Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Alcoholism
- Sponsor
- Essentia Health
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Moderate or Severe Alcohol Withdrawal Syndrome
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Jeffrey E Lyon
MD
Essentia Health
Eligibility Criteria
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 Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (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)
Arms & Interventions
Placebo
Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
Intervention: Placebo
Baclofen
Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Intervention: Baclofen
Outcomes
Primary Outcomes
Moderate or Severe Alcohol Withdrawal Syndrome
Time Frame: 72 hours
Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
Secondary Outcomes
- Peak and Total Benzodiazepine Dose Required(72 hours)
- Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment(72 hours)