Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

NCT ID: NCT00011297

Last Updated: 2006-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

gabapentin (Neurontin)

Intervention Type: DRUG

lorazepam (Ativan)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

NIAAAMAL1076106

Identifier Type: -

Identifier Source: org_study_id