Recruitment

Recruitment Status
Terminated
Estimated Enrollment
168

Inclusion Criteria

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).
Adults age 21-100 admitted to medical floors at Denver Health

Exclusion Criteria

Unable to provide informed consent
pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
no alcohol intake for ≥ 48 hours
...
Unable to provide informed consent
pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
no alcohol intake for ≥ 48 hours
other active drug dependence (except tobacco)
taking a medication known to interact with baclofen.
hospital discharge anticipated in within 48 hours
baclofen use at baseline
Unable to take oral medications
admitted for AWS or with SEWS score >7 at baseline
baclofen sensitivity

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

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).
Adults age 21-100 admitted to medical floors at Denver Health

Exclusion Criteria

Unable to provide informed consent
pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
no alcohol intake for ≥ 48 hours
...
Unable to provide informed consent
pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
no alcohol intake for ≥ 48 hours
other active drug dependence (except tobacco)
taking a medication known to interact with baclofen.
hospital discharge anticipated in within 48 hours
baclofen use at baseline
Unable to take oral medications
admitted for AWS or with SEWS score >7 at baseline
baclofen sensitivity

Locations

Denver, Colorado, 80204
Denver, Colorado, 80204

Tracking Information

NCT #
NCT02052440
Collaborators
Not Provided
Investigators
  • Principal Investigator: Daniel B Heppe, MD Denver Health
  • Daniel B Heppe, MD Denver Health