Preventing Alcohol Withdrawal With Oral Baclofen

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alcoholism, Alcohol Withdrawal

In brief

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.

Key facts

Study ID

NCT01937364

Run by

Essentia Health

People needed

17

Starts

2013-11-01

Expected to finish

2015-06-01

Last updated by the study team

2017-05-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
• Patient placed on AWS watch protocol by admitting physicians.

You may not qualify if…

• 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)

Where it is running

• St. Mary's Medical Center — Duluth, Minnesota, United States
• Essentia Health Innovis Hospital — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.