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Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)

This study has been terminated.
(The enrollment in the study was too limited for meaningful data analysis.)
Sponsor:
Information provided by (Responsible Party):
Jeffrey E Lyon, Essentia Health
ClinicalTrials.gov Identifier:
NCT01937364
First received: September 4, 2013
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Alcoholism Alcohol Withdrawal Drug: Baclofen Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
Official Title: Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jeffrey E Lyon, Essentia Health:

Primary Outcome Measures:
  • 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:
  • 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

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

Enrollment: 17
Study Start Date: November 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Jeffrey E Lyon, MD, Essentia Health
ClinicalTrials.gov Identifier: NCT01937364     History of Changes
Other Study ID Numbers: EIRH-13-1134
Study First Received: September 4, 2013
Results First Received: November 12, 2016
Last Updated: March 27, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on June 23, 2017