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Episode 616
The Doctor's Farmacy

Are Psychedelics The Solution To The Opioid Crisis?

Open the Podcasts app and search for The Doctor’s Farmacy. If you’re viewing this site on your phone, you can just tap on the

Tap the subscribe button and new shows will be added to your library.

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If you or a loved one struggle with addiction, this is an episode you’re going to want to listen to. 

Many of our current pharmaceuticals stem from compounds discovered in plant medicines. And many beneficial plants that were discovered decades ago still have huge potential for changing modern medicine—ibogaine is one of them. 

Today on The Doctor’s Farmacy, I’m excited to sit down with Dr. Deborah Mash to discuss the use of the African plant ibogaine and its metabolite, noribogaine, in the treatment of addiction and how it could impact the devastating opioid epidemic. 

We dive into this episode with a history of ibogaine and how it can work to reset opioid tolerance and bypass withdrawal symptoms in a single dose. Dr. Mash shares how she’s seen addicts have incredible recovery stories after just one ibogaine treatment. 

Addiction involves many components, so recovery should as well. Dr. Mash and I discuss the benefit of ibogaine as an “addiction interrupter,” to kick-start the recovery process, and how combining it with other healing modalities such as trauma therapy could lead to reductions in relapse and better long-term outcomes. 

We’re in a really exciting time, a renaissance of psychedelic medicines that we can harness to change synaptic plasticity in the brain. This is an interesting conversation and I think it provides hope for the future of addiction treatment. 

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I hope you enjoyed this conversation as much as I did. Wishing you health and happiness,
Mark Hyman, MD
Mark Hyman, MD

Here are more of the details from our interview (audio):

  1. The long history of ibogaine’s ethnobotanical and ethnopharmacologic use
    (7:01)
  2. The power of ibogaine to reset opioid tolerance and bypass many withdrawal symptoms in a single dose
    (15:41)
  3. How ibogaine works
    (20:59)
  4. Using ibogaine as to protect against future relapse
    (26:09)
  5. Efforts to understand the importance of ibogaine’s psychedelic effects
    (30:05)
  6. Assessing the success rates of recovery and relapse preventions from ibogaine treatment
    (37:49)
  7. Understanding the underlying drivers of addiction for better recovery and relapse treatment
    (41:46)
  8. The concept of “psychoplastogens” and turning on synaptic plasticity in the brain
    (51:44)
  9. Human’s relationship to plants and plant medicines
    (57:25)
  10. Risks associated with, and considerations for seeking ibogaine treatment
    (1:03:24)

Guest

 
Mark Hyman, MD

Mark Hyman, MD is the Founder and Director of The UltraWellness Center, the Head of Strategy and Innovation of Cleveland Clinic's Center for Functional Medicine, and a 13-time New York Times Bestselling author.

If you are looking for personalized medical support, we highly recommend contacting Dr. Hyman’s UltraWellness Center in Lenox, Massachusetts today.

 
Dr. Deborah Mash

Dr. Deborah Mash is one of the world’s foremost experts on ibogaine. She is the CEO and Founder of DemeRx Inc., a clinical-stage drug development company advancing ibogaine and its active metabolite noribogaine for the treatment of opioid use disorder. DemeRx has partnered with ATAI Life Sciences—a global biotech platform with a special focus on psychedelic medicine—to develop ibogaine for those suffering from opioid use disorder.

Building on the extensive human data available around ibogaine, DemeRx and ATAI are conducting a Clinical Phase I/II trial in opioid-dependent patients. This landmark trial will advance screening procedures, dosing guidelines, and best practices for opioid withdrawal management and relapse prevention.  

Dr. Mash is an Emeritus Professor of Neurology and Pharmacology at the University of Miami School of Medicine. She has published over 300 articles and monographs in the fields of neuroscience, pharmacology, and the neurobiology of addiction.  

 

Show Notes

  1. Learn more about Dr. Mash’s work.

Transcript Note: Please forgive any typos or errors in the following transcript. It was generated by a third party and has not been subsequently reviewed by our team.

Introduction:
Coming up on this episode of The Doctor’s Pharmacy. I’m Dr. Mark Hyman.

Dr. Deborah Mash:
Maybe these molecules are so important at a time when society is more difficult, when people are feeling more isolated, things are too fast, we don’t get off the grid enough to allow our brain to heal.

Dr. Mark Hyman:
Welcome to The Doctor’s Pharmacy. I’m Dr. Mark Hyman, I’m Dr. Mark Hyman. That’s Farmacy, with an F, a place for conversations that matter. If you or anyone you know, has struggled with addiction or mental illness and are looking for novel solutions, this podcast may be very relevant to you because it’s going to be about a compound you may never have heard about, that might just hold the key to solving addiction called Ibogaine, from the plant, Iboga. It’s with one of the world’s leading experts on Ibogaine, Dr. Deborah Mash.
I met her a number of months ago at a conference and was really blown away by the level of research and focus that she’s had over the last decades, I should say, to explore the power of this compound to heal one of the worst problems with humanity, which is addiction. She’s the founder and CEO of DemeRx, which is a clinical stage drug development company advancing, Ibogaine, and its active metabolite called Noribogaine, for the treatment of opioid use disorder.
They partnered with ATAI Life Sciences, which is a global biotech platform that’s focusing on psychedelic medicine to develop Ibogaine for those who suffer from opioid use disorder. And building on extensive human data available around Ibogaine, they are conducting a clinical Phase 1 to trial now in opioid dependent patients. This really is a landmark trial that’s going to advance screening procedures, dosing guidelines and best practices for opioid withdrawal management and preventing relapse.
She is the Merit Professor of Neurology and Pharmacology at the University of Miami’s School of Medicine. Has published over 300 articles and monographs in the field of neuroscience, pharmacology and the neurobiology of addiction. Welcome Deborah to The Doctor’s Farmacy.

Dr. Deborah Mash:
Thank you.

Dr. Mark Hyman:
Okay, well let’s get into it. This is a big problem We have, not just opioid addiction but addictions of all kind; alcohol, food addiction, gambling addiction workaholism. I certainly suffer from that. I don’t know if that would be curable by Ibogaine, but maybe. And we are now suffering with a staggering opioid epidemic. We all have heard about it. There’s over a 100,000 people who died last year, up from 75,000, from opioid overdose.
Often it starts with a legitimate pain prescription for pills that can be helpful but then gets out of control. There are 4 million people in America who are addicted to pain meds and heroin. A growing number are overdosing from a surge in these fentanyl spiked pills that are on the open drug market out there. It’s really a devastating and debilitating disease for so many people, for so many families and it’s made worse by the fact that recover rates really for addiction, using standard approaches and rehab based options, don’t work that well. I mean it’s a little bit but not that great.
I mean drugs like Methadone and Suboxone can help, but we’re really not very far ahead in the last 70, 80 years on addiction. Now you, you’ve been studying this compound from a plant, or a West African tree, the bark of a shrub, I think, native to West Central Africa, called Iboga. You told a story at this conference that I went to, which sort of heralded the discovery of this as addiction treatment medicine. Because for years and centuries maybe, it’s been used as a ritual drug in rights of initiation and passage, that are from a spiritual tradition.
But there was a discovery over 30 years ago in Amsterdam, and then you continued on in Miami and Caribbean, to actually look at this compound as being able to disrupt addiction, specifically for opioids. So can you talk about that discovery? Tell us the original story and then give us an overview of these last decades of your exploration of this, and then we’ll get into the nitty gritty of what’s going on with this research that you’re doing and the importance of this drug and this compound.

