Alcohol WithdrawalNCT01184417
Phenobarbital for Acute Alcohol Withdrawal
A study testing 10 mg/kg IV phenobarbital in 100 ml saline in people with Alcohol Withdrawal, run by Jonathan Rosenson at 1 site in United States.
Trial summary
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Withdrawal
- What is being tested?
- 10 mg/kg IV phenobarbital in 100 ml saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need for admission to hospital for acute alcohol withdrawal
Who cannot join
- allergy to phenobarbital, lorazepam, age<18 or >65
Trial locations and contacts
1 site in 1 country.
United States1 site
Alameda County Medical Center
Oakland, California, 94608
About this study
Official title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
- Conditions
- Alcohol Withdrawal
- Being tested
- 10 mg/kg IV phenobarbital in 100 ml saline, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg/kg IV phenobarbital in 100 ml salineDrug
10 mg/kg IV phenobarbital in 100 ml saline
placeboDrug
100 m l saline
| Study group | Role | What they receive |
|---|---|---|
| Phenobarbital group | Active comparator | 10 mg/kg IV phenobarbital in 100 ml saline Receives: Drug: 10 mg/kg IV phenobarbital in 100 ml saline |
| Placebo group | Placebo comparator | 100 ml saline Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Continuous Lorazepam Infusion
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).
Measured: 1 year
Percentage of Patients Requiring ICU Admission
admission to intensive care unit
Measured: 1 year
Total Lorazepam Required Per Patient Per Admission
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
Measured: 1 year
Secondary outcomes (5)
Length of Stay
hospital LOS, per patient, in hours from admission to discharge
Measured: 1 year
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
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.
Measured: 1 year
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
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.
Measured: 1 year
Number of Study Patients With Seizure as a Measure of Safety and Tolerability
Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
Measured: 1 year
Number of Study Patients With Mortality as a Measure of Safety and Tolerability
mortality in study patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Rosenson
- Sponsor type
- University, hospital or other
- Collaborators
- Alameda County Medical Center
- Responsible party
- Sponsor-investigator, Jonathan Rosenson, Alameda County Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184417
- Sponsor's protocol ID
- AlamedaCountyMC
- Status last verified
- Mar 2012
- First submitted
- 17 Aug 2010
- Last updated
- 9 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
- ClinicalTrials.gov ID
- NCT01184417
- Acronym / sponsor ID
- AlamedaCountyMC
- Conditions
- Alcohol Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jonathan RosensonUniversity, hospital or other
- Collaborators
- Alameda County Medical Center
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 9 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenobarbital group | Active comparator | Drug: 10 mg/kg IV phenobarbital in 100 ml saline10 mg/kg IV phenobarbital in 100 ml saline |
| Placebo group | Placebo comparator | Drug: placebo100 ml saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Need for admission to hospital for acute alcohol withdrawal
Key exclusion criteria (1 listed)
- allergy to phenobarbital, lorazepam, age<18 or >65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg/kg IV phenobarbital in 100 ml saline10 mg/kg IV phenobarbital in 100 ml saline | Drug | Phenobarbital group |
| placebo100 m l saline | Drug | Placebo group |
Primary outcome
Number of Patients Requiring Continuous Lorazepam Infusion
Time frame: 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).
Percentage of Patients Requiring ICU Admission
Time frame: 1 year
admission to intensive care unit
Total Lorazepam Required Per Patient Per Admission
Time frame: 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.
5 secondary outcomes
Length of Stay
Time frame: 1 year
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
Time frame: 1 year
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
Time frame: 1 year
Number of Study Patients With Seizure as a Measure of Safety and Tolerability
Time frame: 1 year
Number of Study Patients With Mortality as a Measure of Safety and Tolerability
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 mg/kg IV phenobarbital in 100 ml saline in people with Alcohol Withdrawal, run by Jonathan Rosenson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Requiring Continuous Lorazepam Infusion (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.