bom dia, buenos dias, good morning ok, what i'd like to do today is to share our work and effort in brazil to advance ibogaine therapy for drug addiction in our case, the problem there is not opiates but cocaine and crack cocaine we've been working in this for some 3 or 4 years and we are now prety much ready
to start a very good, rigorous clinical trial which i'll talk in the end so i put the title as regulating a treatment with ibogaine so there are two important things why i put this title one is that ibogaine is not a treatment by itself ok? so everything i'm going to show
happened with psychotherapy before and psychotherapy after, right? and second, it is our goal to have a treatment regulated and recognized by the government so it can be accessible to more people so when we're talking about ibogaine i think it's important to pay some tribute to those that began this
howard lotsof, it was an honor to listen to his wife norma yesterday and if you go to consider the peer-reviewed scientific literature until 2006 there was this paper claiming that 3400 people have undergone ibogaine treatment people here in this conference talk about a much larger number
but before i proceed i think it's important for us to consider the differences very important differences between ibogaine and iboga we can never, from the pharmacological point of view should never confuse a molecule, a substance with its plant source, right?
the plant, we saw yesterday the iboga plant contain many other alkaloids that may have different effects there are different types of iboga plant from what we learned yesterday at least seven different types of plants and i think we should make an effort to be more precise using the words so if you're working with the plants
or with total alkaloid extracts and things like that you should not say you're doing ibogaine treatment because it creates and perpetuates confusion ok? and this has to do with the safety thing that was also spoken yesterday but furthermore
when we're talking about plants we're talking about a live organism we're talking about culture we're talking about ritual and lots of other things that appeared yesterday and when we are talking about molecules it tend to be the phd guys in white coats but i don't necessarily see these things as being in tension,
or disrespect to each other i think that biotechnology can work cooperatively with the sustainability and with respect to the traditions at least this is the approach we try to do with plantando consciencia so when we're talking about iboga and ibogaine we have this safety issue
that needs to be further investigated in our case, the clinical trial we'll also do this which mainly relates to arrhythmias cardiac arrhythmias that can be fatal probably because of prolongation of the qt interval in the electrocardiogram so this is very very important
to be studied in depth and we want to do this soon and it is probably related it's the best explanation in medicine so far for the unfortunate fatalities that are recorded in the literature so according to the best paper in this a review by professor alper
who is here in the conference a 2012 paper they cataloged 19 fatalities which they called, wisely called "temporally related fatalities to ibogaine" so these cases happened between 1.5 to 72 hours after taking the ibogaine so some of them were not acute since the publication of this paper
we have at least 2 more cases in the peer-reviewed literature one of them involving a patient with methadone which the post-mortem data revealed that the patient had high doses of methadone and benzodiazepine when he took the ibogaine so that might be a helpful explanation for this fatality
if we divide this by the 3400 cases we get approximately 0.6% less than 1% of the ibogaine treatments resulting in fatalities this is probably lower because as i said, many more treatments are happening that are not recorded in the peer reviewed literature regarding the medical potential we just heard the experts here
ibogaine is much more known very well known treatment to reduce opioid cravings and to help patients in heroine or methadone what we published in 2014 i hope you know the paper i'll just describe a brief resume it's published in the journal of psychopharmacology we did a retrospective study
i interviewed 75 drug abusers and drug dependent patients they used alcohol, cigarettes i don't like saying tobacco tobacco is a different thing is a plant, it has all the other issues it is a sacred plant by itself cannabis or marijuana or maconha or whatever you wanna call it
and cocaine or crack so around 70% of our sample we can call them polydrug users they used many of these drugs but for most of them the real problem in their life was crack and cocaine these patients started very soon the average age of onset
was ten years old for alcohol eleven years old for cigarettes 13 years old for cannabis and around 15 for cocaine if we go for the minimun there was a patient that started drinking alcohol as early as seven years old they had many many attempts to treat themselves in many different treatment modalities
for drug addiction the median was four previous attempts of treatment so this people were not like easy, like people trying drugs and trying this outlandish thing this ibogaine thing these were people with heavy suffering that the medical system could not help
and then they decided for some alternative and what we found was for eight women in the sample they were all found abstinent when we contacted them and from 67 men we found 72% of them abstinent at the time of contact so we could say the treament
was effective for 70% of the men and 100% of the women although the number of women is pretty low however some ten or eleven of the men that were abstinent when i interviewed them they were doing other treatments if you wanna be conservative and say well, if he's doing another treatment the ibogaine treatment failed
then we go for 57% success in men these numbers are extraordinarily high in the treatment of addiction specially to psychostimulants like cocaine and crack for which there is no pharmacological treatment whatsoever that medicine can offer these people so this is the first thing
and it seems to be working even more important we had no records of cardiac arrhythmias no fatalities no serious adverse event in the whole study now we have just discussed in the previous section abstinence is not everything first of all we need to see
how long were they abstinent so some of these patients most of them, took ibogaine only once some took ibogaine twice and very few took it three times and very very few more than three if we analyze after the first ibogaine session we found that people stayed abstinent for five and a half months
clinical trials for psychostimulants are celebrating results in weeks abstinent of cocaine when they get three weeks without the use of cocaine they publish a paper we're talking here about 5.5 months if we look to the data including all ibogaine sessions
