Anecdotal human experience suggests that ibogaine (NIH 10567) is an aid in the interruption and treatment of chemical dependency to cocaine and heroin. Ibogaine obtained from the plant Tabernanthe 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 major and/or minor metabolites. Information on the pharmacokinetics and metabolism of ibogaine is necessary for understanding the biological effects of the drug. We will develop and validate an analytical method for the identification and quantitation of ibogaine and metabolite(s) in biological specimens. Analytical method development for ibogaine and metabolites will be performed under a cooperative agreement with the University of Miami School of Medlcine and the Metro-Dade County Medical Examiner Department. Significant progress has been made on the development of a simple, reliable and precise analytical method using quantitative gas chromatography/mass spectrometry (GC/MS). Ibogaine has been measured and a single principle metabolite has been identified in urine samples from dosed primates and human subjects. We will further improve upon, define and validate the analytical method. The analytical method will be applied to the actual assay of whole brood/plasma and urine samples provided to the project from an FDA approved Phase I pharmacokinetic trial of ibogaine currently ongoing at the University of Miami School of Medicine. The proposed partnership between small business, local government and academic scientists will promote the rapid development of a clinical laboratory drug testing procedure or ibogaine.Awardee's statement of the potential commercial applications of the research:An accurate and precise analytical procedure for quantification of ibogaine and noribogaine, its principal metabolite, will be required for all phases of clinical trials of iboganine. If ibogaine proves safe and effective for interrupting addiction, the analytical procedure may be used to momtor bioavailabllity of pharmaceutical preparations. Data gathered in pharmacokinetic studies may guide medicinal chemists in designing semisynthetic ibogaine derivatives with greater effectiveness and safety.National Institute on Drug Abuse (NIDA)
