Preventing Alcohol Withdrawal With Oral Baclofen

Alcoholism Clinical Trial

— BACLOFEN III  

Official title:

Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01937364
• Other study ID #: EIRH-13-1134
• Status: Terminated
• Phase: Phase 2
• First received: September 4, 2013
• Last updated: March 23, 2016
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals

• Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

• Unable to provide informed consent

• Unable to take swallow oral medications (tube-fed patients are to be excluded)

• Admitted for AWS or with CIWA-Ar score >8 at baseline

• No alcohol intake for = 48 hours or AUDIT score <12 at baseline

• Baclofen use at baseline

• Baclofen sensitivity

• Hospital discharge anticipated in within 48 hours

• Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)

• Other active drug dependence (except tobacco)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Withdrawal
• Alcoholism

Intervention

Drug:
• Baclofen
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Locations

Country	Name	City	State
United States	St. Mary's Medical Center	Duluth	Minnesota
United States	Essentia Health Innovis Hospital	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol withdrawal severity as measured on CIWA-AR (Clinical Institute for Withdrawal Assessment) scale		72 hours	Yes
Secondary	Total benzodiazepine dose required		72 hours	Yes