Treating Alcohol Withdrawal With Oral Baclofen

NCT00597701 | Completed Results

• 1 other identifier: 090403
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal Delirium

Keywords

Alcohol withdrawal; Delirium tremors

Outcome Measures

Primary Outcomes (1)

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

  In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.

  From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.

Study Arms (2)

Baclofen

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; Drug: Lorazepam

Placebo

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; Drug: Lorazepam

Interventions

Baclofen DRUG

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

Also known as: Lioresal

Baclofen

Placebo DRUG

Placebo

Placebo

Lorazepam 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.

Baclofen; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Related Publications (2)

• 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.

  PMID: 10656194 BACKGROUND

• 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.

  PMID: 11893350 BACKGROUND

MeSH Terms

Conditions

Alcohol Withdrawal Delirium

Interventions

Baclofen; Lorazepam

Condition Hierarchy (Ancestors)

Alcohol-Induced Disorders, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Charles E Gessert, MD, MPH
• Organization: Essentia Health

cgessert@eirh.org

218-786-8176

Study Officials

• Jeffrey Lyon, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: April 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 27, 2011
• Results First Posted: July 26, 2011

Record last verified: 2011-07

Locations

US (1)