NCT02052440

Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Preventing Alcohol Withdrawal Syndrome With Oral Baclofen: A Randomized, Placebo Controlled Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

See Brief Summary. Patients will recieve standard of Care treatment and monitoring for ETOH withdrawl per our insitution wide SEWS protocol. They will then be randomized to recieve baclofen 10mg tid vs placebo tid for the course of their hospital stay or 7 days, whichever comes first.

Conditions

• Alcohol Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	Baclofen	Treatment arm: baclofen 10mg tid
DRUG	Placebo	Sugar pill by mouth three times daily

Timeline

• Start date: 2014-03-15
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-02-03
• Last updated: 2018-05-23
• Results posted: 2018-03-27

Locations

1 site across 1 country: United States