Preventing Alcohol Withdrawal With Oral Baclofen

Phase 2TerminatedNCT01937364

Essentia Health17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Alcoholism Alcohol Withdrawal

Interventions

BaclofenDRUG

Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

PlaceboDRUG

Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Locations (2)

St. Mary's Medical Center

Duluth, Minnesota, United States

Essentia Health Innovis Hospital

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

Moderate or Severe Alcohol Withdrawal Syndrome

Moderate or severe AWS was defined as a CIWA-AR score of at least 11.

Time frame: 72 hours

Secondary Outcomes

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

Time frame: 72 hours

Peak and Total Benzodiazepine Dose Required

Time frame: 72 hours

Data from ClinicalTrials.gov

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