Phase 1 Clinical Trial of Ibogaine in Human Patient Volunteers Phase 1 Clinical Trial of Ibogaine in Human Patient Volunteers: Progress Notes from the University of Miami
Deborah C. Mash, Ph.D.
Associate Professor of Neurology and Molecular and Cellular Pharmacology The University of Miami Ibogaine Research Team is conducting Phase I clinical studies with Ibogaine.
Ibogaine is a psychoactive indole alkaloid from the rain forest shrub Tabernanthe iboga. Ibogaine is one of a dozen or more alkaloids found in the iboga shrub that grows in West Africa. Ibogaine has gained attention as an alternative lead compound for the development of anti-addiction medications. The use of ibogaine for the treatment of drug dependence has been based on anecdotal reports from the International Coalition for Addict Self-Help (ICASH) and DASH (Dutch Addict Self-Help Group) that it may decrease the signs of opiate withdrawal and reduce drug craving for cocaine and heroin. Preclinical studies in animals have given additional support to the claim that ibogaine is an addiction interrupter. While much of the information has been promising, the pace of human clinical trials and research with ibogaine has been considerably slow tracked by the lack of any significant financial support. This failure is surprising given the initial enthusiasm for Ibogaine as a medication to treat cocaine and heroin addiction. The question of whether or not ibogaine is indicated as a pharmacotherapy for promoting cocaine abstinence or interrupting heroin or other substance abuse disorders will require controlled clinical trials in humans. The decision to begin human use of a drug is often difficult. The reasonableness of the risk that subjects are asked to assume is often controversial, as may be the appropriateness of the safety monitoring. Beginning in the 1960s and continuing to the present, interest in the use of ibogaine as a treatment for drug dependence has grown. With this interest, self-help networks of addicts have used the drug in Europe and Central America. The Drug Advisory Committee of the FDA has reviewed all of the available preclinical and clinical data and approved the continuation of a Phase 1 Pharmacokinetic and Safety Trial (IND 39,680) in cocaine dependent patient volunteers.
Grant proposal submitted to NIDA
Drug dependence is defined as a cluster of cognitive, behavioral, and physiologic symptoms that indicate a person has impaired control of psychoactive substance use and continues use of the substance (cocaine, heroin, alcohol) despite adverse consequences. From the reports of humans with cocaine and heroin addictions who have taken ibogaine, it seems that several features of the ibogaine experience may be important for interrupting intractable patterns of drug-seeking behavior. We have submitted a grant proposal to the National Institute on Drug Abuse requesting funds to conduct a controlled Phase 1 clinical trial of ibogaine in cocaine-dependent patient volunteers. This grant proposal is designed to assess safety, pharmacokinetics and dosage effects. We also plan to conduct longitudinal follow-up and standardized data collection in order to identify relevant parameters of efficacy to guide the design of future Phase 2 trials. The grant application includes a group of expert investigators from the University of Miami School of Medicine and the University of California at San Francisco. These investigators are joined by substance abuse treatment and pharmaceutical consultants from industry, academia and the private sector. We have obtained the support of a local Substance Abuse Treatment Community provider also to work with us on this project. These arrangements will ensure successful completion and adequate follow-up on patient volunteers that have agreed to participate in the study.
Project on hold
The Miami group is very grateful to MAPS for providing continued support for the Ibogaine Research Project when other sources of private or public funds were not available. The $25,000 in research funds provided by MAPS have directly supported the clinical studies of ibogaine's safety and metabolism in human patient volunteers as part of the Phase I protocol. The MAPS funding allowed us to obtain important preliminary data to support our grant application that is now pending review. The review of the grant entitled "Ibogaine; Human Phase 1 Clinical Trial" will not be completed until the end of the summer. The earliest possible funding date for this project is September / October 1996. Until then, the Ibogaine Research Project will stay on hold pending the results of the NIH review process. No other funds are available to continue this important work in the absence of public support from the NIH.
Private contribution to the Ibogaine Research Project may be made payable to:
the Addiction Research Fundor to MAPS.
(att: Dr. D. Mash)
the Univ. Miami School of Medicine
1501 NW 9 Ave.
Miami, FL 33101