Doctor gets FDA approval to research effect of 'Ecstasy' drug on humans

November 15, 1992|By States News Service

WASHINGTON -- For the first time, the Food and Dru Administration has cleared the way for research on the ways a hallucinogenic drug known as Ecstasy affects humans.

Dr. Charles Grob, a psychiatrist at the University of California's Irvine Medical Center, this month won FDA approval for his study, expected to take place in two months. In the study, six subjects will take low-level doses of the drug and a placebo in an attempt to determine how much of the drug is needed to !B produce noticeable effects.

The drug, also known as MDMA, has been reported to increase self-confidence and self-acceptance and induce feelings of empathy and love, which could make it a useful tool for psychotherapists, some researchers say. But they also point to negative side effects.

The FDA approval represents a major breakthrough for researchers who have, with few exceptions, been denied permission to administer hallucinogens, including LSD, to human subjects since authorities moved to outlaw the drugs in the late 1960s.

Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization funding the study, said the subjects would be selected from a pool of volunteers who took Ecstasy before the FDA outlawed it in 1985.

The six participants will be subject to oral and written tests designed to measure moods, pain and cognition, Dr. Grob said. He still must win approval from the Drug Enforcement Administration and the California Research Advisory Panel, but Mr. Doblin said he did not expect either agency to oppose the study.

The drug "may have a very unique capacity to catalyze a powerful and empathogenic experience," Dr. Grob said.

But in some studies conducted overseas and in the United States before the 1985 ban on the drug, some subjects reported negative side effects, including decreased appetite and decreased desire to perform mental or physical tasks.

Although MDMA was patented in Germany in 1914, it did not become popular in the United States until the early 1980s. Reports showed that in rodents the drug caused depletion of a vital brain chemical called serotonin.

In response, in 1985 the FDA classified MDMA as a Schedule I drug, a category reserved for the government's most tightly controlled substances.

Serotonin affects mood and plays a role in other functions, including appetite and sleep regulation.

Dr. Grob argued that massive amounts of Ecstasy were responsible for depleting the serotonin in rodents. In his study, only one-half of what is considered a normal dose of Ecstasy will be given to humans. In addition, researchers say the body may replace the serotonin that Ecstasy may deplete.

Although studies on hallucinogens were frequently performed in the 1940s and 1950s with FDA approval and funding, some of the studies -- notably Army tests with LSD on unwitting soldiers -- were not well-respected by scientists.

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