NCT01937364

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

September 4, 2013

Results QC Date

November 12, 2016

Last Update Submit

March 27, 2017

Conditions

AlcoholismAlcohol Withdrawal

Outcome Measures

Primary Outcomes (1)

  • Moderate or Severe Alcohol Withdrawal Syndrome

    Moderate or severe AWS was defined as a CIWA-AR score of at least 11.

    72 hours

Secondary Outcomes (2)

  • Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment

    72 hours

  • Peak and Total Benzodiazepine Dose Required

    72 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.

Drug: Placebo

Baclofen

ACTIVE COMPARATOR

Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Drug: Baclofen

Interventions

BaclofenDRUG

Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Also known as: lioresal
Baclofen
PlaceboDRUG

Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
  • Patient placed on AWS watch protocol by admitting physicians.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Innovis Hospital

Fargo, North Dakota, 58103, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Jeffrey E. Lyon, M.D.
Organization
Essentia Health
jeffrey.lyon@essentiahealth.org
218-786-2802

Study Officials

  • Jeffrey E Lyon, MD

    Essentia Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 9, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 5, 2017

Results First Posted

May 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)