FDA Approves Miami Researchers’ Hallucinogen Experiment On Humans

Copyright 1993 States News Service
States News Service

August 26, 1993, Thursday

LENGTH: 629 words


HEADLINE: FDA Approves Miami Researchers’ Hallucinogen Experiment On Humans

BYLINE: By Sarah Pekkanen, States News Service


BODY: Mark L. was snorting, smoking and injecting $100 worth of cocaine and heroin every day when his best friend overdosed and died in his arms.

Trying to wean himself from the drugs without the agony of withdrawal, Mark flew to Holland for treatment with an obscure hallucinogen called ibogaine. Three days later, he no longer craved the drugs that had gripped him.

On Wednesday, a University of Miami researcher took a step toward bringing ibogaine treatment to this country when the Food and Drug Administration agreed to allow some human testing on a case-by-case basis.

“The cocaine epidemic (in Dade County) is a major financial burden to those of us in the community,” said UM researcher Dr. Deborah Mash. “So the University of Miami School of Medicine is eager to bring some new medication into our community so we can deal with the problem that faces us in our town.”

Researchers have been testing ibogaine for years on animals, and results appear to back up addicts’ claims that the drug may temporarily halt cravings for cocaine and heroin, experts claim.

Armed with those findings, researchers, including Mash, pleaded their case for government approval on Wednesday with the FDA. They sought permission to conduct the first human experimentation with ibogaine in this country.

Mash called the results a victory and said a Miami study, to be conducted by Dr. Juan Sanchez-Ramos, remained on track. The tests will likely involve nine to 12 Dade County cocaine addicts and could begin next month.

Although researchers from Johns Hopkins University in Baltimore have found high-level doses of ibogaine cause nerve damage in the brain, Mash’s studies on primates show that low levels of the drug “demonstrate no significant neurotoxicity.”

Advocates of ibogaine also dismiss the possibility that users will become dependent on the hallucinogen.

“It has no potential for abuse and it’s nonaddictive,” maintained Bob Sisko, the director of International Coalition for Addict Self-Help (ICASH), the Holland group that treated Mark and other addicts.

But many of those who have been treated with the drug slip back into old habits.

Mark described the treatment as an intense, 72-hour experience in which he “saw my whole life before me.”

But Mark used heroin less than three months after taking ibogaine. After receiving a second dose in April, he has remained largely drug-free. The 32-year-old New Yorker is entering college this fall.

FDA researchers say the drug, which is found in the root of the West African plant iboga, was used in African religious rituals as early as 1864. Some people ingested the root in order “to seek communication from ancestors,” said FDA pharmacologist BeLinda Hayes.

But after the drug gained in popularity on the streets of New York and San Francisco, the government in 1970 classified ibogaine as a Schedule I drug, a category reserved for its most tightly controlled substances.

In October, the FDA approved, for the first time, a study with the hallucinogen Ecstasy, to be conducted by Dr. Charles Grob, a University of California-Irvine researcher. That study could start next month.

Although experiments with hallucinogens were commonly performed with FDA approval and funding during the 1940s and ’50s, research was virtually banned when authorities moved to outlaw them in the late 1960s.

Some researchers blame Dr. Timothy Leary, the former Harvard Medical School doctor who gained notoriety for taking LSD and urging other to do the same, for discrediting the field.

“Psychedelic research has been suppressed for a really long time now,” Sisko said. However, “the FDA stated some time ago that they wouldn’t stop research into particular substances because it had psychoactive properties.”

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