(if the society has to benefit from the ibogaine)
Regardless how miraculous any healing substance and its benefits are, it has only one way to be implemented into legal medicinal use. It has to become a registered medication. Obviosly this involves much money, time and effort.
It is the only way though how to bring a substance into mainstream medicine and let the people benefit from it on a large scale . Usually this is done by the pharmaceutical companies themselves. Even if 50% of all physicians around the world would be “ibogaine-friendly”, they would be unable to use it for theraputic use, the reason being it is not a registered medication.
How can the Ibogaine or any other substance became a registered medication ?
First, there has to be pharmaceutical ibogaine which would fulfill all the requirements of the regulating authorities that release permission for conducting clinical trials, they decide if and when a certain drug would be registered as a medication or not . This pharmaceutical ibogaine has to have an official producer (contract manufacturer of pharmaceuticals) that would provide its product with a Drug Master File accompanied by a GMP Certificate (Good Manufacturer Practice Certificate). The Drug Master File containes the whole history of the substance, from its suppliers through to the steps involved to its final manufacture. The GMP certificate has to be obtained and it certifies that the product is being properly manufactured and the quality of the product is stable and controlled. Such a product can become a so called “Investigational Drug” (ID) that can be allowed to be used in clinical trials.
In order to obtain the permission to proceed with clinical trials there has to be enough Preclinical Data, which comes from studies conducted on animals. Thereafter so called Medical Writings must be prepared. These Medical Writings consist mainly of the Investigational Brochure, which containes all the available scientific data about the effects of the substance (obtained mainly from preclinical studies) and the Treatment Protocol, which states precisely how the trial is going to be conducted, i.e. number of dosages administered over a said period, size of dosages etc …
Typically, the trial is divided into 3 phases :
1st phase – the ID is administered to approx. 24 healthy volunteers. Determination of safety.
2nd phase – the ID is administered to people with the diagnosis meant to be treated using different dosages. Determination of proper treatment modalities.
3rd phase – the ID is administered to a larger number of patients than in phase 2. Determination of effectiveness.
In some cases the regulating authorities allow Treatment Protocols that combine Phase 1& 2.
The companies that specialize on conducting clinical trials are called CRO`s (Contract Research Organization). The CRO handles all organizational aspects of a clinical trial.
What`s the ibogaine`s situation on regard ?
There`s no pharmaceutical ibogaine at the time being (as far as I know of…), which could be used for trials. Me and some colleagues are currently trying to arrange suppliers of raw material and contract manufacturers that would produce it.
All the ibogaine that is currently used for treatments by the few ibogaine treatment providers all around the world comes from a very small number of laboratories, needless to say they produce it in complete anonymity, therefore their product cannot be used for any official purpose.