Ibogaine Therapy
Abstract: Ibogaine is a powerful psychoactive substance that not only alters perception, mood and affect, but also stops addictive behaviors. Ibogaine has a very long history of ethnobotanical use in low doses to combat fatigue, hunger and thirst and, in high doses as a sacrament in African ritual contexts. In the 1960's, American and European self-help groups provided public testimonials that a single dose of ibogaine alleviated drug craving, opioid withdrawal symptoms, and prevented relapse for weeks, months and sometimes years. Ibogaine is rapidly demethylated by first-pass metabolism to a long-acting metabolite noribogaine. Ibogaine and its metabolite interact with two or more CNS targets simultaneously and both drugs have demonstrated predictive validity in animal models of addiction. Online forums endorse the benefits of ibogaine as an “addiction interrupter” and present-day estimates suggest that more than ten thousand people have sought treatment in countries where the drug is unregulated. Open label pilot studies of ibogaine-assisted drug detoxification have shown positive benefit in treating addiction. Ibogaine, granted regulatory approval for human testing in a Phase 1/2a clinical trial, joins the current landscape of psychedelic medicines in clinical development.
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Ibogaine is an indole alkaloid that has been used as a botanical preparation for over 100 years both as a crude preparation and as semisynthetic ibogaine. Ibogaine was marketed in France under the tradename Lambarene as a mental and physical stimulant in 8 mg tablets until 1970. In parts of Africa where Tabernanthe iboga grows, the bark of the root is chewed for various pharmacological or ritualistic purposes and ceremonial initiation practices of the Fang Bwiti religion. Ibogaine’s beneficial effects as an addiction treatment were discovered by heroin users, who observed that single oral doses of ibogaine rapidly alleviated opioid withdrawal symptoms and many claimed that they remained drug-free after the treatmen. Observations from the 1970's to the present have suggested that ibogaine in doses up to 1400 mg was useful for thousands of patients seeking acute drug detoxification as a means to break free from their intractable cycle of substance abuse.
In the 1990′s, NDA International was formed to advance ibogaine to the clinic based on a series of use patents describing a method for treating narcotic, psychostimulant, nicotine, alcohol and polydrug dependence with ibogaine (US Patents 4499,096; 4587,243; 4857,523). In 1993, the United States Food and Drug Administration (FDA) approved an investigator-initiated Phase 1 trial in ibogaine-experienced patients to study the pharmacokinetics (PK) and safety effects of ibogaine (IND39,680; University of Miami). This study enrolled a small number of patients before being placed on voluntary hold due to a non-study-related death that was reported following ibogaine administration in Amsterdam, Netherlands. This academic study was amended following a second in-person meeting with the FDA in 1995 to include cocaine-dependent patients. However, the United States National Institute on Drug Abuse (NIDA) opted not to fund the human Phase 1 study of ibogaine in 1995. This landmark FDA-approved clinical trial from the University of Miami was discontinued due to a lack of public or private funding...[Full Article]