Dr. Deborah Mash:
Ibogaine has a very long history of ethno-botanical and ethno-pharmacologic use. And in fact it goes over a 100 years, because, remember prior to the development of novel pharmaceuticals, which really came about in the 1950s, most blockbuster drugs came from Mother Nature. So there was a real push primarily by the Europeans, but also Americans and others, to look to nature for finding pharmaceutical drug candidates to be advanced for treatments of a variety of illnesses; everything from infective diseases. And of course the CNS division is a little bit more complicated.
Ibogaine is an Indole alkaloid. So what does that mean? Mother Nature gives us addicting alkaloids. Addicting alkaloids are like nicotine, cocaine, opium, things that humans will take to get high, come from nature. And so here’s this molecule from Western Equatorial Africa, that’s used in low doses, for stimulating behavior, mild stimulant effect, by local people, who explored again, Mother Nature, but then in high doses, found its way into ethno-Christian religious practices in Africa, and that these were by the Bwiti religion.
So Ibogaine, like other psychedelic medicines, is a sacrament, a plant sacrament, or what we call a plant teacher. So this is the interesting legend and lore that goes back over a 100 years. But when the pharmaceutical drug hunters were in Africa. And other parts of the world, Asia et cetera, they brought back Ibogaine. And Ibogaine was really advanced in France and it made its way in low dose tablets into the French pharmacies. So many of the original pharmacies in France were able to make tinctures and potions and pills in their own shop, and Ibogaine was marketed under the trade name Lambarene, until the early 1970s.
So people took it for it’s antidepressant effects. And what we know today is that when you take a low dose of Ibogaine, it is converted to the Ibogaine active metabolite, or Noribogaine. So that experiment was done actually, for us for 20 years, in France. In the ’60s when people became interested in LSD and psilocybin, and the so-called hallucinogens, and the DEA began to clamp down on these class of drugs, there was a seminal discovery by a man named Howard Lotsof.
He died several years ago, but he has credited with this discovery. Howard was like many other people, exploring molecules for consciousness expansion. Himself was a heroin addict, and he had been abusing opioids for many years and he took a dose of Ibogaine, to experience the drug. There were groups out in California who had access to Ibogaine. It’s a difficult actual molecule to get. It’s not like mushrooms, which you can just grow. You can find Ibogaine is a little more complicated for one to access.
But he was involved in this underground movement and he was a filmmaker, young filmmaker et cetera. He takes the dose of Ibogaine and discovers that he’s detoxified off opiates. He completely abruptly stops taking opiates, has no cravings or desire to use the drug, go back out and get high to treat withdrawals, and he has no desire to use. So this was the original discovery, and he-

Dr. Mark Hyman:
When was that, Deborah?

Dr. Deborah Mash:
That was in the early ’70s when LSD was making its way from academic universities, from Harvard and elsewhere, and began that whole movement, Ibogaine had made its way into the US in a diplomatic pouch and underground therapists in California were working with it, and some people in York. So he has this experience, repeats the experience with six of his friends. Some were addicted to opiates, some were abusing cocaine, free hardcore cocaine abusers, used freebasing cocaine. And they too had similar experiences.
With that observation, it was a number of years and Howard Lotsof and a group around him, his entourage forms a company called NDA International, and they started an underground railroad of addicts helping addicts. This is what they called it, The Addict Self-Help Movement.
And so people from the United States and from Amsterdam, The International Coalition of Addict Self-Help and The Dutch Addict Self-Help Movement started to run this underground railroad, where people could go outside of Amsterdam and take Ibogaine. I leave Boston, I did my fellowship at Beth Israel Hospital and at Harvard, and joined the faculty at the University of Miami right at the peak of the cocaine epidemic in South Florida. So we were Miami Vice; cocaine was making its way through the Caribbean into Miami, and we were hit front end loading of the cocaine epidemic.
I had been working on Alzheimer’s disease and got pulled into this by my colleagues who were at the medical examiner’s office, because young people were dying from cocaine related deaths and they were dying with what we thought at the time, was rather low doses of cocaine in their blood. So people didn’t really know what was going on, and then there were some adverse psychiatric effects. We had crack exposed infants, it was a mess, increases in crime. You know the story.
I had been credited, and my laboratory, did work on Cocaethylene, and your listeners may know what that is or not, but when you drink and use cocaine in combination, your liver transesterifies, and so you’ve got an extra drug on board. You’ve got Coca [inaudible 00:11:10] Cocaethylene. We disclose this, describe it. It’s more reinforcing. It takes off the edge of the cocaine and unfortunately, it’s more lethal. So we disclose this, get national recognition and in the course of getting a lot of media attention for the work, we were called the Miami Vice Metabolite, I started hear about this drug from Africa. And it happened three times. I heard it three times.
I would say The Coalition For A Drug Free America giving a lecture about my research, and a gentleman an African American man came up to me at the podium and said, “Dr. Mash, have you heard about this drug from Africa?” And he’s going on and on. I think I was rather short with him and abrupt because I’d never heard of it. I don’t know what he was talking about.
Second time I heard about it was Stan Glick, a professor from Albany University, was working with these drug takings rats. Rats will self administer at high rates of responding, everything that humans will abuse. So they’ll drink alcohol, they’ll take nicotine, cocaine, other psycho stimulants and opiates. So he gives these rats, this drug from Ibogaine, they stopped taking drugs. I’m sitting in an audience listening to his presentation going, “Wait a minute, that’s that same molecule.”
The last thing that happened was Howard Lotsof contacted me because our laboratory was getting so much publicity, he had several patents on Ibogaine, and he wanted to file a new patent for polydrug dependency and use our research on cocaine and alcohol. So he called me and I said, “Who are you? What does this drug do? How does it work? What’s the mechanism of action?”
He said, “Want to come to Amsterdam and see it?” And I said, “Yeah, I do.” Here we are.

Dr. Mark Hyman:
So you went to Amsterdam and you actually witnessed addicts taking the drug?

Dr. Deborah Mash:
Yes.

