Quantitative GC/MS Method for Ibogaine and Primary Metab

Anecdotal human experience suggests that ibogaine (NIH 10567) is an aid in the interruptionand treatment of chemical dependency to cocaine and heroin. Ibogaine obtained from the plantTabernanthe iboga promotes in humans a state of "wakefulness and self-consciousness". At present,there is little information available on the levels of ibogaine in body fluids or on the identification of majorand/or minor metabolites. Information on the pharmacokinetics and metabolism of ibogaine is necessaryfor understanding the biological effects of the drug. We will develop and validate an analytical methodfor the identification and quantitation of ibogaine and metabolite(s) in biological specimens. Analyticalmethod development for ibogaine and metabolites will be performed under a cooperative agreement withthe University of Miami School of Medicine and the Metro-Dade County Medical Examiner Department.Significant progress has been made on the development of a simple, reliable and precise analyticalmethod using quantitative gas chromatography/mass spectrometry (GC/MS). Ibogaine has beenmeasured and a single principle metabolite has been identified in urine samples from dosed primates andhuman subjects. We will further improve upon, define and validate the analytical method. Theanalytical method will be applied to the actual assay of whole blood/plasma and urine samples providedto the project from an FDA approved Phase I pharmacokinetic trial of ibogaine currently ongoing at theUniversity of Miami School of Medicine. The proposed partnership between small business, localgovernment and academic scientists will promote the rapid development of a clinical laboratory drugtesting procedure for ibogaine.