Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

NCT02052440 | Terminated Phase 3 Results

• 1 other identifier: 13-2883
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).

  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.

  Within 72 hours

Secondary Outcomes (3)

• Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .

  Over 72 hours

• 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

• 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

Study Arms (2)

Baclofen 10mg three times daily

EXPERIMENTAL

Baclofen 10mg by mouth three times daily

Drug: Baclofen

Sugar Pill given three times daily

PLACEBO COMPARATOR

Placebo sugar bill

Drug: Placebo

Interventions

Baclofen DRUG

Treatment arm: baclofen 10mg tid

Also known as: Baclofen 10mg will be given three times daily

Baclofen 10mg three times daily

Placebo DRUG

Sugar pill by mouth three times daily

Also known as: Sugar pill

Sugar Pill given three times daily

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 21-100 admitted to medical floors at Denver Health
• Patients placed on SEWS protocol by admitting physicians (at risk for AWS).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Hospital

Denver, Colorado, 80204, United States

Location

MeSH Terms

Interventions

Baclofen; Sugars

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Carbohydrates

Limitations and Caveats

The number of patients enrolled was less than was needed based on our sample size estimation due to termination of study secondary to funding limitations. This study was performed at a single, university-affiliated public safety net hospital.

Results Point of Contact

• Title: Daniel Heppe MD
• Organization: Denver Veterans Administration Medical Center

daniel.heppe@ucdenver.edu

303 399 8020

Study Officials

• Daniel B Heppe, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: March 15, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 23, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)