Winter 1994 Vol. 04, No. 3 A Time of Tests
FDA Approves Human Studies with Ibogaine The first FDA-approved studies into the physiological and psychological effects of ibogaine in humans will take place at the University of Miami under the direction of Dr. Juan Sanchez-Ramos and Deborah Mash, Ph.D. The ibogaine study is intended primarily to gather data about safety, leaving studies of efficacy for the next stage of research (assuming the drug is considered safe enough for further trials).
These trials are designed as classic dose-response studies in which the effects of very small doses of a drug are thoroughly monitored before increasingly larger doses are tested. Generally, the doses range from "too little " to "too much". Dose levels often include placebo, below any noticeable threshold, barely noticeable, less than standard, average, large, and somewhat more than is comfortable. This study design is basically the same as that used by Dr. Rick Strassman in his research with DMT, and that he will soon use in his upcoming studies of psilocybin. Dr. Charles Grob’s Phase 1 MDMA protocol is also a dose-response study. Even the medical marijuana study may also be conducted with this design.
After the Phase 1 trials with ibogaine are complete, perhaps a year or so after they begin, Phase 2 trials will start to explore the use of ibogaine in the treatment of cocaine addiction. MAPS made a small donation of $1,000 to support Drs. Sanchez-Ramos and Mash in their efforts to secure FDA-approval for the ibogaine protocol. It was a pleasure to direct some of MAPS’ limited resources to the ibogaine project. The study of the use of psychedelics in the treatment of substance abuse is one of the most powerful ways of contributing to a cultural shift away from demonizing drug addicts, and psychedelic drugs. Perhaps in time we will see a popular recognition that both drug addicts and psychedelic drugs may yet have positive contributions to make to society when given the option of supportive cultural contexts.