Treating Alcohol Withdrawal With Oral Baclofen

This study has been completed.

Study NCT00597701 Information provided by Essentia Health

First Received on January 9, 2008. Last Updated on July 25, 2011 History of Changes

Results First Received: June 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Alcohol Withdrawal Delirium
Interventions:	Drug: Baclofen Drug: Placebo Drug: Lorazepam

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-nine subjects met study inclusion criteria, and provided informed consent for participation in the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 79 enrolled subjects, 44 developed signs of Alcohol Withdrawal Syndrome (AWS) sufficient to meet Diagnostic and Statistical Manual, 4th version, revised (DSMr–IV) criteria for AWS. These 44 were randomized to receive baclofen or placebo, in addition to benzodiazepine therapy. Of the 44 subjects randomized, 31 completed 72 hours of observation.

Reporting Groups

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

Participant Flow: Overall Study

	Baclofen	Placebo
STARTED	25	21
COMPLETED	18	13
NOT COMPLETED	7	8
Withdrawal by Subject	5	5
Death	0	1
Physician Decision	2	0
Did not start intervention (pharmacy er)	0	2

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Baclofen	Placebo	Total
Number of Participants [units: participants]	25	19	44
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	24	18	42
>=65 years	1	1	2
Age [units: years] Mean ± Standard Deviation	47.5 ± 10.3	46.1 ± 11.9	46.9 ± 10.9
Gender [units: participants]
Female	6	1	7
Male	19	18	37
Region of Enrollment [units: participants]
United States	25	19	44

Outcome Measures

1. Primary:

Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups [ Time Frame: From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Charles E Gessert, MD, MPH
Organization: Essentia Health
phone: 218-786-8176
e-mail: cgessert@eirh.org

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.

Responsible Party:	Jeffrey Lyon, MD, Essentia Health
ClinicalTrials.gov Identifier:	NCT00597701 History of Changes
Other Study ID Numbers:	090403
Study First Received:	January 9, 2008
Results First Received:	June 29, 2011
Last Updated:	July 25, 2011
Health Authority:	United States: Institutional Review Board