Copyright 1993 The San Diego Union-Tribune
The San Diego Union-Tribune
August 28, 1993, Saturday
LOAD-DATE-MDC: September 1, 1993
SECTION: NEWS; Ed. 1,2,3,4,5; Pg. A-19
LENGTH: 494 words
HEADLINE: Safety tests proposed for anti-cocaine medicine
BYLINE: NANCY McVICAR
Fort Lauderdale Sun-Sentinel
BODY: A drug that could shut down a drug user’s craving for cocaine or heroin may be tested at the University of Miami.
An advisory panel this week recommended that the FDA approve a limited study of the drug, ibogaine, despite concerns over possible side effects.
Dr. Juan Sanchez-Ramos, an associate professor of neurology at UM, said there was some evidence that the drug helps correct a chemical imbalance occurring in the brains of drug users.
But the UM study will only look at whether the drug is safe to take, Sanchez-Ramos said, not whether it is effective in curbing drug dependence.
After hearing about the drug last year, Sanchez-Ramos went to Holland to interview people who had taken it. He was impressed enough to want to study it at the University of Miami.
But because rats given high doses of ibogaine developed nerve damage, participation by volunteers at the university will be limited to people who already have taken the drug at least once.
The university’s switchboard was swamped yesterday by callers who wanted to volunteer for the study after CNN broadcast a brief story about ibogaine, Sanchez-Ramos said.
“But it’s already a closed study,” he said. “Most of the people are from the Northeast, mainly New York, who have already gone to Europe and taken the drug of their own accord.”
Some news reports calling the drug an “African hallucinogen” and saying it cures drug addiction with one dose are inaccurate, Sanchez-Ramos said, adding: “There’s no way one dose is going to cure anything.”
The drug, derived from the root of a West African plant, has a long history. Some tribesmen use it to stay awake and alert while hunting, Sanchez-Ramos said.
There was also some use in France early in this century, particularly among mountain climbers who reported that it improved their performance, he said.
“Some people don’t understand a therapy that would use a drug to eliminate a drug dependence,” Sanchez-Ramos said. “But it’s the same approach used in depression, treating a chemical imbalance with anti-depressants.”
The safety study, or Phase I study, is an FDA requirement for any new drug seeking approval and is expected to take at least six months after agency approval, he said. If the drug is found safe, Phase II and III studies would determine whether it works.