Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

NCT ID: NCT02052440

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-15
• Study Completion Date: 2017-01-01

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.

Conditions

Alcohol Withdrawal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Baclofen 10mg three times daily

Baclofen 10mg by mouth three times daily

Group Type: EXPERIMENTAL

Baclofen

Intervention Type: DRUG

Treatment arm: baclofen 10mg tid

Sugar Pill given three times daily

Placebo sugar bill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill by mouth three times daily

Interventions

Baclofen

Treatment arm: baclofen 10mg tid

Intervention Type: DRUG

Placebo

Sugar pill by mouth three times daily

Intervention Type: DRUG

Other Intervention Names

Baclofen 10mg will be given three times daily; Sugar pill

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel B Heppe, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Locations

Denver Health Hospital

Denver, Colorado, United States

Countries

United States

Other Identifiers

13-2883

Identifier Type: -

Identifier Source: org_study_id