Dr. Mark Hyman:
And the next day being symptom free from withdrawal. Now I’m a physician, and there are physiological things that happen. It’s not a psychological withdrawal. I mean there are psychological dependence and physiological dependence. And you see with addiction to, for example, alcohol. Alcoholics come in when they get off booze, they start to go on tremors, they have all kinds of symptoms. Same thing with heroin and opioids. And yet somehow this compound erases all of that, which kind of leads to a whole set of questions about what is it doing, how does it work?
I’ve even heard people share, who’ve taken the drug, that it’s like a brain reset around, not just addiction but around their personality, around their mood, around their view on life. And it just seems to sort have this really magical set of properties. It seems to go beyond just this one dose that you take to kind of deal with addiction. So how have you explored this sort of Pandora’s box of this compound that seems unlike anything else we’ve ever seen?
I mean, because there isn’t anything in medicine that works like this. You take this thing and it’s not like you have to keep taking it as a normal drugs. You don’t take a statin once and then your cholesterol’s fine forever. So how does this work and what is the theory behind it? What have you learned in the 30 years of researching this, about the mechanisms of action? Because if this is true, then it seems to be such a powerful lever for addressing the opioid addiction problem, but also other kinds of addiction.
We’ve talked about this offline, about for example, food addiction, which we know is a real phenomenon that has to do with the way the sugar affects the nucleus accumbens, the area of the brain that’s responsible for pleasure and addiction. So kind of unpack the biology of this compound, what you’ve learned

Dr. Deborah Mash:
Thank you doctor. That’s obviously a big, big black box question, and I’m quite humble in what we’ve learned about this drug. Suffice it to say I was a skeptic walking in the door, and when I saw people were able to come off of 100 milligrams of Methadone; young man, 100 milligrams of methadone, chipping on heroin, doing some benzodiazepines, some Xanax on the side, a little bit of cocaine for extra recreation on top of the Methadone, and completely be detoxified. Get up the next day, no withdrawal, shower and shave, come in, sit down and eat a big breakfast.
Because as you know, people who are coming off opiates, they don’t have an appetite, they’re very sick. So all of the just complete blockade of all of the classic opioid withdrawal symptoms that are black and white, here I was in there, seeing and believing, and the place in Amsterdam that I visited, was not what you would expect to see in an academic medical center to say, to be polite.
It was just people in different rooms in the wing of a hotel that had been taken over, who were going through detox after given one dose. I thought, “Wow, this is really scary here,” and I had brought a medical doctor, a colleague of mine, from the University of Miami, Juan Sanchez-Ramos, and I had Dr. Ramos there. But everybody went to bed. I stayed up all night. I went from bedroom to bedroom, to a hotel room to a hotel room, with three gentlemen. Two were coming off of opioids and one was coming off… One had been abusing a lot of free base cocaine.
I went from room to room, sat by their bed, watched them, gave them water. I couldn’t really do anything. There weren’t any nurses or anything there, but I had an idea. I said, “There’s no way that you can take one dose of Ibogaine, and have this complete reset, to use the word you used, which indeed it is a reset, and all the blockaded withdrawals, and people get up and look like they’ve been transformed into a new person. “There’s got to be something going on here. I’m going to collect urine.”
I collected urine and I asked them to sign a release for me to collect urine, and I froze back urine. Brought the box of urine, put it on the plane in the airport, got it on the plane, got it back to Miami, got the box, drove it over to my analytical talks group, and gave it to the boys at the bench and said, “Find the metabolite,” and that was how we discovered Noribogaine, because I was convinced that there had to be an active metabolite. That there was no way that one dose of this drug, albeit it was a large dose, could have this protracted effects on the brain and behavior. I couldn’t understand it.
So we discovered Noribogaine, and what we know today is that Ibogaine, goes through the liver, gets converted to this active metabolite, and the metabolite has a much longer half life in the blood. So Ibogaine is not only an active molecule. So the oneiric effects, the dream like visions of Ibogaine-

Dr. Mark Hyman:
Like hallucinogenic effects?

Dr. Deborah Mash:
Yeah. The psychedelic medicine effects, if you will, are short lived. So those are very intense, anywhere from about four to eight hours, depending on your liver metabolism. Whether you’re a fast, intermediate, or slow metabolizer. Then the Ibogaine is cleared from the blood. The Ibogaine is cleared from the blood in 24 hours; you’ve cleared the Ibogaine. The Noribogaine is elevated.
So in the days out you still can measure Noribogaine in the blood. The half life here is anywhere from 24 to 27 to 30 hours. So that week, you’re tailing off the Noribogaine. So I became very interested in NorIbogaine, and we also knew that you could sort of dissociate the oneiric effects.

Dr. Mark Hyman:
That means the hallucinogenic effects.

Dr. Deborah Mash:
The hallucinogenic effects of the drug. And the reason I use the oneiric is what the patients tell us is that it’s like a waking dream. So it’s that lucid dream state. People wake up from a lucid dream, and you’re in the dream, you’re conscious that you’re in the dream state, but you’re experiencing the dream state. So that is the experience. The patients tell us it’s extremely different than LSD or mushrooms or Ayahuasca for example, or MDMA, completely different.
When visionary experience hallucinations, the active waking dream state shuts off, is when the NorIbogaine peaks in the blood. So what I think today, and for many people that experience, the life review; the patients told us it was like doing a fourth step. “I relived a lot of the bad things I did on drugs, how it wrecked my family, how it wrecked me, my career, et cetera.”
There’s this insight that’s gained from having that experience. And the therapists who were with us in the Caribbean working with the patient said, “Dr Mash, this is extremely important for them. This is part of the therapeutic benefit of the drug.” So I think that Ibogaine, NorIbogaine, is like a one-two punch. Ibogaine begins the brain reset. It has effects like other psychedelic medicines on neuroplasticity and synaptic turnover and healing of the brain. So it starts the reset, it’s a little bit ketamine-like. Ibogaine is a little bit like ketamine. It’s acting on glutamates systems in the brain, so do ketamine, but it also has a serotonergic overlay.
Then the NorIbogaine is a very interesting molecule because it has effects on serotonin reuptake also. So the mood, the anti-craving and the opioid reset is likely mediated reaction of the NorIbogaine.
So when you look at the withdrawal, when you look at the stages of opioid, we’ll focus on opioids and opioid withdrawal. The acute phase, depending on the opioids that you’re abusing, can be 1 to 2, 36 to 48, to 72 hours of severe withdrawals. The Ibogaine is starting that blockade, and mitigating those symptoms. But then what patients really struggle with, they get past the acute; yeah you can take Clonidine, or Lofexidine, you can do a methadone taper. The Lofexidine and methadone taper, or what the FDA has approved for withdrawal management, there are other meds, as you well know, that are used off label, [inaudible 00:22:53]. Yes. So buprenorphine taper for example, off label.
But what patients then struggle with, because they felt horrible, they’re in a deep dark, black depression, and anhedonia, a protracted depression that doesn’t go away. And over days to weeks in early recovery, you get stress back in your life, you’re not feeling good, you can’t get out of bed, you have no energy and you are crawling out of your skin. So that protracted state, is what fuels the relapse.
So for us, the idea of having the Ibogaine, allowing people to have the journey, have this profound experience with the Ibogaine, have the reset, use that as an adjuvant to psychotherapy, use that for behavioral change, as you described well, use that in that Ibogaine initiation, to be in your group, in your therapeutic setting. And then much like MDMA is used for PTSD. You know this, people abuse drugs. Why? Because they’re self medicating. They’re medicating anxiety, intractable depression,

Dr. Mark Hyman:
Trauma.

Dr. Deborah Mash:
All the bad boogie men that take us offline as human beings, and deprive us from self actualization and the fullness of life. If we can allow patients to have that experience, to regain their self control and to find their locus self control and to feel good, and then follow the Ibogaine detoxification, with NorIbogaine, in a peel, patch or a depot in low dose formulations, we believe we have a way.

