Human Trials to Begin on Ibogaine

The Associated Press

August 27, 1993, Friday, PM cycle

LANGUAGE: ENGLISH

LOAD-DATE-MDC: August 31, 1993

SECTION: Washington Dateline

LENGTH: 162 words

HEADLINE: Human Trials Should Begin on Antidote to Drug Addiction

DATELINE: WASHINGTON

BODY: The government should consider allowing human experiments on a case-by-case basis with a controversial anti-addiction drug, an advisory panel concluded.

But the experts advising the Food and Drug Administration did not give a ringing endorsement to ibogaine, a hallucinogen derived from an African plant which sponsors claim holds promise for breaking drug addiction.

At its meeting Thursday the panel was deadlocked over the safety of the drug, which was shown to cause nerve damage in lab rats.

The University of Miami Medical School, the sponsor seeking FDA approval for the human trials, said a one-time use of the ibogaine could cure addiction to heroin, cocaine and other drugs.

The drug abuse advisory committee decided that requests for human trials should be reviewed on a case-by-case basis until more information is available on its link to nerve damage.

The panel’s decision is not binding on the FDA, but the agency usually follows such advice.

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