Preventing Alcohol Withdrawal With Oral Baclofen

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholism, Alcohol Withdrawal

Intervention / Treatment
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* Drug: Baclofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. | Drug: Placebo<br>* Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.<br>|
| Active Comparator: Baclofen<br>Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. | Drug: Baclofen<br>* Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.<br>* Other names: lioresal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or Severe Alcohol Withdrawal Syndrome | Moderate or severe AWS was defined as a CIWA-AR score of at least 11. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment | Range: 0 to 67; larger values indicate greater severity | 72 hours | 
| Peak and Total Benzodiazepine Dose Required |  | 72 hours |