Preventing Alcohol Withdrawal With Oral Baclofen

NCT ID: NCT01937364

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

Brief 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.

Conditions

Alcoholism; Alcohol Withdrawal

Study Design

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

Study Groups

Placebo

Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Baclofen

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 every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Interventions

Baclofen

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

Intervention Type: DRUG

Placebo

Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Intervention Type: DRUG

Other Intervention Names

lioresal

Eligibility Criteria

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 Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essentia Health

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey E Lyon

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey E Lyon, MD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health

Locations

St. Mary's Medical Center

Duluth, Minnesota, United States

Essentia Health Innovis Hospital

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

EIRH-13-1134

Identifier Type: -

Identifier Source: org_study_id