Treating Alcohol Withdrawal With Oral Baclofen

Completed · Not applicable · Has a placebo group

Conditions studied: Alcohol Withdrawal Delirium

In brief

The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit \[ICU\] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.

Key facts

Study ID

NCT00597701

Run by

Essentia Health

People needed

79

Starts

2003-04-01

Expected to finish

2008-02-01

Last updated by the study team

2011-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for alcohol withdrawal syndrome (AWS).
• Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment.
• Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy.
• Agree to abstain for alcohol for duration of study.
• Be able to provide informed consent.

You may not qualify if…

• The patient must not have any other active drug dependence in addition to alcohol.
• Be unwilling or unable to forgo alcohol for the duration of the study.
• Be using baclofen at the time of study enrollment.
• Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment.
• have known baclofen or benzodiazepine sensitivity.
• Be unable to take oral (PO) meds.
• Be unable to complete one of two consenting procedures.
• Be pregnant or breastfeeding.
• Have a serum creatine level > 2.0.
• Have a history of non alcoholic withdrawal seizures.

Where it is running

• Essentia Health — Duluth, Minnesota, United States

Full record on ClinicalTrials.gov

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