Trial · NCT01184417
Phenobarbital for Acute Alcohol Withdrawal
NCT01184417, Not applicable, Completed, Jonathan Rosenson; results first posted 2012-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phenobarbital for Acute Alcohol Withdrawal. Trials, record NCT01184417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01184417
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phenobarbital for Acute Alcohol Withdrawal
- NCT number
- NCT01184417
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 102 participants, actual
- Lead sponsor
- Jonathan Rosenson
- Conditions
- Alcohol Withdrawal
- Interventions
- 10 mg/kg IV phenobarbital in 100 ml saline, placebo
- First posted
- 2010-08-19
- Last updated
- 2012-03-09
- Results first posted
- 2012-03-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Requiring Continuous Lorazepam Infusion | 1 year | All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not). |
| Primary | Percentage of Patients Requiring ICU Admission | 1 year | admission to intensive care unit |
| Primary | Total Lorazepam Required Per Patient Per Admission | 1 year | How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams. |
| Secondary | Length of Stay | 1 year | hospital LOS, per patient, in hours from admission to discharge |
| Secondary | Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | 1 year | The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation. |
| Secondary | Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability | 1 year | Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization. |
| Secondary | Number of Study Patients With Seizure as a Measure of Safety and Tolerability | 1 year | Did the study patient have a witnessed seizure during their hospitaliztion (yes/no). |
| Secondary | Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 1 year | mortality in study patients |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Requiring Continuous Lorazepam Infusion | 1 year | participants | NUMBER | |
| PRIMARY | Percentage of Patients Requiring ICU Admission | 1 year | percentage of participants | NUMBER | |
| PRIMARY | Total Lorazepam Required Per Patient Per Admission | 1 year | milligrams | MEAN | |
| SECONDARY | Length of Stay | 1 year | hours | MEDIAN | |
| SECONDARY | Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | 1 year | participants | NUMBER | |
| SECONDARY | Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Number of Study Patients With Seizure as a Measure of Safety and Tolerability | 1 year | participants | NUMBER | |
| SECONDARY | Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 1 year | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Requiring Continuous Lorazepam Infusion | Phenobarbital Group | 2 | participants | ||
| Number of Patients Requiring Continuous Lorazepam Infusion | Placebo Group | 16 | participants | ||
| Percentage of Patients Requiring ICU Admission | Phenobarbital Group | 8 | 4 to 32 | percentage of participants | |
| Percentage of Patients Requiring ICU Admission | Placebo Group | 25 | 4 to 32 | percentage of participants | |
| Total Lorazepam Required Per Patient Per Admission | Phenobarbital Group | 26 | Standard Deviation 45 | milligrams | |
| Total Lorazepam Required Per Patient Per Admission | Placebo Group | 49 | Standard Deviation 37 | milligrams | |
| Length of Stay | Phenobarbital Group | 76 | Inter-Quartile Range 54 to 114 | hours | |
| Length of Stay | Placebo Group | 118 | Inter-Quartile Range 47 to 190 | hours | |
| Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | Phenobarbital Group | 0 | participants | ||
| Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | Placebo Group | 0 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phenobarbital Group | 51 | |
| Overall Study | STARTED | Placebo Group | 51 | |
| Overall Study | COMPLETED | Phenobarbital Group | 51 | |
| Overall Study | COMPLETED | Placebo Group | 51 | |
| Overall Study | NOT COMPLETED | Phenobarbital Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenobarbital Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Phenobarbital Group | 0 | 51 |
| Total, other adverse events | Placebo Group | 0 | 51 |
| Total, serious adverse events | Phenobarbital Group | 0 | 51 |
| Total, serious adverse events | Placebo Group | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phenobarbital Group vs Placebo Group: Number of Patients Requiring Continuous Lorazepam Infusion | Trial comparisons |
| Phenobarbital Group vs Placebo Group: Number of Study Patients With Seizure as a Measure of Safety and Tolerability | Trial comparisons |
| Phenobarbital Group vs Placebo Group: Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | Trial comparisons |
| Phenobarbital Group vs Placebo Group: Number of Study Patients With Mortality as a Measure of Safety and Tolerability | Trial comparisons |
| Phenobarbital Group vs Placebo Group: 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/NCT01184417
GET https://conductscience.org/api/trials/v1/NCT01184417/registered