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The enrollment in the study was too limited for meaningful data analysis.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. |
|
| Baclofen | Active Comparator | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moderate or Severe Alcohol Withdrawal Syndrome | Moderate or severe AWS was defined as a CIWA-AR score of at least 11. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment | Range: 0 to 67; larger values indicate greater severity | 72 hours |
| Peak and Total Benzodiazepine Dose Required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey E Lyon, MD | Essentia Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Medical Center | Duluth | Minnesota | 55805 | United States | ||
| Essentia Health Innovis Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. |
| FG001 | Baclofen | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours |
| BG001 | Baclofen | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Moderate or Severe Alcohol Withdrawal Syndrome | Moderate or severe AWS was defined as a CIWA-AR score of at least 11. | 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. | Posted | Count of Participants | Participants | 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey E. Lyon, M.D. | Essentia Health | 218-786-2802 | jeffrey.lyon@essentiahealth.org |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. |
|
| 72 hours |
| Fargo |
| North Dakota |
| 58103 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) | Range: 0 to 67; larger values indicate greater severity | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment | Range: 0 to 67; larger values indicate greater severity | All CIWA-Ar scores collected at and after the baseline measurement. | Posted | Mean | Standard Error | units on a scale | 72 hours |
|
|
|
|
| Secondary | Peak and Total Benzodiazepine Dose Required | Posted | Median | Inter-Quartile Range | Doses | 72 hours |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Baclofen | Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. | 0 | 8 | 0 | 8 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| 72 hours |
|
| 0.7616 |
| Superiority or Other |
| Baclofen - Placebo; 72 hours | Mixed Models Analysis | 0.1393 | Superiority or Other |
| 0.80 |
| Superiority or Other |