Trial · NCT02052440
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
NCT02052440, Phase 3, Terminated, Denver Health and Hospital Authority; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preventing Alcohol Withdrawal Syndrome With Oral Baclofen. Trials, record NCT02052440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052440
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
- NCT number
- NCT02052440
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 102 participants, actual
- Lead sponsor
- Denver Health and Hospital Authority
- Conditions
- Alcohol Withdrawal Syndrome
- Interventions
- Baclofen, Placebo
- First posted
- 2014-02-03
- Last updated
- 2018-05-23
- Results first posted
- 2018-03-27
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS). | Within 72 hours | 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. |
| Secondary | Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Over 72 hours | 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. |
| 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 | 72 hours | 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. |
| Secondary | Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group. | 72 hours | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS). | Within 72 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Over 72 hours | Unit on Scale | MEAN | |
| 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 | 72 hours | Maximum dose of symptom driven benzodiazepine | Milligram of Diazepam | MEAN |
| SECONDARY | Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group. | 72 hours | Cumulative dose of symptom driven benzodiazepine | Milligram of Diazepam | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS). | Baclofen 10mg Three Times Daily | 13 | Participants | ||
| Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS). | Sugar Pill Given Three Times Daily | 16 | Participants | ||
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Baclofen 10mg Three Times Daily | Highest SEWS score at 24 hours | 6 | Standard Deviation 4 | Unit on Scale |
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Sugar Pill Given Three Times Daily | Highest SEWS score at 24 hours | 6 | Standard Deviation 4 | Unit on Scale |
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Baclofen 10mg Three Times Daily | Highest SEWS score at 48 hours | 4 | Standard Deviation 3 | Unit on Scale |
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Sugar Pill Given Three Times Daily | Highest SEWS score at 48 hours | 4 | Standard Deviation 4 | Unit on Scale |
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Baclofen 10mg Three Times Daily | Highest SEWS score at 72 hours | 2 | Standard Deviation 3 | Unit on Scale |
| Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. . | Sugar Pill Given Three Times Daily | Highest SEWS score at 72 hours | 3 | Standard Deviation 3 | Unit on Scale |
| Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group | Baclofen 10mg Three Times Daily | 11 | Standard Deviation 2 | Milligram of Diazepam | |
| Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group | Sugar Pill Given Three Times Daily | 12 | Standard Deviation 7 | Milligram of Diazepam |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baclofen 10mg Three Times Daily | 50 | |
| Overall Study | STARTED | Sugar Pill Given Three Times Daily | 52 | |
| Overall Study | COMPLETED | Baclofen 10mg Three Times Daily | 50 | |
| Overall Study | COMPLETED | Sugar Pill Given Three Times Daily | 51 | |
| Overall Study | NOT COMPLETED | Baclofen 10mg Three Times Daily | 0 | |
| Overall Study | NOT COMPLETED | Sugar Pill Given Three Times Daily | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Baclofen 10mg Three Times Daily | 1 | 50 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Sugar Pill Given Three Times Daily | 0 | 51 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen 10mg Three Times Daily | 0 | 50 |
| Total, all-cause mortality | Sugar Pill Given Three Times Daily | 0 | 51 |
| Total, other adverse events | Baclofen 10mg Three Times Daily | 1 | 50 |
| Total, other adverse events | Sugar Pill Given Three Times Daily | 0 | 51 |
| Total, serious adverse events | Baclofen 10mg Three Times Daily | 0 | 50 |
| Total, serious adverse events | Sugar Pill Given Three Times Daily | 0 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Baclofen 10mg Three Times Daily vs Sugar Pill Given Three Times Daily: deaths from any cause | Trial comparisons |
| Baclofen 10mg Three Times Daily vs Sugar Pill Given Three Times Daily: Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS). | Trial comparisons |
| Baclofen 10mg Three Times Daily vs Sugar Pill Given Three Times Daily: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02052440
GET https://conductscience.org/api/trials/v1/NCT02052440/registered