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Muscle Relaxant

Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III Trial)

Phase 2
Waitlist Available
Led By Jeffrey E Lyon, MD
Research Sponsored by Essentia Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Alcohol Use Disorder
  • Alcoholism
  • Alcohol Withdrawal Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Moderate or Severe Alcohol Withdrawal Syndrome
Secondary study objectives
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BaclofenActive Control1 Intervention
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Group II: PlaceboPlacebo Group1 Intervention
Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.

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Who is running the clinical trial?

Essentia HealthLead Sponsor
26 Previous Clinical Trials
106,932 Total Patients Enrolled
Jeffrey E Lyon, MDPrincipal InvestigatorEssentia Health
~1 spots leftby Dec 2025
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