Clinical trial NCT02052440: Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Official title: Preventing Alcohol Withdrawal Syndrome With Oral Baclofen: A Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alcohol Withdrawal Syndrome
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).
timeFrame: Within 72 hours
Secondary outcomes:
measure: Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .
timeFrame: Over 72 hours
measure: Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group
timeFrame: 72 hours
measure: Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Hospital
state: Colorado
Study officials:
affiliation: Denver Health
name: Daniel B Heppe, MD
role: PRINCIPAL_INVESTIGATOR
References: