Higher Dosage of Cocaine Vaccine Is Being Tested By Researchers at Yale
Yale researchers are enrolling five cocaine addicts in a clinical trial in New Haven as part of an ongoing investigative effort to determine the safety and efficacy of the cocaine vaccine, TA-CD.
If all goes well, a second group of five to six cocaine addicts will be enrolled in the Phase Two trial in three months and will be administered a higher dose of the vaccine, again to test its safety and efficacy.
“The patients have to be followed carefully for any medical abnormalities,” said Thomas Kosten, M.D., professor of psychiatry at Yale School of Medicine and principal investigator of the study funded by the National Institute on Drug Abuse. “We are now still working with the old dose, but, assuming this turns out well with the five subjects, we will escalate to a higher dose of the vaccine and potentially look at a booster dose.”
Kosten said he hoped that within six months the research team could begin a large scale, randomized clinical trial of the vaccine. The 120 cocaine and opiate addicts in that larger study will be maintained on methadone to help insure they remain in the trial.
The vaccine alerts the immune system to the presence of cocaine in the blood, thereby stimulating antibodies that prevent the cocaine molecule from penetrating the blood brain barrier and preventing the addict from experiencing the sought after euphoric effect. The “high” that addicts experience when they relapse reinforces their addiction.
The vaccine is being developed by Xenova, a biotechnology firm in Great Britain. The company estimates that each year more than a million Americans seek treatment for cocaine addiction.