Dr. Mark Hyman:
That’s amazing. So how much of the sort reset is the process of recovery? In other words, could you just give NorIbogaine as a pill, which may have less side effects, better tolerated, easier to administer, less complicated, less expensive, and is that good enough? Or do you think we actually need the full hallucinogenic journey to reset our relationship to reality, self, life and so forth?

Dr. Deborah Mash:
That’s a fundamental question to be explored. In order to do that, we would have to, as you well know, randomize, two groups of subjects and really look at relapse prevention in both groups, and see where we are. When I originally was working on Ibogaine, I wanted to focus solely on the metabolite, because as you describe it, it will be used as a classic pharmaceutical. It would be easier for patients and practitioners can prescribe it, and we can learn about the safety, and demonstrate dose and safety effects. It may be sufficient, it may be what is needed here to allow people who have been detoxed, to transition.
But what we know today is that if you look at depression as a model, if we take depression as a model, look at college students today, I’m always amazed with the numbers of young people that are starting our universities, and coming in on anti-depressants.

Dr. Mark Hyman:
Yes, for sure.

Dr. Deborah Mash:
The numbers are staggering. Do we need that or is what people are doing, the elegant studies that are being done by COMPASS and others, with psilocybin as a rapid acting antidepressant, and as a therapeutic adjuvant for people who are having difficulty with anxiety disorders or other depression, depressed mood symptoms. In the old days, I remember when I went to college, I probably was depressed; I think my dad died and I was definitely depressed for a while. I had reactive depression, I had a little anxiety, I had fear. But what did we do? We knuckled up, you just get over it.
I used mindfulness practices, and back then, it wasn’t called out, but I did yoga and whatnot, and I just focused down. Today, everybody wants a quick fix. I think that this is, I’m enthusiastic as a neuroscientist today, with the development of the psychedelic medicines because I do think that they bring about rapid effects. We don’t know the longevity of these effects. We don’t know psilocybin, is it 90 days or longer? In some subjects it may be, some subjects maybe need one or two doses, to have protracted efficacy, and behavioral change.
With the Ibogaine, breaking the intractable cycle of addiction to anything, whether it’s opioids or whatever, is hard to do. People fall back into the hole. It’s a behavior. Would Ibogaine, and the oneiric effects, help rewire the brain? This is Vucinich and others in who… Neurons that wire together fire together. Yes, thank you doctor.
Now, I’m sitting back and kind of reopening my own view of this, and thinking, “You know what? Maybe these molecules are so important,” at a time when society is more difficult, when people are feeling more isolated, things are too fast. We don’t get off the grid enough to allow brain to heal.
I talk about orthodox, I used to give a neurobiology lecture to elderly folks, and I say, “Thing about Orthodox Judaism is that people got off the grid.”

Dr. Mark Hyman:
Or Shabbat, the Sabbath.

Dr. Deborah Mash:
Correct. You shut down for one day, spend time with family and your belief system, in a quiet, spiritual setting. How good for the brain is that? Think how smart that is, really. We don’t do that. We’re constantly, every minute, on the internet, on our phones, it’s too much. The nervous system has sensory overload. Maybe these molecules have a place, because precisely, they allow this neuroplasticity, they give us a window of plasticity.
And this idea of psychoplastagen, the term coined by David Olson, and the group at Delex Pharmaceutical, who are advancing non-hallucinogenic congeners of Ibogaine, that could be used pharmaceutically. The idea here is, can they, can others make analogs of psilocybin, Ibogaine, MDMA, et cetera, that don’t bring about the psychedelic journey experience, but turn on this window of plasticity in the brain. This is a really an exciting time because we’re learning something very fundamental about the brain. And brain has always been my… That’s my muse. I love studying the brain.
We, neuroscientists have learned more about the human brain in the last 20 years than throughout all of human history, but the answers can [inaudible 00:30:49].

Dr. Mark Hyman:
Yeah, it’s pretty extraordinary to see the sort of intersectionality of both the sort of acute, psychedelic kind of mystical aspects of personal insight and transformation that I’ve heard happen on the full dose. But then the sort of long term of addiction management and any depressing effect and maybe some other play tropic effects we haven’t even discovered, that make this sort of a long term maintenance compound for helping maintain people free of addiction. I mean, is that how you’re seeing it?

Dr. Deborah Mash:
It is. That’s exactly how we see it. Really when we were back working in Saint Kitts when I left the United States, we had gotten FDA permission to test Ibogaine in the ’90s; 1993 and 1995, the FDA gave us the full green light to bring Ibogaine forward. My issue was I couldn’t fund it. I couldn’t get NIH funding, even though I’ve been an NIH funded investigator my whole life. I could not get buy in. It was too early for people were funding these types of studies.
It was just, “Say No To Drugs,” and you’re going to treat… Can you imagine going up in front of the Congress, the head of the National Institute on Drug Abuse going, “Doctor, are you funding treating people who are addicted to hardcore drugs with a schedule one hallucinogenic drug?” “Yeah, right. No Congressman, senator. No, we’re not doing that.”
I mean I understand it, I get it. But at the time, I was so depressed myself, the FDA was so collaborative with us. Everybody says, Why doesn’t the FDA fund your studies Dr. Mash?” No, the FDA does not fund research. They guide research in drug development, but they do not pay for drug development. So my issue was getting the money, and we didn’t have the intellectual property around Ibogaine, Howard Lotsof had. So I was the odd person out here.
But when I went to Saint Kitts, and the University of Miami was again, very collaborative and always very good to me, as an investigator, and gave me the roadmap and really allowed me to do this, to go. We didn’t have people running a lot of trials. Now today, with stem cells and everything, everybody’s off into the Caribbean and elsewhere, testing in humans. Many of my colleagues are doing that.
But back when I did it, nobody was doing it. And so we really had the first government approved psychedelic clinic, working with clinicians in Saint Kitts and that’s where our safety and open label efficacy database came from. So I was able to bring those data back to my colleagues and peers, and I always had an open door policy. So I invited clinicians, more doctors, the better, who come in there and see what we were seeing. To bring that message back out. But even today, people don’t know about Ibogaine.

Dr. Mark Hyman:
Yeah, it’s pretty much under the radar for most people. This whole idea of traditional recovery medicine and rehab medicine and the success rate of that compared to what you’re seeing as the success rates with Ibogaine and even NorIbogaine treatment. Can you kind of talk about that? Because even best treatments like AA, you’re talking about 10%, 20% at best, preventing relapse. It’s pretty dismal. So how does this sort of compare to that?

Dr. Deborah Mash:
It is dismal, that is the word. And of course families have lost retirement accounts, families, to save their loved ones have put mortgages up on their houses to pay for rehabs.

Dr. Mark Hyman:
Which doesn’t really work that much.

