Preventing Alcohol Withdrawal With Oral Baclofen (BACLOFEN III)

Essentia Health

Status and phase: Terminated; Phase 2

Conditions: Alcoholism; Alcohol Withdrawal

Treatments: Drug: Placebo; Drug: Baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01937364

EIRH-13-1134

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Baclofen

Active Comparator group

Description:

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

Treatment:

Drug: Baclofen