Globes Israel Business News: A First Look at a Surprising New Study to be Held in Israel: The Party Drug That Will Treat PTSD Patients

Summary: Globes Israel Business News speaks to MAPS Founder Rick Doblin, Ph.D., about MAPS-sponsored clinical trials of MDMA-assisted psychotherapy taking place in Israel, Doblin’s role within Israel’s medical cannabis industry, and the MAPS-sponsored clinical trial of medical cannabis for PTSD in the United States.

Disclaimer (U.S. FDA-Regulated Trial of Cannabis for PTSD): This study was supported by funding from the Colorado Department of Public Health and Environment (CDPHE). The content and opinions are those of the grantee/authors and do not represent the official views of CDPHE.

Originally appearing here.

In the coming months, the first clinical trial will begin in Israel: treatment of post-traumatic stress disorder blocks using MDMA. The trial, which will take place at the Sheba Medical Center and the Be’er Ya’akov Mental Health Center, will take place, perhaps surprisingly, as part of a protocol by the Food and Drug Administration. It will be conducted in Israel and around the world by MAPS, which develops drugs based on psychedelic substances and is defined as a public benefit company. In other words, its profits only finance its continued development.

“The trial is not MDMA, but psychological therapy under MDMA guidance,” says Rick Doblin, CEO and founder of the company, who has a degree in psychology and a PhD in public policy and is currently one of the most active MDMA activists in the United States. “It is considered on the street as a drug of euphoria and love, but MDMA-driven psychotherapy is not fun, it’s a painful but significant treatment.”

Doblin is pleased with the cooperation he has achieved in Israel. “My visit here was tremendous,” he says. “I met with about 30 therapists who want to cooperate, including Dr. Edna Foa, one of the leading psychotherapists in post-traumatic stress disorder. She wants to test a combination of MDMA in therapy. We also had a successful meeting with the Ministry of Health, which supports both our Phase III trial in Israel and MDMA for another 50 patients as a compassionate treatment without a control group.”

Not all is known about the activity of MDMA in the brain. Like many street vendors and parties, the actual use of decades precedes the understanding of their activities, and street wisdom about the effect of the drug mixes with myths and wishes. According to Doblin, someone who uses Ecstasy at a party does not necessarily get a real MDMA. Sometimes these are other substances and sometimes the doses are low, and the placebo effect is no less significant in the mythology of the drug than its chemical effect.

Only in recent years did the material begin to be seriously studied. To date, it has been tested for about 700 people, most of them healthy volunteers. MDMA, which is associated with mood and dyspepsia, is associated with brain release of dopamine (identified with information processing and memory, positive reinforcement, absence associated with depression), serotonin (identified with good mood, but also with psychedelic effects). The substance has been defined by neuroscientists as a hybrid between a stimulant that stimulates activity in the brain and a psychedelic drug that causes distortion of reality.

In an experiment published in the journal Biological Psychiatry, signed by many researchers, MDMA was given to 25 volunteers. Five subjects reported feeling nothing, and 20 subjects reported an unusually good mood effect. Some of them reported feelings of self-acceptance, peace of mind, blurring of ego and blurring boundaries between the self and the environment. Some also said that the experience had “mystical” qualities.

Brain scans of the subjects showed decreased brain activity in the amygdala region, identified with alertness and fear (but also with positive emotions), in areas that respond to external sensory input, and in the hippocampus region, which is related to memory processing.

As a party drug, MDMA is recognized as a substance that creates a positive social experience. Those who use it will often recommend it as anti-misanthropy and improve relationships and sexual experiences in relationships.

One of the interesting studies that examined this was actually done with octopuses. We already know that these are very intelligent animals with extraordinary planning abilities in the animal world and are able to deceive humans, which means they can probably take into account the state of consciousness of the person facing them. But social life is extraordinary – there are no octopuses. Except for reproduction, they are almost never close together.

The nervous system of the octopus is very different from ours, but in their distributed nervous system there is one receptor that is identical to the receptor found in the human brain and is usually associated with serotonin. MDMA can also be attached to it.

The researchers, Dr. Eric Edsinger of the University of Chicago and Prof. Gull Dolan of Johns Hopkins University, dipped the octopus into the MDMA bath for 10 minutes and then examined whether they spent more time in society. In which they were found in the reproductive cycle, as well as “slow, deliberate, uncharacteristic but target-oriented movements” in all octopus receiving MDMA.

The conclusion of the study was that social mechanisms hidden deep in the octopus’s brain may also arise in the use of MDMA. The drug works on a brain area that is very basic and evolutionary (an area that appears in different species and has hardly changed), to the point of being able to evoke it even in octopus, which is usually extinguished.

