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Alcoholism | Preventing Alcohol Withdrawal With Oral Baclofen

Alcoholism research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alcoholism

Alcohol Withdrawal

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Terminated

Start Date: November 2013

Completed Date: June 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Moderate or Severe Alcohol Withdrawal Syndrome

Secondary Outcome: Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment

Study sponsors, principal investigator, and references

Principal Investigator: Jeffrey E Lyon, MD

Lead Sponsor: Essentia Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01937364

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