National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 4
1969-12-31
This project will provide relevant clinical information for primary care practitioners
treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo-
controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and
carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated
alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a
1-week posttreatment followup.
Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
Completed
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
1969-12-31
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.
This clinical trial is being performed under the Best Pharmaceuticals for Children Act,
signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The
purpose of this study is to make sure that lorazepam, when given to children who are very
sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well
as a drug called midazolam. Midazolam is already approved by the FDA for this use, but
lorazepam is not, even though both drugs are commonly used for sedation.
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