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Treating Alcohol Withdrawal With Oral Baclofen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597701
First Posted: January 18, 2008
Last Update Posted: July 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Essentia Health
Results First Submitted: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Alcohol Withdrawal Delirium
Interventions: Drug: Baclofen
Drug: Placebo
Drug: Lorazepam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-nine subjects met study inclusion criteria, and provided informed consent for participation in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 79 enrolled subjects, 44 developed signs of Alcohol Withdrawal Syndrome (AWS) sufficient to meet Diagnostic and Statistical Manual, 4th version, revised (DSMr–IV) criteria for AWS. These 44 were randomized to receive baclofen or placebo, in addition to benzodiazepine therapy. Of the 44 subjects randomized, 31 completed 72 hours of observation.

Reporting Groups
  Description
Baclofen Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Placebo Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.

Participant Flow:   Overall Study
    Baclofen   Placebo
STARTED   25   21 
COMPLETED   18   13 
NOT COMPLETED   7   8 
Withdrawal by Subject                5                5 
Death                0                1 
Physician Decision                2                0 
Did not start intervention (pharmacy er)                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Baclofen Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Placebo Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
Total Total of all reporting groups

Baseline Measures
   Baclofen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   19   44 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   24   18   42 
>=65 years   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.5  (10.3)   46.1  (11.9)   46.9  (10.9) 
Gender 
[Units: Participants]
     
Female   6   1   7 
Male   19   18   37 
Region of Enrollment 
[Units: Participants]
     
United States   25   19   44 


  Outcome Measures

1.  Primary:   Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups   [ Time Frame: From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles E Gessert, MD, MPH
Organization: Essentia Health
phone: 218-786-8176
e-mail: cgessert@eirh.org


Publications:

Responsible Party: Jeffrey Lyon, MD, Essentia Health
ClinicalTrials.gov Identifier: NCT00597701     History of Changes
Other Study ID Numbers: 090403
First Submitted: January 9, 2008
First Posted: January 18, 2008
Results First Submitted: June 29, 2011
Results First Posted: July 26, 2011
Last Update Posted: July 27, 2011