Alcoholism Clinical Trial
— BACLOFEN IIIOfficial title:
Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
Verified date | March 2016 |
Source | Essentia Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | St. Mary's Medical Center | Duluth | Minnesota |
United States | Essentia Health Innovis Hospital | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Essentia Health |
United States,
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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