Based on the “street wisdom” of drug users and following an examination of the effect of the drug on the brain, MAPS decided to direct the study first to patients in post-trauma.

“The phenomenon of post-trauma is characterized by decreased activity in the hippocampus, the region that stores new memories in the brain and connects new memories to the old ones, and increases the activity of the amygdala region in the brain, which is associated with feelings of fear and arousal.”

“People who suffer from PTSD experience the traumatic event at any moment as if it is happening now, and there are changes in the memory processes that cause mechanisms that are related to forgetfulness to not function normally and the event is not forgotten.

“Our goal in using this substance in psychological therapy is to raise levels of trust and empathy, to make patients able to shift fear aside for enough time to reduce avoidance and to cope with difficult memory.”

According to the evidence that Doblin presents on the company’s website, it seems that the success of the treatment depends, among other things, on the therapist and the patients’ expectations. One of the patients, Karen Diamond of Colorado, a sign language translator and producer of sexually assaulted art shows, said: “I did not feel afraid and I did not feel out of control. I did not even feel like I was in Hey, although I had metaphorical visions, That came to my mind and had a reality a little stronger than usually have imagination or idea.

“The big advantage was that I managed to take basic principles that I learned in all the previous psychological treatments I underwent, and for the first time to assimilate them into my consciousness in a way that feels permanent … I already knew everything on the cognitive level, but now I know and really believe in it. Psychological in one day.

“Since the treatment I have not been woken up every morning by the day I’m coming in. I do not wake up in the middle of the night sweating with a quick heartbeat, I do not try to control every detail of my life and that of my relatives, When an unexpected event arrives, I can deal with it. “

John Seoul, an athlete who suffered from PTSD following a life-threatening illness, he wrote: “caregivers Seoul gradually proposed to deal with” that matter “.” We talked about the most terrible things but I felt something beyond comfort, beauty emerges from feeling sadness, I felt grateful and love unusual magnitude. Glacier of sorrow, but, disappointment and fear fell away and began to wash the other way. “

According to MAPS, all patients in the experiment so far, as well as some 600 healthy volunteers participated in MDMA controlled trials to date, no damage had been medication, except for transient effects of anxiety or paranoia, only a few cases, when giving the drug.

Professor Marilyn Yustis, who for many years was a senior at the National Institute for Drug Abuse Research in the United States (NIDA), cautions her enthusiasm and warns against uncontrolled use: “It’s a drug that can kill,” she told “Globes.” Of young women who dismiss him less than men. It also turns out to be a drug that suppresses its own decomposition, meaning that if you take a dose and then another dose, the result will be more than two doses. Most deaths are from high doses, although there are cases of low-dose death, especially in first-use women. Sometimes death is caused by being overheated. Sometimes you drink a lot in order not to get warm and then you get water poisoning, which means diluting the electrolytes in the body.

“We do not know much about the long-term effects of the substance,” said the doctor, who wrote many studies in the field and was forced to pull them all out when it turned out that he had given other material.

As for the positive effects of the drug, such as love, empathy and closeness, according to Yustis, some claim that they are long-term, but they have seen the glider in the Institute, usually 48 hours after taking the drug. “I’m waiting for further research later,” she says.

“MDMA was developed by the German Mark Company in 1912,” says Doblin. “They gave the medicine to live, but animals can not say, ‘Oh, I feel love for other animals and a sense of inner perfection,’ so they did not know what the real effects of the product were.”

In 1970, the material was rediscovered by Alexander Schulgin, a leading psychologist. Shulgin, a chemist and pharmacist, synthesized and tried hundreds of psychoactive substances and extensively documented his experiences. He discovered an efficient and simple method of synthesizing MDMA, and was therefore considered the domain’s father. He died at age 88 of liver cancer. Shulgin also gave the material its name, anagram of “Adam”, in memory of the good days of Adam and Eve in the Garden of Eden.

“In the 1980s, MDMA became a party drug, and I realized that the trend was going towards criminality, so I set up MAPS then to protect the medical and useful use of the substance.

