Treating Alcohol Withdrawal With Oral Baclofen

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. Identifier: NCT00597701
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : July 26, 2011
Last Update Posted : July 27, 2011
Information provided by:
Essentia Health

January 9, 2008
January 18, 2008
June 29, 2011
July 26, 2011
July 27, 2011
April 2003
February 2008   (Final data collection date for primary outcome measure)
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. ]
In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.
Duration of alcohol withdrawal syndrome (AWS) as defined by duration of time from admission to study, to measurement of Clinical Institute Withdrawal Assessment for Withdrqwal for Alcohol (CIWA-Ar)<5. [ Time Frame: Duration of time from admission to study, to measurement of CIWA-Ar ]
Complete list of historical versions of study NCT00597701 on Archive Site
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" Area under the curve" how much lower the CIWA-Ar scores are for the cases, compared to the controls (until the primary endpoint is reached). This endpoint will utilize the average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study. [ Time Frame: Average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study ]
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Treating Alcohol Withdrawal With Oral Baclofen
Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial
The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.

Alcohol use is ubiquitous in American society. 83% of Americans have ever consumed alcohol, 51% have in the lst month.

The average American consumes 2.18 gallons of ethanol yearly. Alcohol related morbidity and mortality are staggering problems in the USA. Symptoms of alcohol withdrawal occur because alcohol is a central nervous system depressant; abrupt withdrawal unmasks compensatory overactivity of certain parts of the nervous system, including sympathetic autonomic outflow. 5% of patients who undergo alcohol suffer from Delirium Tremors (DTs), a syndrome characterized by hallucinations, disorientation, tachycardia, hypertension, low grade fever, agitation, and diaphoresis.

DTs typically begin between 48-96 hours after the last drink and last 1 to 5 days. DTs requires hospitalization and vigorous activity in an ICU setting.

The most successful drug treatment for alcohol withdrawal has been found to be the benzodiazepines.

Symptom triggered treatment was found to be as effective as a fixed dose treatment to result in less drug being used overall, with a trend toward shorter duration of withdrawal treatment.

Baclofen is used orally for the treatment of spasticity resulting from multiple sclerosis, spinal cord injuries/diseases and intrathecally for spasticity related to cerebral palsy, spinal cord injury, and amyotrophic lateral sclerosis (ALS).

Its proposed benefit in alcohol withdrawal is that it may reduce voluntary alcohol intake, alcohol craving, and may suppress the intensity of alcohol withdrawal treatment.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Alcohol Withdrawal Delirium
  • Drug: Baclofen
    Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
    Other Name: Lioresal
  • Drug: Placebo
  • Drug: Lorazepam
    Lorazepam was provided to all subjects (both arms of the study), as indicated by clinical condition. Standard "symptom-triggered dosing" of lorazepam for alcohol withdrawal was used. That is, the size and the frequency of the dose of lorazepam was determined by the severity of the alcohol withdrawal symptoms.
  • Active Comparator: 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.
    • Drug: Baclofen
    • Drug: Lorazepam
  • Placebo Comparator: Placebo
    Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
    • Drug: Placebo
    • Drug: Lorazepam

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for alcohol withdrawal syndrome (AWS).
  • Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment.
  • Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy.
  • Agree to abstain for alcohol for duration of study.
  • Be able to provide informed consent.

Exclusion Criteria:

  • The patient must not have any other active drug dependence in addition to alcohol.
  • Be unwilling or unable to forgo alcohol for the duration of the study.
  • Be using baclofen at the time of study enrollment.
  • Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment.
  • have known baclofen or benzodiazepine sensitivity.
  • Be unable to take oral (PO) meds.
  • Be unable to complete one of two consenting procedures.
  • Be pregnant or breastfeeding.
  • Have a serum creatine level > 2.0.
  • Have a history of non alcoholic withdrawal seizures.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Jeffrey Lyon, MD, Essentia Health
Essentia Health
Not Provided
Principal Investigator: Jeffrey Lyon, MD Essentia Health
Essentia Health
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP