Ibogaine and the FDA

NCTR 2002-2003 Research Plans – Neurotoxicology

Title: Effects of Ibogaine on Neurotransmitter Systems, Generation of Free Radicals and Nitric Oxide Synthase Activity: Correlation with Neurohistological Evaluations in Mouse and Rat Brain Determine the effects of ibogaine on dopamine, serotonin and their metabolite concentrations in different regions of mouse and rat brain;
http://www.fda.gov/nctr/science/02-03_research_plans/html/neurotox.html
Medical Possibilities for Psychedelic Drugs
In the Baltimore study, scientists are examining LSD as a possible treatment for addiction to heroin, opium, alcohol, and sedative hypnotics. University of Miami researchers are studying the psychedelic drug ibogaine to treat cocaine addiction. Other scientists are focusing their psychedelic research on learning more about the human brain, discovering antidotes to drug overdoses, and relieving pain in cancer patients. The drugs are known more for their abuse potential. They include, in addition to LSD and ibogaine, mescaline, MDMA (3-4-methylenedioxymethamphetamine–commonly called “Ecstasy”), DMT (dimethyltryptamine–known on the street as “Businessman’s Special”), PCP (“Angel Dust”), N,N-diethyltryptamine (DET), psilocybin, psilocin, and alpha-ethyltryptamine (alpha-ET–also known on the street as “Trip” and “ET”).
http://www.fda.gov/fdac/features/795_psyche.html
SAli Biosketch
Baumann, M.H., Rothman, R.B. and Ali, S.F Comparative neurobiological effects of ibogaine and MK-801 in rats. Drug and Alcohol Dependence 59, 143-151, 2000. Ali, S.F., Thiriet, N. and Zwiller, J. Acute ibogaine injection induces expression of the immediate early genes, egr-1 and c-fos, in mouse brain. Molecular Brain Res. 74, 237-241, 1999.
http://www.fda.gov/nctr/staff/bios-html/sali.html
2001 FDA Science Forum Poster Abstract: Binienda
Spectral analysis of electroencephalogram (EEG) in ibogaine and domoic acid neurotoxicity assessment. Rapid advances in computer technology have allowed expansion of quantitative electroencephalography (EEG) techniques in neurotoxicology. EEG is applied to assess spontaneous electrocerebral activity using either scalp electrodes or electrodes implanted in specific brain regions. Ibogaine (IBO) and domoic acid (DOM) are both of interest to FDA because of their potential to produce neurotoxicity. Here, cortical EEG (ECoG) was monitored in adult, male Sprague-Dawley rats injected with IBO, cocaine and IBO or DOM. Frequency analysis based on the fast Fourier transform (FFT) technique revealed that IBO at a high dose decreased threshold for cocaine induced seizures. Rats treated with DOM had the seizures along with a significant increase in the low frequency ECoG. The results indicate that noninvasive, spectral EEG analysis may represent a useful approach in neurotoxicity assessment.
http://www.cfsan.fda.gov/~frf/forum01/A033T06b.htm
AScallet Biosketch
Scallet, A.C., Ye, X., Rountree, R.L., Nony, P. and S.F. Ali. Ibogaine produces neurodegeneration in rat, but not mouse, cerebellum: neurohistological biomarkers of Purkinje cell loss. Ann. N.Y.A.S. 801:217-226, 1996. Xu, Z., Chang, L.W., Slikker, W Jr., Ali, S.F., Rountree, R.L. and Scallet, A.C. “A dose-response study of ibogaine-induced neuropathology in the rat cerebellum”. Toxicological Sciences, 57:95-101, 2000.
http://www.fda.gov/nctr/staff/bios-html/ascallet.html
FDA > CDRH > CFR Title 21 Database Search
Some trade or other names: DMT (19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439. (20) Ibogaine……………………………………………. 7260 Some trade or other names: DMT (19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439. (20) Ibogaine……………………………………………. 7260
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1308.11
1996-97 Research Plans Document – Neurotoxicology Division
Several research projects in the various focal research areas are scheduled for initiation in FY97. Within the excitatory amino acid area, domoic acid-induced effects will be evaluated in the developing rat (collaboration with CFSAN). In addition, after the recent publication of a new sensitive and reliable fluorescent method for revealing neuronal degeneration and a simple, sensitive and reliable metallic stain for demonstrating myelin pathologies, a new research focal area on neurohistological technique validation has been initiated. In the monoamine focal area, the influence of body temperature on d-fenfluramine induced neurotoxicity will be further explored and studies on this and other stimulants (e.g., methylphenidate) will be completed (collaboration with CDER). For the energy disruption focal area, data demonstrating the utility of animal models for the study of anti-HIV therapeutics (e.g., ddI and ddC) will be published (collaboration with NIEHS and CDER). Also, methods for detecting brain levels of d-fenfluramine and its active metabolite will be published to improve risk assessment procedures for this agent. The time to onset of the histologically verified peripheral neuropathy induced by ddI will also be resolved. Two new protocols, one to examine the fetal disposition of 3′-azido-3′-deoxythymidine (AZT) and dideoxy-didehydrothymidine (d4T), and another to evaluate the monkey as a model to study the peripheral neuropathy-producing effects of thalidomide and ddC, will be completed in collaboration with NIEHS and CDER. In the oxidative stress focal area, studies of the effects of manganese on the nervous system in the adult and developing rat will be completed and published (collaboration with CFSAN). A recently approved protocol that focuses on the neurotoxicity potential of Ibogaine will be initiated. In collaboration with CFSAN, 3-nitropropionic acid (3-NPA), a food-borne agent known to produce mitochondrial dysfunction, will be used in an attempt to develop a chemically induced rat model of “ischemic hypoxia.” In the interspecies extrapolation and validation of animal models focal area, validation studies on the acute effects of representative drugs in the NCTR operant test battery will continue in the monkey and rat as will studies on the chronic effects of the prototypic drugs (e.g., methylphenidate) used in the treatment of attention deficit and hyperactivity disorder (ADHD). Results on the use of the NCTR operant test battery for the assessment of normal and ADHD children will be published. The importance of the interdisciplinary mechanistically-based approach of neurotoxicology research is that it encourages the development of in-depth, integrated knowledge bases and techniques that will be useful in addressing problems associated with current (e.g., thalidomide, fumonisin [FB1], domoic acid, methylphenidate, fenfluramine, ibogaine, and fluoxetine) and future agents of regulatory concern.
http://www.fda.gov/nctr/science/96-97%20research%20plans/organizations/neurotox.htm
NCTR 1996-97 Research Plans – Chemicals Referenced
Ibogaine
http://www.fda.gov/nctr/science/96-97%20research%20plans/chemicals.htm
FDA > CDRH > CFR Title 21 Database Search
Some trade or other names: DMT (19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439. (20) Ibogaine……………………………………………. 7260 Some trade or other names: DMT (19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439. (20) Ibogaine……………………………………………. 7260
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1305&showFR=1&subpartNode=21:9.0.1.1.6.3
2001 FDA Forum Poster Abstracts – by Author
Spectral analysis of electroencephalogram (EEG) in ibogaine and domoic acid neurotoxicity assessment.
http://www.cfsan.fda.gov/~frf/forum01/abst01na.html
PART B – AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES
(8) Ibogaine.
http://www.fda.gov/opacom/laws/cntrlsub/cntlsbb.htm

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