Dr. Deborah Mash:
It doesn’t really work that much. And it breaks my heart. I mean, I speak to families all the time calling me desperate for health, and it really breaks my heart because here we are, and our work can’t go fast enough. I can’t tell you, as I sit here today, what the number is. I will never oversell my science. We don’t know because you have to do this in a so-called blinded fashion. And it’s going to be hard to blind Ibogaine against the standard of care as you know.
But what we do know is that many of our patients who detoxified with Ibogaine in the Caribbean, our counselors who were there, worked on an aftercare plan. What’s going to be doing at this time, you just detoxified, but we didn’t want people to think that this was a silver bullet because there is no silver bullet. There is no cure for addiction. Addiction’s a chronic relapsing disorder.
So what’s going to be different this time? So we sent our people back into various programs. So the outpatient, some went to inpatient, some went to meetings, 90 and 90; 90 meetings in 90 days. And a lot of our people said, “Dr. Mash, I’m never going to meetings. Forget it. I’ve done that. I’m not doing that. I’m not going to any of those meetings,” and then they would take the Ibogaine, and then they’d come back and they go, “I got to go to meetings.”
So you would see the cognition, what should we call it? Cognition enhancement, like, “Man, I got to work this thing. I’ve got to work it.” So the clinicians, I remember Doug Talbott, who ran a large treatment, was an icon in the addiction field. He called me with his therapist, because we put a few people into Talbott and he called me, he said, “Patients who are treated with Ibogaine, look like they’re 90 days clean.”

Dr. Mark Hyman:
Wow.

Dr. Deborah Mash:
He said they’re sitting in meetings, they’re engaged, they’re active, they’re planning. They’re making a plan. And this was just so exciting for us because we’re like, “Wow.” So we think that, and again, the FDA is going to give us guidance on what they want to see, to get the relapse indication in the label. Black and white on the detoxification, but the big effect is going to be exactly what you’re saying, relapse prevention. Is this really true?

Dr. Mark Hyman:
And you think it’s going to be twice effective, 10 times as effective? What’s it look like?

Dr. Deborah Mash:
I’m a gambling lady, so I would bet that the numbers are going to be really stunning, that we’re going to see an effect size that’s very large. I think others believe that too. I’m not alone here on this.

Dr. Mark Hyman:
It seems like you can deal with the addiction part and the biological piece, but what often drives addiction, and we’ve had [inaudible 00:38:01] on the podcast and others, is the underlying trauma. The trauma, whether they’re big traumas or little traumas, whether it’s abuse or neglect, that happen in people’s childhood, that drives these behaviors when they’re older.
And so often, like you said earlier, people are self-medicating. And if that’s true, then this really opens the door to start to heal for those damaged sort of circuits in our brain, but it’s not the only piece of the solution.

Dr. Deborah Mash:
No it’s not.

Dr. Mark Hyman:
So the therapy and the sort of post work, if you will, around the treatment of addiction after Ibogaine and NorIbogaine, what does that look like and how is that different? And how do we kind of reimagine it? Because in traditional AA, there’s not a lot of talk about trauma, there’s not a lot of talk about these underlying reasons. It’s just you’re an addict. That’s it. Give yourself to higher power, and just fix it all. But it’s not really dealing with the meaning you made of what happened to you, and the trauma that happened to you when you were younger, that drove these addicted behaviors.

Dr. Deborah Mash:
I think pharmaceutical industry has shied away from developing medications for the treatment of addiction because precisely because there’s so much comorbidity in this cohort. These patients find their way to drugs and alcohol, maladaptive behaviors, for a variety of reasons. It’s not a one fit for anybody.
If you look at the epidemiology, I mean straight away you know that women don’t get addicted. We’re somehow protected biologically. Maybe we walk around with more dopamine because of estrogen. I think we do actually. I think are-

Dr. Mark Hyman:
Women don’t get addicted?

Dr. Deborah Mash:
Yeah, no, they’re less likely to get addicted. However, when women become addicts, oh my goodness, they’re sitter than men. So the comorbidity, I worked with a brilliant psychiatrist who was our clinical director, Dr. Frank Ervin trained my mentor at Harvard and Harvard psychiatrist, UCLA, McGill University. So when I started Saint Kitts, we needed to clinically phenotype our people, and I went to Frank. I had been doing research in Saint Kitts with alcohol drinking monkeys down there. That’s a whole nother chapter.

Dr. Mark Hyman:
Whoa.

Dr. Deborah Mash:
Dr. Ervin, Biological, Psychiatrist, Skeptic. He died a few years ago and I miss him so very, very much. But anyway, Dr. Ervin, the first round of patients who went through Saint Kitts, he came to me, his glasses went down on his nose and he looked at me and he said, “Well, Deborah, it blocks opioid withdrawals,” and then I had Dr. Ervin engaged in this.
We spent a lot of time actually doing all the classic psych assessments to understand who was there. What we learned in our small cohort, was that in the opioid dependent group, about 50% of were major depressive disorder, 50. So I think opiates, a lot of people will find their way to opiates, maybe start using them recreationally, or as you pointed out, legitimate pain patients who continue to take opiates.
Somebody like me, I hate opiates. Opiates for me are dysphoric. I go in, if I have a minor surgical procedure and I get prescribed opiates, I don’t take them. I don’t like them. They feel horrible. I feel horrible. I don’t like them. I don’t need them.
Other people. You know can imagine the mommy who’s cesarean section, the doctor, post C-section, gives an opiate, and 90 days later she’s still asking for opiates. That’s our girl. She’s now escalated. So she’s probably medicating, self-medicating, something else going on there. Depression I think is primary for opiates.
For cocaine, we had a lot of comorbidity. We saw comorbidity with Attention Deficit Disorder, down to also Bipolar Disorder, you’re not surprised by that, and the third group was family history positive for alcohol. So cocaine and alcohol go together, this was my Cocaethylene research. What I’m trying to say is, there’s an underlying neurochemical setting that’s going on in the brain, and people are attracted to different classes of substances, be it alcohol, cocaine, and or nicotine, or opiates, that you can kind of separate them out.
So you got to understand what’s the underlying thing. In terms of the work, the seminal work of [inaudible 00:43:04] and others, yeah, there’s a lot of trauma. There’s a lot of sexual abuse in women, we saw that, and men too. Childhood sexual abuse; amazing, stunning, crazy.
I was away from the therapeutic group. I stayed away from that. I allowed the clinicians, I’m not one, I’m a pharmacologist, clinicians worked with patients. But when I went in on a research way and started to read charts, I couldn’t believe what I was reading there. So that’s a huge driver of maladaptive behaviors. We know this.

Dr. Mark Hyman:
I mean I think for sure all the trauma plays a role. I think dealing with that in the post sort of treatment, acute treatment with Ibogaine or any other sort of addiction disruptor, seems really important. And so the therapy associated with it, and I was sort of talking to a guy named Jeff George who’s the chairman of MAP, the Multidisciplinary Association for Psychedelic Studies.
He was talking about the goal they have of getting FDA approval for MDMA assisted therapy. So it’s not just the drug itself, but it’s combined with a whole therapeutic approach, that allows you to deal with the underlying issues that caused the problem in the first place. So it seems like it’s not an either or, but it’s a both and.

