says Sandra Comer, Ph.D., professor of neurobiology in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons and principal investigator of the trial.
‘First experimental vaccine against opioid use disorder is being tested in a phase 1a/1b clinical trial at Columbia. Upon the successful trial, the oxycodone vaccine will be then tested in phase 2 and phase 3 trials to determine its efficacy.
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Opioid Vaccine
A common opioid analgesics called oxycodone is used to relieve moderate to severe pain. The chemical gets into the brain where it causes a euphoric feeling, or “high,”. The overuse of this drug may further impair the brain’s breathing centers and cause even death.
The experimental vaccine is designed to generate antibodies against oxycodone and further prevent the oxycodone from getting into the brain. The vaccine also may protect against death from overdose due to respiratory depression.
The clinical trial aims to enroll 45 opioid users (currently being piloted in up to 24 volunteers) who are not receiving medication treatment for opioid use disorder.
One group of trial volunteers will be given a placebo; two other groups will receive either a low or high dose of the active vaccine. The trial aims to determine the toleration and safety level of the vaccine.
Efficacy of the Experiment
Apart from this, it also strives to explore the production of sufficient antibodies and the ability to prevent euphoria when the volunteers are given oxycodone. The pharmacokinetic and immunological monitoring in blood samples from participants is also undertaken to understand how the vaccine works.
“Vaccine development has been a tremendous boone to humanity. This innovative work brings it to bear on the scourge of addiction with the hope of having a great impact”, says Jeffrey A. Lieberman, MD, the Lawrence C. Kolb Professor of Psychiatry and chair of the Department of Psychiatry department at Columbia University Vagelos College of Physicians and Surgeons.
Upon the successful trial, the oxycodone vaccine will be then tested in phase 2 and phase 3 trials to determine its efficacy.
Source: Medindia