Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 168
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).
- 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
- pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
- baclofen use at baseline
- hospital discharge anticipated in within 48 hours
- ...
- pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
- baclofen use at baseline
- hospital discharge anticipated in within 48 hours
- other active drug dependence (except tobacco)
- baclofen sensitivity
- taking a medication known to interact with baclofen.
- admitted for AWS or with SEWS score >7 at baseline
- Unable to take oral medications
- Unable to provide informed consent
- no alcohol intake for ≥ 48 hours
Summary
- Conditions
- Alcohol Withdrawal Syndrome
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
See Brief Summary. Patients will recieve standard of Care treatment and monitoring for ETOH withdrawl per our insitution wide SEWS protocol. They will then be randomized to recieve baclofen 10mg tid vs placebo tid for the course of their hospital stay or 7 days, whichever comes first.
See Brief Summary. Patients will recieve standard of Care treatment and monitoring for ETOH withdrawl per our insitution wide SEWS protocol. They will then be randomized to recieve baclofen 10mg tid vs placebo tid for the course of their hospital stay or 7 days, whichever comes first.
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).
- 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
- pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
- baclofen use at baseline
- hospital discharge anticipated in within 48 hours
- ...
- pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
- baclofen use at baseline
- hospital discharge anticipated in within 48 hours
- other active drug dependence (except tobacco)
- baclofen sensitivity
- taking a medication known to interact with baclofen.
- admitted for AWS or with SEWS score >7 at baseline
- Unable to take oral medications
- Unable to provide informed consent
- no alcohol intake for ≥ 48 hours
Tracking Information
- NCT #
- NCT02052440
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Daniel B Heppe, MD Denver Health
- Daniel B Heppe, MD Denver Health
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