Preventing Alcohol Withdrawal With Oral Baclofen



Status:Terminated
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:June 2015

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

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.


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 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)
We found this trial at
2
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Fargo, North Dakota 58103
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Duluth, Minnesota 55805
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Duluth, MN
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