this increases to 8.4 months abstinent with this treatment pretty incredible very very awesome stuff this was published in 2014 but it is not our view that abstinence is the whole story in drug dependence we really think that we need to listen to these people
we need to understand their stories to understand why they were like they were, in this situation and why did they improve so we conducted a qualitative research interviewing 21 of those for a longer time and this is the type of things they say i saw my father dying my mother crying
i saw my wedding my father hand in hand with me very beautiful i remembered my baby blanket my brother being spanked by my father then i understood him - the brother i had this very bad thing inside of me - this is a woman, i really like this quotation
and only with ibogaine i could free from it a little sad girl that lived inside of me i saw this little girl growing until it stuck to me it was myself, growing and maturing ibogaine made it crystal clear that i would die if i kept taking drugs and doing things like i was doing
i saw my deceased relatives who also had drug problems - so the patient starts realizing it is not about himself only there is a heritage transmission of behavior and suffering, trauma, intergenerational trauma it was very spiritual, i still have much to work on
- very important as well it's not like end of story you're cured, go home there is much to work on but that's what was missing i wasn't noticing the spiritual side of my life at the beggining i thought it wouldn't hit me, you know? but then it made its effect wow, i found myself you know?
for the first time in my life i saw myself without a mirror i saw myself and i kissed and i hugged myself - loving oneself, very very important for about one year and a half we're trying to publish these studies we have two papers submitted but they over and over again
they reject our studies without peer-review the editors just say no, this is not important this is not interesting this is not scientific there is no statistics in there we don't have much to learn and it will not help the community
to know the stories of the patients that used ibogaine very sad situation anyway, we used a paper in the prestigious journal addiction which defines secondary outcomes that could be used to assess drug dependence treatments beyond abstinence
and these include cravings, quality of life, psychosocial functioning family support social support and self-efficacy when we go to the qualitative reports we find that, for the group of course not for every single patient
but for the group they improved in all these domains so this shows us that there is much more that can be done with ibogaine treatments beyond maintaining people far from drug use so then there comes this question
can an ibogaine treatment be a medical solution for the crack issue? that in brazil is considered a public health emergency? for you to have an idea the federal government planned to spend in 2013 12 billion reais you divide this by 4
and you have this in dollars like 3 billion dollars in actions education and programs and therapies that we know that don't work to try to solve this thing and then we sent them our clinical trial asking for money and they ignored us they don't even reply
it's a very complicated situation anyway, we are keeping strong in this we have a good team there are some brazilians here helping me out we are going to find the way to do this we will find the necessary resources and we already have
our clinical trial protocol double blind, randomized, placebo controlled to use ibogaine hydrochloryde with previous psychotherapy post-session integrative psychotherapy and all standardized measures so we have published and standard psychiatric rating scales
to assess abstinence, cravings quality of life all those measures we have the psychedelic questionnaires like the hallucinogen rating scale the states of consciousness questionnaire to look more in depth to what happens during the ibogaine and to try to correlate that over time
we have a cardiologist onboard we are going to do 24 hour cardiac monitoring we're gonna study what happens with the qt interval if there is any arrhythmia how it relates to the baseline of each patient we're gonna periodically collect blood samples so we can quantify ibogaine and noribogaine in the plasma
we can do a time curve and we can relate these to ecg and to the therapeutic effects this is how i see we can move a little bit in the direction of causality so if we have any arrhythmia we'll have the plasma data to look at to see if it correlates with ibogaine or noribogaine
rising up in the blood, in the system so i'm really happy and glad we're making these advances i'm firmly convinced we can get the funds this year and we can start this hopefully next semester we can quite easily import ibogaine from phytostan in canada
the whole work bruno [rasmussen chaves] will present tomorrow from this retrospective study was done from ibogaine hcl from phytostan we can get it for the clinical trial there is not much bureaucracy involved from our part and the protocol is already submitted
to an ethical review board it's ongoing we should get approval in around two months and you can contribute to this and please do! ok? we can cooperate in many ways we're starting also an mdma pilot phase 2 study for ptsd
for which we did a crowdfunding in brazil and raised like 50 thousand reais which is about 12 thousand dollars in a month and i believe if we could organize we can raise funds for ibogaine research and this would be one of the beautiful consequences of a conference like this
we are also negotiating in other forms we have this, we have this small flyers like this, over there next to that banner please take more than one take it with you, distribute it around help us to reach more people, so we can make this happen
and hopefully bring ibogaine therapy to the next level which i think is the dream of many present here today thank you
to start a very good, rigorous clinical trial which i'll talk in the end so i put the title as regulating a treatment with ibogaine so there are two important things why i put this title one is that ibogaine is not a treatment by itself ok? so everything i'm going to show
happened with psychotherapy before and psychotherapy after, right? and second, it is our goal to have a treatment regulated and recognized by the government so it can be accessible to more people so when we're talking about ibogaine i think it's important to pay some tribute to those that began this
howard lotsof, it was an honor to listen to his wife norma yesterday and if you go to consider the peer-reviewed scientific literature until 2006 there was this paper claiming that 3400 people have undergone ibogaine treatment people here in this conference talk about a much larger number
but before i proceed i think it's important for us to consider the differences very important differences between ibogaine and iboga we can never, from the pharmacological point of view should never confuse a molecule, a substance with its plant source, right?
