Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

NCT00011297 | Completed Phase 2

• 1 other identifier: NIAAAMAL1076106
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Interventions

gabapentin (Neurontin) DRUG

lorazepam (Ativan) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Gabapentin; Lorazepam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 15, 2001
• First Posted: February 19, 2001
• Study Completion: December 1, 2005
• Last Updated: October 23, 2006

Record last verified: 2006-10

Locations

US (1)