Rafael Guimarães dos Santos is a Postdoctoral Fellow in the Department of Neurosciences and Behavior, Ribeirão Preto Medical School, University of São Paulo, where he is part of the team investigating the antidepressive and anxiolytic effects of ayahuasca. He is also on the board of ICEERS, a philanthropic, tax-exempt non-profit organization dedicated to the integration of ayahuasca and other traditional plants as therapeutic tools in modern society, and the preservation of the indigenous cultures that have been using these plant species since antiquity on their habitat and botanical resources.
1. Tell us a bit about yourself and how you came to researching ibogaine?
I have a PhD in Pharmacology and have specialised in the human psychopharmacology of hallucinogenic compounds such as ayahuasca, psilocybin and LSD, and also of other compounds such as the cannabinoids. In the last years I have coordinated and participated in clinical trials with ayahuasca in both healthy volunteers and people with anxiety disorders. The interest in ibogaine is associated with these topics.
2. When did you first come across ibogaine?
In the early 2000’s, when I was doing by Bachelor in Biology and started to study this compound.
3. What is the legal status of ibogaine in Brazil?
According to ANVISA (Agência Nacional de Vigilância Sanitária, or Brazilian Health Regulatory Agency), the Brazilian agency responsible for the regulation and approval of pharmaceutical drugs:
“…Thus, since ibogaine does not have or have been registered, it was not evaluated by ANVISA as safety and efficacy, and can not be commercialized in Brazil. Import is possible for conducting clinical research (…with the strict purpose of research and medical and scientific work).”
“If there are clinics or internet sites that offer or sell the product, it is something that is not regulated”.
4. Tell us about the phase 2 clinical trial that you are about to undertake with ibogaine contra alcoholism? What are you hoping to find out?
In Brazil and South America alcohol misuse is a very serious problem, and there are no effective treatments. Ibogaine showed potential in preclinical studies and in observational studies in humans. It should be investigated further.
We will conduct the study under the supervision of Prof. Jaime Hallak, from the Department of Neurosciences and Behaviour, at the Ribeirão Preto Medical School, Universidade de São Paulo.
We will evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients. Patient will receive 3 increasing doses of ibogaine (20-400 mg) with follow-up visits 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs. See details here: ClinicalTrials.gov Identifier: NCT03380728.
We hope to find that it is safe and effective to administer low and increasing doses of ibogaine to this clinical population. We will start with 12 volunteers.
5. If the study is successful, how would phase 3 – the most expensive phase – be funded?
We are not thinking in phase 3 trials at this moment, we first have to complete this phase 2 trial. One step at a time.
6. What are the timelines for the phase 2 trial, and how long would phase 3 take, approximately?
As soon as we have the ibogaine the study should be completed in around 2 years, but that is difficult to define. There are many factors, such as hospital dynamics, that we do not control.
We are not thinking in phase 3 trials at this moment.
7. Given that ibogaine remains Schedule 1 in the US, do you think that the way forwards for ibogaine medicalisation will have to come from other countries, like Brazil? Or do you think FDA approval ultimately will be required for global medicalisation?
I do not know, we are not trying to transform ibogaine in a medicine, that is not our goal. We will investigate its effects scientifically to try understand not only its possible beneficial effects, but also to know more clearly what are its possible negative effects and with which doses negative effects are more common than beneficial effects.
We are not thinking about the FDA and do not need it to do our studies.
8. What is your vision for ibogaine in the future?
I hope that we can have more solid, rigorous, and standardised information regarding which dose or doses of ibogaine are beneficial to patients with different drug-related problems, and that we can better understand its negative effects to try to reduce (or stop) the occurrence of life-threatening situations related to ibogaine.