Phenobarbital for Severe Acute Alcohol Withdrawal Syndrome
Status:
Not yet recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Severe acute alcohol withdrawal syndrome is a potentially life-threatening condition
characterized by agitation, confusion, abnormal heart rhythms and seizures. Typically,
clinicians treat the symptoms of alcohol withdrawal with a class of medications known as
benzodiazepines (e.g., Valium). These medications have a short duration of activity and
require repeated administration, often every hour or less, to reduce the symptoms of alcohol
withdrawal. Many patients suffer complications related to inadequate treatment of alcohol
withdrawal (e.g., abnormal heart rhythms, aspiration, seizures) resulting in admission to an
intensive care unit and prolonged hospital stay, all of which increase healthcare costs.
Although alcohol withdrawal is common, especially among disadvantaged (e.g., homeless)
patients, limited funding is available to advance the care of patients suffering from alcohol
withdrawal. A safe and effective treatment for severe alcohol withdrawal would benefit
patients and our healthcare system.
Phenobarbital is an inexpensive, commonly available medication that is typically used to
treat seizures. A key advantage of phenobarbital is that its calming effect lasts for a long
period of time and it can be given as a 'one-time-dose' intravenously, so that it both
prevents and treats withdrawal symptoms and reduces the need for repeated benzodiazepines.
Through better symptom control, phenobarbital is expected to reduce the costs and
complications of alcohol withdrawal. At present, physicians rarely use phenobarbital for this
purpose, and additional research is needed for this medication to become part of routine care
in clinical practice.
The PHENOMANAL pilot trial will assess safety and whether clinicians can administer a single
dose of phenobarbital intravenously, in addition to benzodiazepines, compared to
benzodiazepines alone for treating patients with severe alcohol withdrawal. This information
will inform the design of a larger clinical trial. For patients, the PHENOMANAL trial has the
potential to revolutionize how patients suffering from severe alcohol withdrawal are treated.
For society and the healthcare system, phenobarbital is expected to reduce the complications
and costs associated with severe alcohol withdrawal.
Phase:
N/A
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto