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Sponsored by: |
St. Mary's Duluth Clinic Health System |
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Information provided by: | St. Mary's Duluth Clinic Health System |
ClinicalTrials.gov Identifier: | NCT00597701 |
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 |
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Alcohol Withdrawal Delirium |
Drug: Baclofen Drug: placebo |
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 |
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 |
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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.
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Drug: Baclofen
Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
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B: Placebo Comparator
Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
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Drug: placebo
placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
SMDC | |
Duluth, Minnesota, United States, 55805 |
Principal Investigator: | Jeffrey Lyon, MD | St. Mary's Duluth Clinic Health System |
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 |
Alcohol withdrawal Delirium tremors |
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 |
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 |