Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Phase 3

Terminated

Conditions: Alcohol Withdrawal Syndrome

Interventions: Drug: Placebo
Drug: Baclofen

Registration Number: NCT02052440

Lead Sponsor: Denver Health and Hospital Authority

Brief Summary: Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7) has important clinical implications and requires pharmacological treatment. At present, there are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol dependency in preclinical and clinical studies. We propose to examine baclofen in the prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the number of adult inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours after enrollment. Further the investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the need for symptom-triggered benzodiazepine administration during the 72 hours of hospitalization. These hypotheses will be tested in adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently placed on the SEWS monitoring and treatment protocol. These patients will be randomized to baclofen 10mg three times daily vs placebo.

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 102

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).

Exclusion Criteria

Unable to provide informed consent
Unable to take oral medications
admitted for AWS or with SEWS score >7 at baseline
no alcohol intake for ≥ 48 hours
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)
taking a medication known to interact with baclofen.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill given three times daily	Placebo	Placebo sugar bill
Baclofen 10mg three times daily	Baclofen	Baclofen 10mg by mouth three times daily

Primary Outcome Measures

Name	Time	Method
Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).	Within 72 hours	Prevention of progression to Severe Alcohol withdrawal as assessed by Severity of Ethanol Withdrawal Score (SEWS). A score of \> 7 represents moderate alcohol withdrawal and a score \> 12 severe alcohol withdrawal. Reported below as number of patients in each group progressing to moderate or severe alcohol withdrawal as assessed by SEWS score.

Secondary Outcome Measures

Name	Time	Method
Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.	72 hours	The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below.
Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .	Over 72 hours	Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and \>12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated.
Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group	72 hours	The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm.