BACLOFEN III: Preventing Alcohol Withdrawal With Oral Baclofen

• Sponsor: Essentia Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01937364
• Collaborator: (none)
• Enrollment: 17
• Locations: 2
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism; Alcohol Withdrawal	Drug: Baclofen; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Drug: Placebo; Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Active Comparator: Baclofen Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Drug: Baclofen; Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.; Other Names: lioresal

Outcome Measures

Primary Outcome Measures

1. Moderate or Severe Alcohol Withdrawal Syndrome [72 hours]

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

Secondary Outcome Measures

1. Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment [72 hours]

   Range: 0 to 67; larger values indicate greater severity

2. Peak and Total Benzodiazepine Dose Required [72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals

• Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's Medical Center	Duluth	Minnesota	United States	55805
2	Essentia Health Innovis Hospital	Fargo	North Dakota	United States	58103

Sponsors and Collaborators

• Essentia Health

Investigators

• Principal Investigator: Jeffrey E Lyon, MD, Essentia Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey E Lyon, MD, Essentia Health
• ClinicalTrials.gov Identifier: NCT01937364
• Other Study ID Numbers: EIRH-13-1134
• First Posted: Sep 9, 2013
• Last Update Posted: May 5, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Alcoholism; Baclofen

Study Results

Participant Flow

Arm/Group Title	Placebo	Baclofen
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Period Title: Overall Study
STARTED	9	8
COMPLETED	7	7
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Placebo	Baclofen	Total
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours	Total of all reporting groups
Overall Participants	9	8	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.9 (11.37)	48.9 (11.97)	51.5 (11.58)
Sex: Female, Male (Count of Participants)
Female	2 22.2%	1 12.5%	3 17.6%
Male	7 77.8%	7 87.5%	14 82.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 22.2%	0 0%	2 11.8%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 11.1%	0 0%	1 5.9%
White	6 66.7%	8 100%	14 82.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	8 100%	17 100%
Baseline Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.4 (2.01)	3.9 (2.42)	4.2 (2.16)

Outcome Measures

1. Primary Outcome

Title	Moderate or Severe Alcohol Withdrawal Syndrome
Description	Moderate or severe AWS was defined as a CIWA-AR score of at least 11.
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

Subjects who either had AWS prior to the collection of the 72-hour CIWA-Ar score or had a CIWA-Ar score either recorded as the 72-hour CIWA-Ar score or occurring within the one-hour window for the 72-hour CIWA-Ar score are evaluable for this endpoint.

Arm/Group Title	Placebo	Baclofen
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Measure Participants	5	7
Count of Participants [Participants]	2 22.2%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0334
	Comments	One-sided p-value
	Method	z-statistic with pooled estimate
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 90%; -0.7275 to -0.0206
	Parameter Dispersion	Type: Value:
	Estimation Comments	RD = Baclofen - Placebo

2. Secondary Outcome

Title	Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment
Description	Range: 0 to 67; larger values indicate greater severity
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

All CIWA-Ar scores collected at and after the baseline measurement.

Arm/Group Title	Placebo	Baclofen
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Measure Participants	9	8
24 hours	3.1325 (0.5283)	2.4418 (0.5572)
48 hours	1.7913 (0.4666)	1.9878 (0.4430)
72 hours	0.4501 (0.5646)	1.5339 (0.4179)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments	Baclofen - Placebo; 24 hours
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3744
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments	Baclofen - Placebo; 48 hours
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7616
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments	Baclofen - Placebo; 72 hours
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1393
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Peak and Total Benzodiazepine Dose Required
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Baclofen
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Measure Participants	9	8
Peak Ativan 1mg PO equivalent dose	1.0	0.5
Total Ativan 1mg PO equivalent dose	1.0	0.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments	Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baclofen
	Comments	Baclofen - Placebo; Total Ativan 1mg PO equivalent dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Placebo		Baclofen
Arm/Group Description	Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.		Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
All Cause Mortality
	Placebo		Baclofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Baclofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Baclofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.