the plant, we saw yesterday the iboga plant contain many other alkaloids that may have different effects there are different types of iboga plant from what we learned yesterday at least seven different types of plants and i think we should make an effort to be more precise using the words so if you're working with the plants
or with total alkaloid extracts and things like that you should not say you're doing ibogaine treatment because it creates and perpetuates confusion ok? and this has to do with the safety thing that was also spoken yesterday but furthermore
when we're talking about plants we're talking about a live organism we're talking about culture we're talking about ritual and lots of other things that appeared yesterday and when we are talking about molecules it tend to be the phd guys in white coats but i don't necessarily see these things as being in tension,
or disrespect to each other i think that biotechnology can work cooperatively with the sustainability and with respect to the traditions at least this is the approach we try to do with plantando consciencia so when we're talking about iboga and ibogaine we have this safety issue
that needs to be further investigated in our case, the clinical trial we'll also do this which mainly relates to arrhythmias cardiac arrhythmias that can be fatal probably because of prolongation of the qt interval in the electrocardiogram so this is very very important
to be studied in depth and we want to do this soon and it is probably related it's the best explanation in medicine so far for the unfortunate fatalities that are recorded in the literature so according to the best paper in this a review by professor alper
who is here in the conference a 2012 paper they cataloged 19 fatalities which they called, wisely called "temporally related fatalities to ibogaine" so these cases happened between 1.5 to 72 hours after taking the ibogaine so some of them were not acute since the publication of this paper
we have at least 2 more cases in the peer-reviewed literature one of them involving a patient with methadone which the post-mortem data revealed that the patient had high doses of methadone and benzodiazepine when he took the ibogaine so that might be a helpful explanation for this fatality
if we divide this by the 3400 cases we get approximately 0.6% less than 1% of the ibogaine treatments resulting in fatalities this is probably lower because as i said, many more treatments are happening that are not recorded in the peer reviewed literature regarding the medical potential we just heard the experts here
ibogaine is much more known very well known treatment to reduce opioid cravings and to help patients in heroine or methadone what we published in 2014 i hope you know the paper i'll just describe a brief resume it's published in the journal of psychopharmacology we did a retrospective study
i interviewed 75 drug abusers and drug dependent patients they used alcohol, cigarettes i don't like saying tobacco tobacco is a different thing is a plant, it has all the other issues it is a sacred plant by itself cannabis or marijuana or maconha or whatever you wanna call it
and cocaine or crack so around 70% of our sample we can call them polydrug users they used many of these drugs but for most of them the real problem in their life was crack and cocaine these patients started very soon the average age of onset
was ten years old for alcohol eleven years old for cigarettes 13 years old for cannabis and around 15 for cocaine if we go for the minimun there was a patient that started drinking alcohol as early as seven years old they had many many attempts to treat themselves in many different treatment modalities
for drug addiction the median was four previous attempts of treatment so this people were not like easy, like people trying drugs and trying this outlandish thing this ibogaine thing these were people with heavy suffering that the medical system could not help
and then they decided for some alternative and what we found was for eight women in the sample they were all found abstinent when we contacted them and from 67 men we found 72% of them abstinent at the time of contact so we could say the treament
was effective for 70% of the men and 100% of the women although the number of women is pretty low however some ten or eleven of the men that were abstinent when i interviewed them they were doing other treatments if you wanna be conservative and say well, if he's doing another treatment the ibogaine treatment failed
then we go for 57% success in men these numbers are extraordinarily high in the treatment of addiction specially to psychostimulants like cocaine and crack for which there is no pharmacological treatment whatsoever that medicine can offer these people so this is the first thing
and it seems to be working even more important we had no records of cardiac arrhythmias no fatalities no serious adverse event in the whole study now we have just discussed in the previous section abstinence is not everything first of all we need to see
how long were they abstinent so some of these patients most of them, took ibogaine only once some took ibogaine twice and very few took it three times and very very few more than three if we analyze after the first ibogaine session we found that people stayed abstinent for five and a half months
clinical trials for psychostimulants are celebrating results in weeks abstinent of cocaine when they get three weeks without the use of cocaine they publish a paper we're talking here about 5.5 months if we look to the data including all ibogaine sessions
this increases to 8.4 months abstinent with this treatment pretty incredible very very awesome stuff this was published in 2014 but it is not our view that abstinence is the whole story in drug dependence we really think that we need to listen to these people
