Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Adult medical/surgical inpatient hospital care is more difficult and more expensive when
complicated by alcohol dependency (AD), especially for patients who develop alcohol
withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol
Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care
for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7)
has important clinical implications and requires pharmacological treatment. At present, there
are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a
GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with
multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol
dependency in preclinical and clinical studies. We propose to examine baclofen in the
prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize
that Baclofen, as compared to placebo, will significantly reduce the number of adult
inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours
after enrollment. Further the investigators hypothesize that Baclofen, as compared to
placebo, will significantly reduce the need for symptom-triggered benzodiazepine
administration during the 72 hours of hospitalization. These hypotheses will be tested in
adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently
placed on the SEWS monitoring and treatment protocol. These patients will be randomized to
baclofen 10mg three times daily vs placebo.