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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01937364
Other study ID # EIRH-13-1134
Secondary ID
Status Terminated
Phase Phase 2
First received September 4, 2013
Last updated March 23, 2016
Start date November 2013
Est. completion date June 2015

Study information

Verified date March 2016
Source Essentia Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States St. Mary's Medical Center Duluth Minnesota
United States Essentia Health Innovis Hospital Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol withdrawal severity as measured on CIWA-AR (Clinical Institute for Withdrawal Assessment) scale 72 hours Yes
Secondary Total benzodiazepine dose required 72 hours Yes
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