Preventing Alcohol Withdrawal With Oral Baclofen

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Essentia Health
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals

• Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

• Unable to provide informed consent

• Unable to take swallow oral medications (tube-fed patients are to be excluded)

• Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score >8 at baseline

• No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline

• Baclofen use at baseline

• Baclofen sensitivity

• Hospital discharge anticipated in within 48 hours

• Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)

• Other active drug dependence (except tobacco)