Columbia University researchers testing opioid use disorder vaccine
The vaccine is designed to produce antibodies to oxycodone, blocking the drugs’ ability to reach the brain
The Charlotte Observer
NEW YORK — Thousands of people die each year because of an opioid-related overdose, and the coronavirus pandemic only fueled that fire, contributing to a record level of deaths in 2020.
Medications exist that can help treat opioid use disorders, but about half of those who take them end up relapsing after about six months. Now, researchers at Columbia University in New York are developing a vaccine they hope could prevent opioid overdose deaths by blocking the drugs’ ability to reach the brain.
The team is enrolling up to 24 volunteers who are active opioid users but are not taking medications to treat their disorder in an early clinical trial designed to determine if the vaccine is “well tolerated and safe.” Researchers will also study whether the shot triggers the production of sufficient antibodies that could prevent the drug from seeping into the brain.
If the vaccine proves safe, then the team will add another 21 participants. It’s the first experimental vaccine designed for the treatment of opioid use disorder to be tested in the U.S.
“A vaccine that lasts for several months, given in combination with any of [the existing] medications, could help many more people beat their addiction and potentially protect them from an overdose death if a patient relapses,” Sandra Comer, principal investigator of the clinical trial and a professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons, said in a news release.
How is the vaccine designed to work?
The vaccine is designed to produce antibodies to oxycodone, a commonly abused prescription opioid normally used to treat moderate to severe pain.
If a vaccinated person were to relapse, the antibodies their body generated would attach to the drug and block it from reaching the brain. This means the person would not feel the typical euphoric high felt after taking opioids.
The same blockage could also prevent overdose deaths, researchers say. When oxycodone reaches the brain, it can cause “respiratory depression,” a disorder in which breathing becomes slow and ineffective. The vaccine would ideally stop this process from happening.
The vaccine cannot interfere with other medications used to treat opioid use disorder because it’s designed to specifically target oxycodone. Researchers are working on developing similar vaccines that target other opioids with unique chemical makeups, such as heroin and fentanyl.
The shot also cannot interfere with naloxone, a drug used to revive consciousness in people who have overdosed.
How will the clinical trial work?
So far, preclinical studies in animals given oxycodone show the vaccine protects against “toxicity and signs of overdose, such as respiratory depression.” It also reduced the animals’ desire to consume the drug on their own.
Clinical trials will involve people who are ongoing opioid users not receiving other treatments for their use disorder. Researchers will administer non-lethal doses of oxycodone to volunteers housed in an inpatient center after they receive the vaccine and monitor their responses to the drug for several weeks. The team will then analyze volunteers’ drug use behavior “on an outpatient basis.”
One group of participants will receive a placebo shot and two other groups will get a low or high dose of the vaccine.
Meanwhile, researchers at the University of Minnesota will monitor blood samples from clinical trial volunteers “to better understand how the vaccine works.”
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