Preventing Alcohol Withdrawal With Oral Baclofen

Phase 2

Terminated

• Conditions: Alcoholism; Alcohol Withdrawal
• Interventions: Drug: Baclofen; Drug: Placebo

• Registration Number: NCT01937364
• Lead Sponsor: Essentia Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-09
• Study Start: 2013-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-11-12
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Results First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baclofen	Baclofen	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Placebo	Placebo	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.

Primary Outcome Measures

Name	Time	Method
Moderate or Severe Alcohol Withdrawal Syndrome	72 hours	Moderate or severe AWS was defined as a CIWA-AR score of at least 11.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

St. Mary's Medical Center; 🇺🇸 Duluth, Minnesota, United States

Essentia Health Innovis Hospital; 🇺🇸 Fargo, North Dakota, United States