UC professor develops novel approach to combat cocaine addiction

Researcher seeks FDA approval for first‐in‐human trials of anti-cocaine antibody

Andrew Norman’s unique approach to treating cocaine addiction has been met with skepticism and consternation from fellow researchers, but it’s showing promise and caught the attention of Ohio Lt. Gov. Jon Husted.

Norman, a professor of pharmacology at the University of Cincinnati, is seeking Food and Drug Administration approval to proceed with first‐in‐human trials for his approach to treat cocaine addiction. While treatments have been developed to treat other addictions including alcohol, nicotine and opioids, a treatment for cocaine addiction has eluded scientists.

“There’s been a failure to find a treatment for cocaine abuse for more than 50 years despite the fact we know everything about the pharmacology of cocaine,” said Norman, who has a doctorate in pharmacology. “Clearly there’s something we don’t understand, some knowledge gap.”

University of Cincinnati professor Andrew Norman on a stage with Ohio Lt. Gov. Jon Husted.

Andrew Norman, second from left, a professor of pharmacology at the University of Cincinnati, speaks on stage with Ohio Lt. Gov. Jon Husted, right. Norman presented his studies at PITCH X: From Lab to Market, a forum for faculty at Ohio universities to share research that is being developed for commercialization. Photo/UC Office of Innovation.

Norman suspects the knowledge gap lies in a fundamental misunderstanding of animal models of addiction and therefore cocaine addiction itself.

The widely accepted view on cocaine is that addicts take it because it’s “positively reinforcing,” or they enjoy its effects so they continue to take it.

More than 20 years of research funded by the National Institute on Drug Abuse, however, has led Norman to contend cocaine acts on parts of the brain that control stereotypical behavior, or repetition of habits.

Thus, addicts don’t continue to take cocaine because they enjoy it. Rather, cocaine induces that repetitive behavior in users.

“It’s been very hard to get our work accepted,” Norman said. “I’ve already been deemed a heretic in the field of cocaine abuse.”

Norman’s theory could help explain why attempts to treat cocaine addiction by targeting dopamine systems, which regulate pleasure, have been unsuccessful.

Taking a different approach, Norman and his team at UC and Cincinnati Children's Hospital Medical Center have developed a human-made protein that acts like a regular antibody in the immune system, called a monoclonal antibody, in an effort to treat cocaine addiction. The antibody binds to cocaine and prevents it from entering the brain.

The aim is to decrease the probability of relapse by managing the effects of the drug.
“The complex of the antibody and cocaine is too large to get across the blood-brain barrier so it can’t get into the brain,” Norman said.

In trials in animal models, the method has shown signs of success.

“We’ve had plenty of moments where it exceeded our expectations,” Norman said. “It worked better than we thought it would.”

University of Cincinnati professor Andrew Norman stands on stage with other presenters.

University of Cincinnati professor Andrew Norman, fifth from left, stands on stage with other presenters at PITCH X: From Lab to Market. A program of InnovateOhio’s I.P. Promise initiative, PITCH X allows faculty at Ohio universities to share research that is being developed for commercialization. Photo/UC Office of Innovation.

With the help of UC’s Office of Innovation, Norman has secured multiple patents for his research, and his technology is available for licensing through the office's Tech Transfer team.

Norman also has submitted an investigational new drug application to the FDA to get permission to proceed to first-in-human clinical trials that would test the antibody’s safety in humans.

While other researchers have been resistant to Norman’s methods, Ohio’s lieutenant governor Husted invited Norman to present his findings at PITCH X: From Lab to Market, a series of short talks on a virtual stage that allows faculty at Ohio universities to share research that is being developed for commercialization.

Clinical development and human trials will take several years to complete before Norman’s cocaine treatment is ready for the market.

But after years of pushback from fellow researchers, Norman could be on the verge of finding a solution to a problem that has baffled the scientific community.

“It’s frustrating,” he said of the reaction of other researchers to his ideas. “On the other hand, few investigators are taking our approach to understanding cocaine self-administration behavior, so I can take my time and get it right.”

Featured image at top: University of Cincinnati professor Andrew Norman is seeking Food and Drug Administration approval to proceed with first‐in‐human trials for his approach to treat cocaine addiction. Photo/Colleen Kelley/UC Creative Services.

Video link: https://www.youtube.com/embed/C_cM3twiugQ?rel=0

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