NCT01937364

Preventing Alcohol Withdrawal With Oral Baclofen

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Essentia Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.

Conditions

• Alcoholism
• Alcohol Withdrawal

Interventions

Type	Name	Description
DRUG	Baclofen	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
DRUG	Placebo	Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-09-09
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

2 sites across 1 country: United States