IBOGAINE CLINICAL TRIAL
Researchers at the University of Miami School of Medicine were the first to be given FDA permission to conduct Ibogaine treatments in human drug-dependent volunteers. Unfortunately, these studies researching the safety of Ibogaine have not advanced due to a lack of funding.
We need to advance the study of Ibogaine in humans. The clinical study of Ibogaine is the only way that this medication will advance through the FDA, potentially making it available to the millions of people who desire to break their addictions to alcohol, cocaine and heroin.
HISTORICAL OVERVIEW OF IBOGAINE
The potential for deriving new psychotherapeutic medications from natural sources has led to renewed interest in rain forest plants for the development of anti-addiction medications. Ibogaine is an indole alkaloid found in the root bark of Tabernanthe iboga (Apocynacae family), a shrub that grows in west central Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in high doses for its psychoactive properties as a sacrament in religious rituals. Discussion of the central nervous system and cardiovascular actions of Ibogaine have appeared in scientific literature since the early 1900's.
In the 1950's CIBA Pharmaceuticals investigated Ibogaine as an anti-hypertensive agent. These studies were discontinued because the company was not convinced of its commercial viability.
After the introduction of Rauwolfia and general interest in the Apocynaceae family of which Tabernanthe iboga is a member, the pharmacology of Ibogaine was extensively studied by French pharmacologists early in the 20th century (for review, Hoffer and Osmond, 1967). These chemical, pharmacological and behavioral studies led to Ibogaine being marketed in France under the tradename Lambarene.
The putative anti-addictive properties of Ibogaine were described by groups of self-treating addicts. At the end of the Ibogaine treatment sessions, opiate and cocaine dependent subjects reported alleviation, or in some cases a cessation of drug "craving" for extended periods of time, and a few patients remained drug-free for several years thereafter. Opiate-dependent individuals reported that Ibogaine blocked the symptoms of opiate withdrawal.
An informal self-help network had provided Ibogaine treatments from 1987 until 1993 to addicts in Europe. Our research team at the University of Miami was the first to request permission from the FDA to conduct a limited Phase 1 Pharmacokinetic and Safety Trial in male subjects (IND 39,680). This clinical protocol was initially limited to include only Ibogaine veterans. In April of 1995, the FDA approved a revised clinical protocol to conduct these studies in cocaine-dependent male volunteers.
However, these dose escalation studies have not progressed beyond 2 mg/kg oral doses due to a lack of financial support for the clinical research trial.
H E A L I N G T H E A D D I C T E D B R A I N / H E A L I N G I N N E R W O U N D S