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Treating Alcohol Withdrawal With Oral Baclofen

Information source: Essentia Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Withdrawal Delirium

Intervention: Baclofen (Drug); Placebo (Drug); Lorazepam (Drug)

Phase: N/A

Status: Completed

Sponsored by: Essentia Health

Official(s) and/or principal investigator(s):
Jeffrey Lyon, MD, Principal Investigator, Affiliation: Essentia Health

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 intensive care unit [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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Essentia Health, 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.

Starting date: April 2003
Last updated: July 25, 2011

Page last updated: August 23, 2015

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