Dr. Deborah Mash:
I think that’s right. The other idea that I have in the back of my mind, is when people would first go into rehab, get clean, get sober, and go into rehab, there wasn’t a lot of time or energy to work on trauma. The only thing you could work on was, “How am I going to not go out and get high?” So I can see a world where you can use Ibogaine as an addiction interrupter, and then get down to the what’s underneath there. What is the clinical phenotype? What are the underlying issues?
Is it intractable depression and you’re self-medicating that? Okay, well now you’ve just taken Ibogaine, you’re washing out your NorIbogaine, and maybe your depression will start to come back. And maybe over weeks to months, you’re going to start to feel a wearing off effect of the Ibogaine. Now would you be a good candidate perhaps for Ketamine series? Maybe.
How about you’re a good match to psilocybin therapy? Maybe you are. So what is driving? Is it a dopamine mediated depression or is it a serotonin mediated depression? And here’s where the biomarkers are going to come in and the clinical phenotyping, to allow us to better understand what’s driving the disease of addiction. What’s driving the disease of addiction. Same thing with trauma. Take you’re now got detoxified people. They’re not craving drugs or alcohol. Can you then have them work with the MAPS protocol to start to heal the underlying traumas, and move people out of that state?
So that’s why I’m so excited. And the young generation, the next generation of psychiatrists and therapists will have these tools. How wonderful is that? I will share with your listeners, my father died at 56, alcohol use disorder. He was brilliant.
He was funny, brilliant, spiritual, well-read man, self-taught in many ways. But he had a horrible trauma in his life, and he experienced a major PTSD event and the loss of the life of his brother. In some ways, he blamed himself. I think he did. I was a child so I didn’t really know what was going on with my father’s mental health. But he white knuckled sobriety, he did everything he could to not drink.
I mean he fought it, but stress and whatnot would get him. But when he drank alcohol, it was not good. And ultimately… myocardium of his heart and he died. He died of a broken heart, but he broke his heart completely. I saw him suffer, and he’s a great motivation for me to keep working on this.

Dr. Mark Hyman:
So true. Let me ask you about something that you talked about, which I think is a really interesting concept called psychoplastogens, which turn on increased connections in the brain, enhancing our plasticity, call synaptic plasticity, which means the ability of the brain to make new connections, to learn, to change, to grow, to heal, to repair. Can you talk more about this?
Because it seems to be that many of these compounds that come from nature, whether it’s psilocybin or 5-MeO of the toad, or whether it’s ayahuasca or peyote or San Pedro cactus or Ibogaine from the Iboga tree, they all seem to have this kind of property. Can you talk more about it? What we know about it? What it means? What the implications are for medicine?

Dr. Deborah Mash:
This to me is one of the most exciting areas of this. Maybe it is the most exciting area of psychedelic medicine research going forward, because we have more neurons and neural connections in our brain than there are stars in the milky way galaxy. Think about that. And they turn over.
We’re constantly building and remodeling the brain. I’m the former Director and Founder of the University of Miami Brain Endowment Bank, one of the largest postmortem collections of human brains that anybody had in the world. I went around asking people to please donate their brain for medical research. Actually I did a lot of my own medical research was, as I mentioned, in the field of Alzheimer’s disease and from a neurodegenerative disorders, and then moved into neuropsychiatry.
So I actually looked at how drugs and alcohol affected the human brain. And we know that it hijacks the DNA. It turns on a lot of second messenger systems. It remodels the brain. There’s actual remodeling of the brain. You’re over-wiring certain circuits in the brain that are part of this intractable cycle of misuse of drugs or alcohol. That’s what happens. And so here now-

Dr. Mark Hyman:
On the negative sense, these toxic compounds actually damage the brain and create disconnection. Whereas these other plant compounds create re-connection.

Dr. Deborah Mash:
Yes. So they help heal the brain. And that’s just to me is so incredibly exciting. The other thing is that most of the classical psychedelics turn on serotonin growth factors. So what we call Brain-Derived Growth Neurotrophic Factor, BDNF. brain-derived growth factor is unique in its box, because it turns on dopamine growth factors. Real derived neurotrophic factor. So that makes perfectly good sense because we know that all roads, everything that people will abuse, they’re abusing it to get the dopamine buzz.
So if you’re low dopamine and you go out and you have that first vodka martini, that cigarette, that line of cocaine, smoke a little heroin, chase the dragon, you’re going to get this huge dopamine. So if you’re low dopamine, and then you take a drug, which gets you high, it gets you high because it turns on dopamine. What if Ibogaine is turning on the plasticity modulator, GDNF, to help normalize dopamine in the synapse?
And this is seminal research that it was advanced out of the Gall Institute by a scientist by the name of [inaudible 00:51:41], and her group did some of the original work on this. This is very, very exciting because again, these molecules are turning on synaptic plasticity.

Dr. Mark Hyman:
This is huge. So what you’re saying, just in English, for people listening, is that sort of typical psychedelics increase serotonin by activating various growth factors that increase serotonin in the brain, and the function of serotonin and the receptors and so forth. And that can help with depression and mood and many things we see with the traditional psychedelics like mushrooms or psilocybin, MDMA and so forth.
What you’re saying with Ibogaine and Iboga is that it actually affects the dopamine system, which is what we need to focus, pay attention, be alert, what we want to stimulate for pleasure. It’s really the pleasure place in the brain.

Dr. Deborah Mash:
Drive motivation and affect, or what I like to say, drug, sex and rock and roll.

Dr. Mark Hyman:
Exactly, why we have coffee in the morning is it increases adrenaline and dopamine. So that’s amazing. It just occurs to me that maybe it has wider applications because you take disease like Parkinson’s disease that are dopamine deficiency problems, could this be effective in Parkinson’s, or other uses besides just addiction medicine?

Dr. Deborah Mash:
Well people have tried to bump GDNF, Glial-Derived Neurotrophic Factor in the brain for a treatment of Parkinson’s disease. But it’s very hard to give exogenous growth factors, and get them into the brain. So the fact that these psychedelic molecules turn these things on, is just crazy good. It’s just wonderful science.

Dr. Mark Hyman:
I have a question I’m asking you, which you may not have an answer to, which is always on the top of my mind, which is, how does it know? How do these plants that know what to do with our biology, in other words, how do the compounds in these plants bind certain receptors, activate different pathways? It just doesn’t seem to make sense because we’re humans, they’re plants. What do they have to do with one another? How does it work? Did we evolve with these compounds to help regulate our biology?
I talk a lot about food as medicine and I do see that these compounds are not sort of nice to have. They’re kind of have to have compounds if we want to stay healthy. Whether it’s the anti-inflammatories in food, the antioxidants in food, the phytochemicals that help regulate all our longevity switches. And I just finished writing a book on longevity, and it’s just fascinating to look at these phytochemicals and how our bodies use these compounds from plants, not just for psychological purposes but for maintaining all of our biological systems. From mitochondria to our microbiome, to our immune system, to our detoxification systems, our hormonal regulation. All of this controlled in part by these plant compounds.
So what’s your kind of thinking about how these work? Because these compounds have been used in cultures for thousands of years. Somehow we figured it out, and humans have been using this as sort of spiritual doorways in cultures, for thousands of years, and suddenly we’re sort of figuring out that they have these other properties that may be medically useful. So how did that work? How does it know?

