Cocaine is used by more than 2 million people in the United States, according to government figures.
But a vaccine that’s aimed at blunting the drug’s “high” is about to be tested on humans. Researchers hope that if there’s no high…there won’t be any desire to use the drug.
The vaccine is being developed at NewYork-Presbyterian/Weill Cornell Medical Center, where Dr. Ronald Crystal says “Cocaine addiction is a huge problem….While there are drugs like methadone designed to treat heroin, there aren’t any therapeutics available to treat cocaine addiction. We hope that our vaccine will change that.”
Researchers on Dr. Crystal’s team have demonstrated that their vaccine has prevented cocaine from reaching the brain in earlier animal studies. Now they’re enrolling active addicts to study to test how their experimental vaccine works in people.
Vaccine gobbles cocaine
The vaccine, with the research name of dAd5GNE, is designed to absorb cocaine in the bloodstream — well before it has had a chance to pass the blood-brain barrier and then produce a dopamine-induced high. The vaccine links a cocaine-like molecule called GNE with an inactive virus that causes cold-like symptoms. The researchers expect that combination to produce an immune response. Once that happens the body sees cocaine as an enemy to be attacked. If someone who has been vaccinated uses cocaine the body responds, within seconds, with a flood of anti-cocaine antibodies. Dr. Crystal says those antibodies will then “gobble up cocaine like a Pac-man.”
“The goal of this vaccine is to prevent cocaine from reaching the brain,” Dr. Crystal says. “While we know that this works very well in animals, now we need to find out if the vaccine will cause enough anti-cocaine antibodies to be produced so that it works in humans, too.”
Addicts will be studied
Investigators hope to enroll 30 active cocaine users in the study. Before getting the vaccine, each participant will have to give up cocaine for at least 30 days, during which time they’ll undergo frequent urine screens to test for drug use. Their first vaccine dose is administered as an injection in the shoulder. Additional boosters will be given every four weeks until the participant has received six total injections. After the final booster is given in week 20, subjects will undergo monitoring for another three months, until the study’s conclusion after 32 weeks.
Each participant will have to meet with investigators two or three times per week to assess safety and efficacy. These meetings will include regular urine drug screens, EKGs, complete blood counts, and other measures of safety, as well as the review of any anti-cocaine antibodies in the participants’ systems, self-reports on cocaine cravings and subjects’ desire for other drugs and alcohol. Every subject will undergo standard drug dependency therapy throughout the study. The entire Phase I clinical study is expected to take about three years.
“Most people who become cocaine addicts want to give it up, but struggle to kick the habit in the long-term,” Dr. Crystal says. “If this vaccine works, it could represent a lifetime therapeutic for addicts.”
To enroll in the study or for more information, contact Aileen Orphilla at 646-962-2672 or email: firstname.lastname@example.org.