Back to resultsPreventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)
Primary Purpose
Alcoholism, Alcohol Withdrawal
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baclofen
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Alcoholism
Eligibility 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)
Sites / Locations
- St. Mary's Medical Center
- Essentia Health Innovis Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Baclofen
Arm Description
Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Outcomes
Primary Outcome Measures
Moderate or Severe Alcohol Withdrawal Syndrome
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
Range: 0 to 67; larger values indicate greater severity
Peak and Total Benzodiazepine Dose Required
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01937364
Brief Title
Preventing Alcohol Withdrawal With Oral Baclofen
Acronym
BACLOFEN III
Official Title
Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The enrollment in the study was too limited for meaningful data analysis.
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Essentia Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Withdrawal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
Arm Title
Baclofen
Arm Type
Active Comparator
Arm Description
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Intervention Type
Drug
Intervention Name(s)
Baclofen
Other Intervention Name(s)
lioresal
Intervention Description
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Primary Outcome Measure Information:
Title
Moderate or Severe Alcohol Withdrawal Syndrome
Description
Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment
Description
Range: 0 to 67; larger values indicate greater severity
Time Frame
72 hours
Title
Peak and Total Benzodiazepine Dose Required
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey E Lyon, MD
Organizational Affiliation
Essentia Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Essentia Health Innovis Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Preventing Alcohol Withdrawal With Oral Baclofen
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