-120 mmHg diastolic and ventricular rates between 56 and 140 beats per minute. Subjects must be suitable for treatment with oral medications. Subjects must be able to read, write, and speak English. Subjects must have a negative urine drug screen for benzodiazepines or other sedative-hypnotics, opiates, and stimulants at baseline. Exclusion Criteria: Subjects with current (past month) DSM-IV diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine, caffeine, cannabis and cocaine dependence). Use of pharmacological agents within a five half-life period that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome (e.g.,tricyclic antidepressants, anticonvulsants, neuroleptics, benzodiazepines, some centrally-acting antihypertensives such as beta-blockers, alpha-adrenergic agonists, and calcium channel antagonists, wellbutrin, buspar, any sedative-hypnotics and opiates). Subjects with a history of idiopathic epilepsy. Subjects with diagnosis of schizophrenia, bipolar disorder or dementia. Subjects with liver function tests (AST or ALT) 4 times higher than normal. Serum levels will be drawn upon admission to study and study medications terminated if necessary. History of hepatic encephalopathy, jaundice, ascites, insulin dependent diabetes, or renal disease. Females who are pregnant (as determined by a pregnancy test) or nursing. Subjects with known sensitivity or 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. Subjects who decline or who are not competent to give informed consent.

Sites / Locations

  • Medical University of South Carolina - Center for Drug and Alcohol Programs

Outcomes

Primary Outcome Measures

Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
Timeline Followback (TLFB) of drinking behaviors.

Secondary Outcome Measures

Lower startle reflex magnitudes as an index of CNS excitability or arousal.
Lower anxiety (Zung Anxiety Scale) and depression (Beck Depression.
Inventory) scores.
Subjective reports of sleep quality.

Full Information

First Posted
September 27, 2005
Last Updated
September 27, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00229125
Brief Title
Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam
Official Title
Gabapentin Vs. Lorazepam in Alcohol Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to evaluate if the medication Gabapentin, which is not approved for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal syndrome compared to treatment with Lorazepam.
Detailed Description
In the current protocol we evaluated a newer generation anticonvulsant agent, gabapentin. Gabapentin does not significantly interact with alcohol or other medications, has no abuse potential, and is excreted by the kidneys and not the liver . The primary aim of the present application was to evaluate the efficacy of gabapentin in comparison to lorazepam (as a benzodiazepine gold standard) for the acute outpatient treatment of alcohol withdrawal (AW). In addition, evaluation of the lorazepam "rebound" effects observed during the current funding period will be replicated and compared with the response to gabapentin. Also, the acoustic startle response was used to evaluate the neurobiological effects of the medications on underlying AW-related CNS excitation, both during and immediately after AW. In addition, the effect of a history of multiple detoxifications on parameters such as withdrawal symptoms, CNS excitability, relapse to alcohol use, craving for alcohol, and response to medication treatment was explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal Syndrome(AWS)
Keywords
Alcohol Withdrawal Syndrome, CIWA-Ar, Acoustic Startle Procedure, Rebound Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Primary Outcome Measure Information:
Title
Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
Title
Timeline Followback (TLFB) of drinking behaviors.
Secondary Outcome Measure Information:
Title
Lower startle reflex magnitudes as an index of CNS excitability or arousal.
Title
Lower anxiety (Zung Anxiety Scale) and depression (Beck Depression.
Title
Inventory) scores.
Title
Subjective reports of sleep quality.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be between 21-70 years of age (both genders will be recruited). Subjects must meet DSM-IV criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome. Subjects must have a mini-mental state score above 26. Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days). Subjects must have a minimum score on the Clinical Institute Withdrawal - - Assessment for Alcohol-Revised (CIWA-Ar) of 10 within 24 hours of initial assessment. Subjects 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. Subjects must exhibit vital signs within the following range: a three-minute sitting blood pressure in the range of 90-200 mmHg systolic, 60-120 mmHg diastolic and ventricular rates between 56 and 140 beats per minute. Subjects must be suitable for treatment with oral medications. Subjects must be able to read, write, and speak English. Subjects must have a negative urine drug screen for benzodiazepines or other sedative-hypnotics, opiates, and stimulants at baseline. Exclusion Criteria: Subjects with current (past month) DSM-IV diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine, caffeine, cannabis and cocaine dependence). Use of pharmacological agents within a five half-life period that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome (e.g.,tricyclic antidepressants, anticonvulsants, neuroleptics, benzodiazepines, some centrally-acting antihypertensives such as beta-blockers, alpha-adrenergic agonists, and calcium channel antagonists, wellbutrin, buspar, any sedative-hypnotics and opiates). Subjects with a history of idiopathic epilepsy. Subjects with diagnosis of schizophrenia, bipolar disorder or dementia. Subjects with liver function tests (AST or ALT) 4 times higher than normal. Serum levels will be drawn upon admission to study and study medications terminated if necessary. History of hepatic encephalopathy, jaundice, ascites, insulin dependent diabetes, or renal disease. Females who are pregnant (as determined by a pregnancy test) or nursing. Subjects with known sensitivity or 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. Subjects who decline or who are not competent to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Malcolm, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carrie Randall, PhD
Organizational Affiliation
Medical University of South Carolina, Center for Drug and Alcohol Programs
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of South Carolina - Center for Drug and Alcohol Programs
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam

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