Treating Alcohol Withdrawal With Oral Baclofen
Information source: St. Mary's Duluth Clinic Health System
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Withdrawal Delirium
Intervention: Baclofen (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: St. Mary's Duluth Clinic Health System Official(s) and/or principal investigator(s):
Jeffrey Lyon, MD, Principal Investigator, Affiliation: St. Mary's Duluth Clinic Health System
Summary
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.
Clinical Details
Official title: Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: " 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SMDC, Duluth, Minnesota 55805, United States
Additional Information
Related 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.
Starting date: April 2003
Ending date: February 2008
Last updated: February 28, 2008
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