Treating Alcohol Withdrawal With Oral Baclofen

NCT ID: NCT00597701

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-02-29

Brief 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.

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.

Conditions

Alcohol Withdrawal Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Baclofen

Intervention Type: DRUG

Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.

Lorazepam

Intervention Type: DRUG

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.

Placebo

Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Lorazepam

Intervention Type: DRUG

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.

Interventions

Baclofen

Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lioresal

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essentia Health

OTHER

Sponsor Role: lead

Responsible Party

Essentia Health

Principal Investigators

Jeffrey Lyon, MD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health

Locations

Essentia Health

Duluth, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10656194 (View on PubMed)

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. doi: 10.1016/s0002-9343(01)01088-9. No abstract available.

Reference Type: BACKGROUND

PMID: 11893350 (View on PubMed)

Other Identifiers

090403

Identifier Type: -

Identifier Source: org_study_id