Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)

March 27, 2017 updated by: Jeffrey E Lyon, Essentia Health

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Innovis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate or Severe Alcohol Withdrawal Syndrome
Time Frame: 72 hours
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
Time Frame: 72 hours
Range: 0 to 67; larger values indicate greater severity
72 hours
Peak and Total Benzodiazepine Dose Required
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essentia Health

Investigators

  • Principal Investigator: Jeffrey E Lyon, MD, Essentia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIRH-13-1134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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