Trial Outcomes & Findings for Preventing Alcohol Withdrawal Syndrome With Oral Baclofen (NCT NCT02052440)
NCT ID: NCT02052440
Last Updated: 2018-05-23
Results Overview
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.
TERMINATED
PHASE3
102 participants
Within 72 hours
2018-05-23
Participant Flow
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.
Patients could be excluded if found to be pregnant prior to being assigned to study arm.
Participant milestones
| Measure |
Baclofen 10mg Three Times Daily
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Baclofen 10mg Three Times Daily
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Baseline characteristics by cohort
| Measure |
Baclofen 10mg Three Times Daily
n=50 Participants
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 Participants
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
51 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
50 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 72 hoursPrevention 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.
Outcome measures
| Measure |
Baclofen 10mg Three Times Daily
n=50 Participants
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 Participants
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Over 72 hoursSeverity 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.
Outcome measures
| Measure |
Baclofen 10mg Three Times Daily
n=50 Participants
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 Participants
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .
Highest SEWS score at 24 hours
|
6 Unit on Scale
Standard Deviation 4
|
6 Unit on Scale
Standard Deviation 4
|
|
Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .
Highest SEWS score at 48 hours
|
4 Unit on Scale
Standard Deviation 3
|
4 Unit on Scale
Standard Deviation 4
|
|
Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .
Highest SEWS score at 72 hours
|
2 Unit on Scale
Standard Deviation 3
|
3 Unit on Scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Maximum dose of symptom driven benzodiazepine
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.
Outcome measures
| Measure |
Baclofen 10mg Three Times Daily
n=50 Participants
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 Participants
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group
|
11 Milligram of Diazepam
Standard Deviation 2
|
12 Milligram of Diazepam
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Cumulative dose of symptom driven benzodiazepine
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.
Outcome measures
| Measure |
Baclofen 10mg Three Times Daily
n=50 Participants
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 Participants
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.
|
66 Milligram of Diazepam
Standard Deviation 51
|
85 Milligram of Diazepam
Standard Deviation 63
|
Adverse Events
Baclofen 10mg Three Times Daily
Sugar Pill Given Three Times Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baclofen 10mg Three Times Daily
n=50 participants at risk
Baclofen 10mg by mouth three times daily
Baclofen: Treatment arm: baclofen 10mg tid
|
Sugar Pill Given Three Times Daily
n=51 participants at risk
Placebo sugar bill
Placebo: Sugar pill by mouth three times daily
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1 • 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
|
0.00%
0/51 • 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
|
Additional Information
Daniel Heppe MD
Denver Veterans Administration Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place