Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Condition: Alcohol Withdrawal Syndrome
MeSH terms: Syndrome; Substance Withdrawal Syndrome
Intervention: Baclofen; Placebo
Intervention description: Treatment arm: baclofen 10mg tid; Sugar pill by mouth three times daily
Intervention MeSH terms: Baclofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Adult medical/surgical inpatient hospital care is more difficult and more expensive when
      complicated by alcohol dependency (AD), especially for patients who develop alcohol
      withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol
      Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care
      for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7)
      has important clinical implications and requires pharmacological treatment. At present, there
      are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a
      GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with
      multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol
      dependency in preclinical and clinical studies. We propose to examine baclofen in the
      prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize
      that Baclofen, as compared to placebo, will significantly reduce the number of adult
      inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours
      after enrollment. Further the investigators hypothesize that Baclofen, as compared to
      placebo, will significantly reduce the need for symptom-triggered benzodiazepine
      administration during the 72 hours of hospitalization. These hypotheses will be tested in
      adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently
      placed on the SEWS monitoring and treatment protocol. These patients will be randomized to
      baclofen 10mg three times daily vs placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 21-100 admitted to medical floors at Denver Health

          -  Patients placed on SEWS protocol by admitting physicians (at risk for AWS).

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Unable to take oral medications

          -  admitted for AWS or with SEWS score >7 at baseline

          -  no alcohol intake for ≥ 48 hours

          -  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)

          -  taking a medication known to interact with baclofen.