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Cocaine Vaccine Trial Recruitment Underway

Cocaine addiction

(National Resource Directory)

8 August 2016. An early-stage clinical trial testing a vaccine designed to prevent cocaine from reaching the brain started recruiting participants in New York. The study is conducted by Weill Cornell Medicine and New York-Presbyterian, funded by National Institute of Drug Abuse, part of National Institutes of Health.

Cocaine addiction is a continuing serious public health problem with some 1.5 million cocaine users in the U.S. age 12 and over, and more than 900,000 individuals meeting the clinical definition for dependence or abuse of the drug, according to National Institute of Drug Abuse. In addition, more than 500,000 of some 1.3 million emergency room visits for drug overdoses (38%) involve cocaine, according to a 2011 report.

The vaccine, developed in the lab of internist Ronald Crystal, who chairs Weill Cornell’s genetic medicine department, aims to treat cocaine addiction by creating antibodies that counter cocaine molecules in the blood stream before they reach the brain. Code-named dAd5GNE, the vaccine has a molecule known as GNE, similar to cocaine, connected to capsid or shell proteins from engineered adenoviruses. In their normal state, these viruses are ubiquitous and may cause mild symptoms similar to the common cold, but they also induce immune reactions.

With the engineered adenovirus, the dAd5GNE vaccine invokes an immune response not only to the viral material, but also to the connected GNE molecules. In that response, immunoglobulin G antibodies that react to cocaine are released into the blood stream. If an individual uses cocaine, the cocaine molecules passing from the lungs into the blood stream are immediately attacked by the antibodies and neutralized before they reach the brain.

“While we know that this works very well in animals,” says Crystal in a Weill Cornell statement, “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.” The clinical trial is recruiting 30 current cocaine users, who will first need to avoid all cocaine use for 30 days, which clinicians will monitor through frequent urine tests.

The vaccine will be administered to participants in groups of 10 at a time, with 7 of the 10 individuals in each group receiving the test vaccine and 3 receiving a placebo. The vaccines or placebos are given in a series of 6 injections over 20 weeks. Researchers will meet with each participant 2 or 3 times a week, measuring the presence of antibodies, as well as taking heart and blood tests for the vaccine’s safety.

Individuals in the trial will also be asked to report on their cocaine cravings, as well as use of other drugs or alcohol, as part of standard drug dependency therapy throughout the time of the study, expected to take 3 years. Participants will receive $25 per visit, for up to $2,400 for those who complete the study.

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

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