we need to understand their stories to understand why they were like they were, in this situation and why did they improve so we conducted a qualitative research interviewing 21 of those for a longer time and this is the type of things they say i saw my father dying my mother crying
i saw my wedding my father hand in hand with me very beautiful i remembered my baby blanket my brother being spanked by my father then i understood him - the brother i had this very bad thing inside of me - this is a woman, i really like this quotation
and only with ibogaine i could free from it a little sad girl that lived inside of me i saw this little girl growing until it stuck to me it was myself, growing and maturing ibogaine made it crystal clear that i would die if i kept taking drugs and doing things like i was doing
i saw my deceased relatives who also had drug problems - so the patient starts realizing it is not about himself only there is a heritage transmission of behavior and suffering, trauma, intergenerational trauma it was very spiritual, i still have much to work on
- very important as well it's not like end of story you're cured, go home there is much to work on but that's what was missing i wasn't noticing the spiritual side of my life at the beggining i thought it wouldn't hit me, you know? but then it made its effect wow, i found myself you know?
for the first time in my life i saw myself without a mirror i saw myself and i kissed and i hugged myself - loving oneself, very very important for about one year and a half we're trying to publish these studies we have two papers submitted but they over and over again
they reject our studies without peer-review the editors just say no, this is not important this is not interesting this is not scientific there is no statistics in there we don't have much to learn and it will not help the community
to know the stories of the patients that used ibogaine very sad situation anyway, we used a paper in the prestigious journal addiction which defines secondary outcomes that could be used to assess drug dependence treatments beyond abstinence
and these include cravings, quality of life, psychosocial functioning family support social support and self-efficacy when we go to the qualitative reports we find that, for the group of course not for every single patient
but for the group they improved in all these domains so this shows us that there is much more that can be done with ibogaine treatments beyond maintaining people far from drug use so then there comes this question
can an ibogaine treatment be a medical solution for the crack issue? that in brazil is considered a public health emergency? for you to have an idea the federal government planned to spend in 2013 12 billion reais you divide this by 4
and you have this in dollars like 3 billion dollars in actions education and programs and therapies that we know that don't work to try to solve this thing and then we sent them our clinical trial asking for money and they ignored us they don't even reply
it's a very complicated situation anyway, we are keeping strong in this we have a good team there are some brazilians here helping me out we are going to find the way to do this we will find the necessary resources and we already have
our clinical trial protocol double blind, randomized, placebo controlled to use ibogaine hydrochloryde with previous psychotherapy post-session integrative psychotherapy and all standardized measures so we have published and standard psychiatric rating scales
to assess abstinence, cravings quality of life all those measures we have the psychedelic questionnaires like the hallucinogen rating scale the states of consciousness questionnaire to look more in depth to what happens during the ibogaine and to try to correlate that over time
we have a cardiologist onboard we are going to do 24 hour cardiac monitoring we're gonna study what happens with the qt interval if there is any arrhythmia how it relates to the baseline of each patient we're gonna periodically collect blood samples so we can quantify ibogaine and noribogaine in the plasma
we can do a time curve and we can relate these to ecg and to the therapeutic effects this is how i see we can move a little bit in the direction of causality so if we have any arrhythmia we'll have the plasma data to look at to see if it correlates with ibogaine or noribogaine
rising up in the blood, in the system so i'm really happy and glad we're making these advances i'm firmly convinced we can get the funds this year and we can start this hopefully next semester we can quite easily import ibogaine from phytostan in canada
the whole work bruno [rasmussen chaves] will present tomorrow from this retrospective study was done from ibogaine hcl from phytostan we can get it for the clinical trial there is not much bureaucracy involved from our part and the protocol is already submitted
to an ethical review board it's ongoing we should get approval in around two months and you can contribute to this and please do! ok? we can cooperate in many ways we're starting also an mdma pilot phase 2 study for ptsd
for which we did a crowdfunding in brazil and raised like 50 thousand reais which is about 12 thousand dollars in a month and i believe if we could organize we can raise funds for ibogaine research and this would be one of the beautiful consequences of a conference like this
we are also negotiating in other forms we have this, we have this small flyers like this, over there next to that banner please take more than one take it with you, distribute it around help us to reach more people, so we can make this happen
and hopefully bring ibogaine therapy to the next level which i think is the dream of many present here today thank you
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