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.
Alcohol use is ubiquitous in American society. 83% of Americans have ever consumed alcohol,
51% have in the lst month.
The average American consumes 2.18 gallons of ethanol yearly. Alcohol related morbidity and
mortality are staggering problems in the USA. Symptoms of alcohol withdrawal occur because
alcohol is a central nervous system depressant; abrupt withdrawal unmasks compensatory
overactivity of certain parts of the nervous system, including sympathetic autonomic
outflow. 5% of patients who undergo alcohol suffer from Delirium Tremors (DTs), a syndrome
characterized by hallucinations, disorientation, tachycardia, hypertension, low grade fever,
agitation, and diaphoresis.
DTs typically begin between 48-96 hours after the last drink and last 1 to 5 days. DTs
requires hospitalization and vigorous activity in an ICU setting.
The most successful drug treatment for alcohol withdrawal has been found to be the
Symptom triggered treatment was found to be as effective as a fixed dose treatment to result
in less drug being used overall, with a trend toward shorter duration of withdrawal
Baclofen is used orally for the treatment of spasticity resulting from multiple sclerosis,
spinal cord injuries/diseases and intrathecally for spasticity related to cerebral palsy,
spinal cord injury, and amyotrophic lateral sclerosis (ALS).
Its proposed benefit in alcohol withdrawal is that it may reduce voluntary alcohol intake,
alcohol craving, and may suppress the intensity of alcohol withdrawal treatment.
- 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.
- 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.