If the vaccine makes it through regulatory hurdles, it would be the first medication approved to treat cocaine addiction.
“It certainly is a way of combining immunology that had not been used before,” Tom Kosten, a professor of psychiatry and neuroscience at Baylor, said in a telephone interview yesterday. “We had always thought of altering the brain as a way to prevent drug abuse. This way, the drug never gets into the brain to begin with.”
Drug addiction treatment has largely been psychiatric counselling and 12-step programs. Dr. Kosten said that won't go away – any approved vaccine would be complementary to behavioural therapy.
“If it's approved in the U.S., then getting approval in Canada won't be that difficult,” he said, adding that, if all goes well, a cocaine vaccine could be available in the United States in four years.
About 50 pharmaceutical options have previously been explored for cocaine addiction.
Dr. Kosten, who has been assisted in his decade-long research by his spouse, Therese Kosten, also a psychologist and neuroscientist at Baylor, asked the U.S. Food and Drug Administration last month to allow a Phase 3 clinical trial to begin this spring, involving 300 patients at six U.S. sites. Other trials are expected in Spain and Italy.
“Because there are no treatments for cocaine addiction, it's been one of their fast-tracked programs at the FDA,” Dr. Kosten said. He is also at work on vaccines for heroin, nicotine and methamphetamine.
-Scientists testing vaccine for cocaine users