“At the age of 18 I decided to focus my life on Psychedelia, and grew up in the United States, to a Jewish family that mostly lives in Israel. My father was a doctor, I grew up in an environment that felt very safe: I was an American white man, the eldest, and the chosen Jewish people. But I was very afraid of the Holocaust. I was thinking a great deal about the processes in the human brain and about irrationality. I was thinking about these thoughts when the Cold War developed. When the Vietnam War came, I decided to identify myself as a pacifist, but in the end no one called me. I ignored the war and she ignored me. In the meantime, I studied public policy at Harvard, and I have a doctorate in public policy in the field of drugs. Because my way was blocked by politicians, I understood that I had to learn politics, and so I did. “

In the 1980s, Doblin underwent a formative experience as a therapist. “My grandmother was depressed and I could not legally give her MDMA, so what I did was take MDMA myself and go out with her,” she told me, “I did everything I wanted to do and now I want to die.” The MDMA helped me tell her, What you wanted – how wonderful. “At that event, she revealed to me an affair she had before she met my grandfather, and no one knew about it, and the regret over the separation undermined her at her older age.

What is the connection between Jews and Psychedelia?
Doblin says he founded MAPS as a public utility company to avoid suspicion. “I know that when companies engage in medical drugs, or even in medical products, the question is whether they are over-marketing to make money if they deny the problems in the product to sell more if they do not develop better products so as not to destroy the existing business. I’m pre-positioned where my wealth does not depend on how many drugs I sell, my goal is to bring the best product to the market, and profitability is only the means. “

The company was founded in 1986 and has raised $70 million to date, of which about $27 million is earmarked for the new research. Dolbin’s vision is for clinicians to treat cannabis, MDMA, ketamine, psilocybin (the active ingredient in hallucinogenic mushrooms) and possibly LSD.

$5 million was donated by soap maker Dr. Bronnerz and 5 million by rich Jews, including Facebook’s first investors and the Pritzker family, a wealthy Jewish family engaged in philanthropy and operating mainly under the radar.

The company has many Jewish donors. Is there a Jewish connection to Psychedelic post-trauma?

“When people suffer from trauma, they do not think rationally, they are afraid and afraid and have no mood to make peace or worry about weaker people.” Historically, Jews are more likely to support pacifism and weak groups, and they also believe that a person’s real property is what is in his brain We have not been the ‘bad Jews’, like the Sackler family that pushed the opiates into the market and caused an addiction epidemic in the United States. “

Doblin has many rights in the medical cannabis industry in Israel. When he realized that Cannabis was closer to medialization than MDMA, he decided to promote it first. “About a decade ago, when this field just started in Israel, and it was not yet possible to sell the material, but only to offer it for free, I helped Better Cannabis, a pioneer in the field, recruit one of its first donors.

The same donor was the family of soap makers Dr Bronner’s, whose founder was Emil Brunner, an American Jew of German origin. “In Germany, his family was involved in the manufacture of soap, but he immigrated to the United States in the 1930s after intense arguments with his father on everything from modern methods of soap production to Zionism or just interpersonal differences.”

“After his entire family perished in the Holocaust, he suffered from post-traumatic stress disorder and tried to take it in positive directions to spread love messages among people, so that these horrific events would not return. Of love. He himself was hospitalized in a psychiatric institution following his unusual messages, but escaped after a while. In the 1960s these products became the fashion of the day among the hippies. In the 1990s, after Emile passed away, the company passed into the hands of his sons, including David, who was an arbiter of cannabis. That’s how the donation came. “

Better, who received the donation and became one of the pioneers of cannabis in Israel and around the world, was founded by Yochai Golan Gild, the son of Galia Golan Gild (a professor of political science, a former CIA employee and today a leftist activist and feminist). Golan-Gild grew up in the United States and was one of the first growers of legal cannabis in California, before organizing nature parties in Israel, but he could not see it as an economic blessing.

Doblin and Golan-Gild met at the Burning Man Festival. Dorbine offered to help bring medical marijuana to Israel as long as the company was completely legal. “Now that the export of medical cannabis from Israel has been confirmed, my dream is that it will be possible to import Betar’s cannabis from Israel to the United States,” he says, adding that Doblin is also a partner of Better Cannabis in the United States.

“We hope that as we progress to marijuana better, we will be able to achieve better results.” The substance that is approved today for research in the United States is moldy, dry, low levels of active substances. Because they tried to criticize what was apparently bad about him, they did not worry about what was good about him. “

Cannabis is also used to treat post-trauma. “Treatment with MDMA is a long-term treatment of the root cause of the disease,” says Dolbin. “The treatment of cannabis helps to cope with the symptoms, such as a bad night’s sleep, and in every disease there is deep treatment and treatment of the symptoms, and in this field we want to promote both.”

“We are now completing a three-year project aimed at learning about the effect of four different cannabis compounds (in terms of THC to CBD ratio) in 76 people with PTSD, and we received $ 2.1 million from the state of Colorado for it.