In 1986 Rick Doblin, one of Dr Zeff's students, founded MAPS with the goal of ushering MDMA through the formal drug-approval process of America's Food and Drug Administration (FDA) and so bringing about its rescheduling. Drug approval often takes big pharmaceutical firms a dozen years at an average cost exceeding $1 billion. But Mr Doblin, then a student, had time and enthusiasm on his side.
"Our whole approach is based on the idea that science matters at the FDA," he says. No studies had been performed on the effects of banned psychoactive drugs on humans since 1971 (though a thaw came in 1990 with a study to assess the relationship between schizophrenia and dimethyltryptamine or DMT, a potent hallucinogen that occurs naturally in the brain). Mr Doblin explains that since the FDA insists that psychedelics should be treated like any other drug, "we had to start with a Phase I safety study, where the drug is first used on humans-even though millions of people had taken MDMA by then." The study got going in 1992 at the University of California, Los Angeles.
The results were positive but by the mid-1990s, when the study was complete, MDMA had become even more controversial. It was not until 2000, when Mr Doblin met Dr Mithoefer, another of Dr Zeff's former students, that the opportunity arose to propose a Phase II study on the efficacy of MDMA in treating PTSD. Treatments began in 2004.
Dr Mithoefer's Phase II research, which used MDMA from the only legal source-a chemist at Purdue University licensed by the DEA to distribute controlled quantities from a supply synthesised in 1985-is directly descended from the first generation of LSD psychotherapy. Subjects were given MDMA while attended by Dr Mithoefer and his wife, a psychiatric nurse. They rested on a futon, listened to music and were encouraged to revisit their trauma.
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