Dr. Deborah Mash:
Plant teachers. I started the discussion with you about alkaloids, that mother nature gives us addicting alkaloids and Ibogaine is Mother Nature’s antidote to addiction. So it makes sense to me. We definitely, throughout human evolution, our brains changed and our liver, and our cytochromes that detoxify things that we eat, evolved and adapted, there’s no doubt about it.
So there is this effect on the neurochemistry and signaling pathways in our brain that have evolved over the course of human evolution. There’s no doubt about it. As our brain expanded and we developed language and all these things, and the written word, that the food in our environment and the things we’re exposed to in the environment, whether teas or tinctures or plant medicines that were known and lost to us, had real effects and beneficial effects.
So I look at this with an open mind and recognize and I too, I’m a true believer in food is medicine. There’s no doubt. I mean there’s no doubt about this. You feel better when you eat right. Hello?

Dr. Mark Hyman:
And the science is there to back it up. Which it’s quite amazing. It’s sort of funny. I think about the sort of anthropocentric hubris, our conceit as humans, that we’re separate from the natural world, that we’re independent from it, that we don’t really need it. That we can live in these concrete boxes and cities. And the truth is that we know we can eat astronaut food and be fine, and live on Mars and be disconnected from the world.
We are biological organisms whether we like it or not, we’re part of nature and we are intimately connected with nature in these incredible ways that are so mysterious to me. I think Einstein said it really well. He said, “I’m not interested in the spectrum of this or that element. I’m interested in the thoughts of God, the rest are details.” So what are the thoughts of God? What is the mind of God? And this is what we’re talking about, is how does this, the orchestration of these molecules and our molecules all work together, to create healing, repair, rejuvenation, end of suffering?
I mean it’s kind of like a existential sort of festival in a sense, to think about all these things where we get to…

Dr. Deborah Mash:
I’m going to use that. I think I’m kind of an overachiever and I lived my life full catastrophic for a lot of years, and tried to control everything. Adult child of an alcoholic, so I fit that mold. But I woke up one day and had the epiphany in my own head, which was, “All knowledge exists in the mind of God and you don’t know this Deborah, so relax.”
This renaissance, this existential festival of knowledge that couldn’t come in a more important time for us, as part of the human family. We really need to learn from the great religions, and from the [inaudible 00:58:42] and plant teachers and wisdom. We need to call in this wisdom.

Dr. Mark Hyman:
That’s really true. I was once in the jungle in Peru, and I met this guy who was an ayahuasca, who was administering ayahuasca, and for those who don’t know, it’s a combination of plants, one of which might kill you if you took it alone. But together they seem to have this beneficial effect. I said, “How did you figure this out? Did a bunch of people die?” He says, “No, no, no. The plants told us.” I’m like, “What? You talked to the plants?” He’s like, “Yeah, the plants told us.”
I’m like, it’s just a realm of knowing and knowledge that we don’t really accept or are familiar with in the west, but it really is what these ancient cultures have. I always wondered how we sort survived all these years because there’s so much nasty stuff around if we eat we’re going to die. So how did we even survive? Somehow we figured it out.
I want to sort of pivot a little bit to talk about, people who might be listening, and wondering about getting treatment. One of the challenges that I’ve come to understand around Ibogaine, it’s not like psilocybin or LSD, where there’s very little lethality. These are very safe compounds, very high doses. They’re becoming called LD50 in medicine, which is a Lethal Dose 50. That seems to be not so much of an issue with these other compounds, but with Ibogaine and Iboga, it seems to be tricky, and that there’s a real cardiac risk in these compounds.
And administered in therapeutic settings like in Costa Rica or Mexico where they’re used in clinics for addiction; they hook people up to an IV, they put them on echocardiogram, they give them oxygen, they watch them with medical supervision. Can you talk about this sort of aspect of it and how we navigate it, and how dangerous is it and is the NorIbogaine also risky or is it just the regular Ibogaine at hallucinogenic doses?

Dr. Deborah Mash:
Ibogaine has been administered to desperate people in unsafe settings and there have been deaths. Your listeners need to know this and understand this. It’s something that I’ve spoken about with a very loud voice, and some people get angry with me about this, but the facts are the facts. Nobody who wants to have a chance to break out of the pattern of maladaptive use of drugs or alcohol, deserves to be given Ibogaine by someone who doesn’t know what they’re doing.
There are unfortunately, unethical individuals and it really is a buyer beware kind of situation. People buy Ibogaine on the internet. Families will send me emails and say, “Dr. Mash, I have just bought some Ibogaine on the internet,” and I’m like, “Oh hell no. No you did not, and do not give that to your child, or your son, or your daughter, or husband. No. You can’t do that. You need to be under medical supervision by a qualified Clinician. You need a doctor who knows what he or she is doing. End of story.”
Having said that, when we started in Saint Kitts, we had no idea of any of this. Okay. We had no idea about what the benefits to risk were for Ibogaine. What the therapeutic-free plasma, the safe plasma concentration was, in humans. And Howard Lotsof had been giving gram quantities of Ibogaine, which is ridiculous. I mean that’s a lot of Ibogaine. And so people look back at some of those early publications and think, “Well I can take that.” No you can’t. No you cannot. You should not, and you don’t.
So what we did in Saint Kitts, and I even think about it now, I look back on our database and our results. Our clinicians, our doctors there, administered Ibogaine to 277 people. Most were opiate dependent, but there were also cocaine. Some were out alcohol or poly drug dependent.
We did not have any deaths in Saint Kitts, but everybody was hooked up to with their own telemetry the whole time. We prepared them to take the Ibogaine, we did full medical evaluations. Everybody had an EKG before they went in, and some people had halter monitors or other cardiac testing, to ensure that they were cardiovascularly fit to take Ibogaine. Because Ibogaine does have an off target effect on the heart. Just like methadone. Methadone causes what we know to be QT prolongation. So the refractory period of the heart changes.
That’s a dangerous thing happen. You don’t want that because when that refractory period changes, if there’s any disease in the heart, then you have the risk of having a lethal arrhythmia.

Dr. Mark Hyman:
So that’s only people with preexisting heart disease is what you’re saying?

Dr. Deborah Mash:
We believe that. Also, as you well know, magnesium deficiency, many people abusing drugs and alcohol, they’re not nutritionally fit. So you got to do their labs, but even when you do their labs and you measure these things, you don’t know what their magnesium and calcium stores are in the heart.
So you need to get people ready for Ibogaine. You need them to be ready and you need to have them a good medical clearance, and you have to have clinicians, doctors who know how to run, to manage an event, in the event that you see an adverse effect of the drug.

Dr. Mark Hyman:
Yeah, and those are manageable if they have them.

Dr. Deborah Mash:
They’re manageable, doctor. They’re manageable if they have them, yes.

Dr. Mark Hyman:
So you’re saying in a well supervised clinic that’s run by physicians who are knowledgeable about how to manage these events, that it’s a very safe treatment?

Dr. Deborah Mash:
That, I have written that. We’ve published on that. I’ve lectured on this and I’ve spoken about it. Today, as we’re running our clinical trial, we are currently doing that safety. Right now, that’s what we’re focused on, is defining the safety window. So as you said, psilocybin is extremely safe. It’s hard to get in trouble with psilocybin. It’s a huge therapeutic to toxic window, huge.
For Ibogaine, it’s more narrow, so we need to define it. We need to define it and we need to know. That’s the concern with Ibogaine.

