Phase I clinical trial of anti-cocaine vaccine underway

Researchers from Weill Cornell Medicine and NewYork-Presbyterian, New York, NY, have initiated a phase I clinical trial of a new anti-cocaine vaccine—dAd5GNE—they have developed to absorb cocaine in the bloodstream before it passes the blood-brain barrier.

The vaccine was formulated to blunt the effects of cocaine. Results from earlier pre-clinical studies showed that it successfully prevented cocaine from reaching the brain. Now, researchers hope to establish its safety, proper dosing, and preliminary efficacy in a phase I randomized, controlled trial in active cocaine addicts.

"Cocaine addiction is a huge problem that affects more than 2 million people in the United States, and results in more than 500,000 annual visits to emergency rooms," said principal investigator Ronald Crystal, MD, chairman, department of genetic medicine, Weill Cornell Medicine; and pulmonologist, NewYork-Presbyterian/Weill Cornell Medical Center. "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."

For this randomized, double-blind phase I study—expected to take 3 years—Dr. Crystal and colleagues hope to enroll 30 active cocaine users who will be randomized to treatment with the vaccine or placebo. They will comprise three groups of 10 each, and once the first group has finished, the second group will begin the study, followed by the third group.

Subjects must abstain from cocaine use for at least 30 days before receiving the vaccine, which will be administered via injection into the shoulder, with boosters given every 4 weeks, until a total of 6 injections is reached. At week 20, after the final booster vaccination, subjects will be monitored for another 3 months.

In addition, all subjects will be required to meet with researchers two to three times weekly for safety and efficacy assessments that will include urine drug screening, EKGs, CBCs, self-reported cravings or desire for other drugs or alcohol. Throughout the study, subjects will be subjected to standard drug dependency therapy.

"Most people who become cocaine addicts want to give it up, but struggle to kick the habit in the long-term. If this vaccine works, it could represent a lifetime therapeutic for addicts," concluded Dr. Crystal.

Participants will receive $25 per visit—up to $2,400 for those who complete the study. To enroll in the study or for more information, please contact Aileen Orphilla at 646-962-2672 or email anticocaine@med.cornell.edu.

This study is funded by the National Institute on Drug Abuse and the National Institutes of Health.