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Insufficient funding to complete with low enrollment rate
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen 10mg three times daily | Experimental | Baclofen 10mg by mouth three times daily |
|
| Sugar Pill given three times daily | Placebo Comparator | Placebo sugar bill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Treatment arm: baclofen 10mg tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and >12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B Heppe, MD | Denver Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Hospital | Denver | Colorado | 80204 | United States |
No plan to share individual patient data
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Patients could be excluded if found to be pregnant prior to being assigned to study arm.
Recruitment and enrollment began March 1 2014 and terminated Jan 1 2017. Patients were enrolled after admission to general medical services at Denver Health Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baclofen 10mg Three Times Daily | Baclofen 10mg by mouth three times daily Baclofen: Treatment arm: baclofen 10mg tid |
| FG001 | Sugar Pill Given Three Times Daily | Placebo sugar bill Placebo: Sugar pill by mouth three times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baclofen 10mg Three Times Daily | Baclofen 10mg by mouth three times daily Baclofen: Treatment arm: baclofen 10mg tid |
| BG001 | Sugar Pill Given Three Times Daily | Placebo sugar bill Placebo: Sugar pill by mouth three times daily |
| 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 | 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. | Posted | Count of Participants | Participants | Within 72 hours |
|
While subject inpatient and enrolled in study until time of discharge or maximum 96 hours, whichever came first.
Study personnel checked with nursing and treatment teams daily to monitor for adverse events
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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 | Baclofen 10mg Three Times Daily | Baclofen 10mg by mouth three times daily Baclofen: Treatment arm: baclofen 10mg tid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Patient developed rash 36 hours following initiation of study medication. Study medication was discontinued and rash improved and patient discharged |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Heppe MD | Denver Veterans Administration Medical Center | 303 399 8020 | 3940 | daniel.heppe@ucdenver.edu |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Sugar pill by mouth three times daily |
|
|
| 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 | The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm. | 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. | The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below. | 72 hours |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|
| Secondary | Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and >12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated. | Posted | Mean | Standard Deviation | Unit on Scale | Over 72 hours |
|
|
|
| Secondary | Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group | The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm. | Maximum dose of symptom driven benzodiazepine | Posted | Mean | Standard Deviation | Milligram of Diazepam | 72 hours |
|
|
|
| Secondary | Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group. | The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below. | Cumulative dose of symptom driven benzodiazepine | Posted | Mean | Standard Deviation | Milligram of Diazepam | 72 hours |
|
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Sugar Pill Given Three Times Daily | Placebo sugar bill Placebo: Sugar pill by mouth three times daily | 0 | 51 | 0 | 51 | 0 | 51 |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| Highest SEWS score at 72 hours |
|