Dr. Mark Hyman:
Yeah. So you’re doing the hero’s work, which is actually the drug research, the hard clinical trials, proving the safety, the efficacy, the dosing, trying to get it approved by the FDA, so it can be widely adopted. But that could take years still. It’s an arduous, slow process. And now there’s more funding for this research, there’s more interest in it. You’ve been doing this for decades in the dark wilderness, but now the light is coming. That’s good news for everybody.
Yet still, we’re facing this juggernaut of addiction, not just opiate addiction, but all sorts of addiction; alcoholism, food addiction, work addiction, gambling addiction, cocaine. I mean just all the substances, nicotine. It seems as though people hearing this, might be thinking, “Well I don’t want to wait. I know there’s clinics in Mexico or Costa Rica, or who knows where.” Should I go and should I do it? What would you say to them?
I’m sure you’ve been asked this question, and probably as a scientist, you can’t really advise that they do it, but there just seems like a desperate situation where we have a cure or a treatment, but it’s not approved and yet it works.

Dr. Deborah Mash:
That is an important question, and you raise an important concern for people who are desperate, have loved ones and want to know where do I send a loved one to get Ibogaine? I will tell you, I will share that one of my family members, I had to send for an Ibogaine treatment, and I sent them to a place in Mexico with a doctor who trained with us in Saint Kitts.
So when I had loved one, we didn’t have a clinic anymore in Saint Kitts, and here was someone in my family, a family member who needed a detoxification. I got that phone call and said, “You have to detox this person in our family,” and I was like, “What?” So I picked up the phone and I knew where to go, and I called someone, and the doctor was wonderful and they took care of my loved one.
She had a safe Ibogaine treatment and she’s doing very well, and she has child coming in. Very excited about all of this stuff. It’s difficult. Families need to ask the question. I haven’t gone down and vetted all these different places. There are Ibogaine clinics popping up everywhere. Speak to the doctor who’s going to be there. Make sure that you get the right cardiac test. Speak to your clinician in the US. Tell him or her what you’re thinking about doing. Get the information; read online. People can send me emails. They do or they find me, they call me all the time and I’ll discuss it with you.
I feel that that’s a responsibility that we have. I think there are some places that are better than others. I won’t endorse any of them on this call right now, but please, ask the right questions and make sure that you know that what is being administered is in fact, Ibogaine, because I think people take stuff that they’re not sure even what it is. And make sure that you’re with a clinician. Make sure you have a doctor who’s [inaudible 01:08:35].

Dr. Mark Hyman:
Well, I appreciate that, and I think people will be interested to sort of hear that this is a treatment available and maybe it’s worth exploring. I know you can’t answer this because you don’t have a crystal ball, but given you’re so deep in the weeds on the research and the FDA approval process, what’s your best guess in where we’re going to end up with a FDA approved treatment that includes, NorIbogaine or Ibogaine?

Dr. Deborah Mash:
I think about this every day, because I wake up with this thought in my mind-

Dr. Mark Hyman:
I know you do.

Dr. Deborah Mash:
It’s all consuming for me. A little bit going to be the luck of the draw. So right now, we’re doing the dose escalation safety arm, and I have assembled stellar world-class cardiologist, electric cardiologists. So this is the big testing and it’s an expensive study and we’re doing it, and we’re going to get the answers that the regulatory agency needs to know.
Once we get the answers and we’ve got exposure response, and we know that Ibogaine can be administered safely, and what we think we’re seeing is a little benign transient QT prolongation. Methadone is a QT prolonging drug. I’ll just throw that out there for the listeners. So drugs that cause QT prolongation have been approved by the FDA and other regulatory agencies. They are in use. Doctors know this and they’re aware of drug interactions and whatnot.
As we discussed with that information, then we move into what is called a proof of concept study. Now if, or I’m going to say when, we demonstrate what we’ve already seen in open label research, and published by other groups, separate from the work that I’ve done with my colleagues, other people who’ve done the same kinds of things and have publications in peer reviewed medical journals, when we demonstrate the efficacy endpoint, then we have an opportunity, working again with the FDA and other regulatory agencies, to get what Compass Pharmaceutical has for psilocybin; breakthrough designation.
With that, then the question’s going to be the safety database. What’s going to be the size of the safety database in phase three? Is it going to be 500 people, 600 people, 1,000 people? What are the regulators going to ask us to see? I think, given the magnitude of the problem, the trillions and trillions of dollars that are being spent, the lack of other molecules that are entering the pipeline, that the regulatory agencies will absolutely foster this research-

Dr. Mark Hyman:
I think that pharmaceutical company, that Purdue Pharmaceuticals that was responsible for a lot of the epidemic, and who’ve had to pay billions of dollars in fines, that those billions should go to funding this kind of research.

Dr. Deborah Mash:
I do too.

Dr. Mark Hyman:
I feel like the tobacco companies had to pay money for pending research.

Dr. Deborah Mash:
Absolutely. I think, again, I can’t work fast enough. Personally as a person, I can’t work fast enough on this, and I regret that we don’t go faster, but we’re doing it, and we’re here now, and with the support of a tie, and the investors at a tie, we have the funds available to do this research, to do it the right way. This is really, as you said, this is a landmark study.

Dr. Mark Hyman:
It’s so exciting what you’re doing, Deborah. I mean, I think the work you’ve put in over the last 25 years is clearly paying off, there’s going to be millions if not billions of people that benefit from this directly and indirectly, I think. Hopefully, you get the Nobel Prize for this. That’s my goal. So you get recognized for this work, because it’s so important and it’s such a pernicious problem.
It is one of the most hopeful podcasts that I’ve had, because it’s lays out a roadmap for people who are suffering with addiction that has been pathologized and is often just a result of trauma, and not given really adequate treatments, and not given adequate thinking. About what causes it or how to deal with it. It’s due.
I’m so grateful for you and your work and I think if people want to learn more, they can certainly learn more at DemeRx.com, D-E-M-R-X. That’s the company that’s trying to get this licensed and approved. There’s a clinicaltrials.gov, you can look at the study protocol that’s being used. This is real hardcore science. This is not some crazy fringe thing. Thank you for being dedicated and doing this work for so many decades.

Dr. Deborah Mash:
Thank you for engaging me in this discussion and congratulations to you, Doctor, and to all your listeners, for staying well and staying healthy. Thank you for the good that you do.

Dr. Mark Hyman:
Thank you, and everybody listening, if you love this podcast, please share with your friends and family on social media. We’d love to hear from you, maybe share how you struggled and found a way out of addiction, maybe using some of these strategies. Subscribe wherever you get your podcast, and we’ll see you next week on The Doctor’s Farmacy.

Outro:
Hi everyone. I hope you enjoyed this week’s episode. Just a reminder that this podcast is for educational purposes only. This podcast is not a substitute for professional care by a doctor or other qualified medical professional.
This podcast is provided on the understanding that it does not constitute medical or other professional advice or services. If you’re looking for help in your journey, seek out a qualified medical practitioner. If you’re looking for a functional medicine practitioner, you can visit ifm.org and search their Find A Practitioner database.
It’s important that you have someone in your corner who’s trained, who’s a licensed healthcare practitioner, and can help you make changes, especially when it comes to your health.

If you are looking for personalized medical support, we highly recommend contacting Dr. Hyman’s UltraWellness Center in Lenox, Massachusetts today.

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