Treating Alcohol Withdrawal With Oral Baclofen - Full Text View

Sponsored by:	St. Mary's Duluth Clinic Health System
Information provided by:	St. Mary's Duluth Clinic Health System
ClinicalTrials.gov Identifier:	NCT00597701

Purpose

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 ICU admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.

Condition	Intervention
Alcohol Withdrawal Delirium	Drug: Baclofen Drug: placebo

Drug Information available for: Baclofen Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial

Further study details as provided by St. Mary's Duluth Clinic Health System:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

" 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	April 2003
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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 Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
B: Placebo Comparator Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.	Drug: placebo placebo

Detailed Description:

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 sucessful 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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet DSMR IV criteria for AWS.
Be an inpatient at St. Mary's Medical Center or Miller Dwan Medical Centerat 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597701

Locations

United States, Minnesota
SMDC
Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

St. Mary's Duluth Clinic Health System

Investigators

Principal Investigator:

Jeffrey Lyon, MD

St. Mary's Duluth Clinic Health System

More Information

Publications:

Colombo G, Agabio R, Carai MA, Lobina C, Pani M, Reali R, Addolorato G, Gessa GL. Ability of baclofen in reducing alcohol intake and withdrawal severity: I--Preclinical evidence. Alcohol Clin Exp Res. 2000 Jan;24(1):58-66.

Addolorato G, Caputo F, Capristo E, Janiri L, Bernardi M, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002 Feb 15;112(3):226-9. No abstract available.

Responsible Party:	St. Mary's Duluth Clinic Health System ( Julia pattison-Crisostomo )
Study ID Numbers:	090403
Study First Received:	January 9, 2008
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00597701
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Mary's Duluth Clinic Health System:

Alcohol withdrawal
Delirium tremors

Study placed in the following topic categories:

Alcohol-Induced Disorders
Substance Withdrawal Syndrome
Neurotoxicity Syndromes
Baclofen
Neurotoxicity syndromes
Alcohol Withdrawal Delirium
Poisoning
Disorders of Environmental Origin
Confusion
Tremor
Cognition Disorders

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Substance-Related Disorders
Neurologic Manifestations
Alcohol-Related Disorders
Dementia
Neurobehavioral Manifestations
Ethanol
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Alcohol-Induced Disorders, Nervous System
Pharmacologic Actions

Muscle Relaxants, Central
Therapeutic Uses
GABA Agonists
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009