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Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)

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ClinicalTrials.gov Identifier: NCT01937364
Recruitment Status : Terminated (The enrollment in the study was too limited for meaningful data analysis.)
First Posted : September 9, 2013
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey E Lyon, 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.

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Withdrawal Drug: Baclofen Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

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 Name: lioresal




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Peak and Total Benzodiazepine Dose Required [ Time Frame: 72 hours ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937364


Locations
United States, Minnesota
St. Mary's Medical Center
Duluth, Minnesota, United States, 55805
United States, North Dakota
Essentia Health Innovis Hospital
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Jeffrey E Lyon, MD Essentia Health

Responsible Party: Jeffrey E Lyon, MD, Essentia Health
ClinicalTrials.gov Identifier: NCT01937364     History of Changes
Other Study ID Numbers: EIRH-13-1134
First Posted: September 9, 2013    Key Record Dates
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders