OAS Endorses Fast-Track Psilocybin Research

OAS Endorses Fast-Track Psilocybin Research

FOR IMMEDIATE RELEASE May 25, 2021 – Ponte Vedra, Florida

Once A Soldier Endorses a Warp Speed Option for Psilocybin Research To Save Veteran Lives

Psilocybin drugs are the rising starts when it comes to killing PTSD in post-9/11 Veterans

In recent days, we have modified our website to include the three major psilocybin treatment options researched today. MDMA, ketamine and magic mushrooms have separated themselves as superior to big-pharma anti-depressant medications. They have shown the unique ability to rewire the brain and destroy a Veteran’s PTSD. Marijuana to a lesser extend provides mental relief from PTSD, but psilocybin has that extra break-though into the subconscious. That’s where the real healing, and magic, takes place. For examples of what it’s like to meet your demons and win during a trip, check this out.

“There is a mounting body of evidence to support our view. And this research is coming from highly-reputable institutions in the US, such as the psilocybin research coming from Johns Hopkins.  We are losing the war on PTSD. PTSD is what kills our Veterans. All forms of micro-dosing these mind-altering drugs shows greater promise than the current schedule of anti-depressants offered by the Veterans’ Administration. We fast-tracked a vaccine for COVID-19, and rightly so. It’s time for that sense of urgency to motivate more help for Veterans with PTSD.” says Dave Barbush, CEO of Once A Soldier.

Indeed, earlier this year, all of the major Veteran Service Organizations (VSOs) in the nation expressed their support, as well.

The best scenario for a successful psilocybin treatment plan includes a clinical setting, a trained staff, and a low cost. The best part of the data to date has been that the relief comes fast and is near permanent. Veterans themselves have weighed in on their feelings about it. They like the outcome. Their PTSD is gone. They may not like the process, but they don’t like being dulled by their anti-depressants either.

Mr. Barbush continued. “Our motivation for fast-tracking research and a parallel training of staff to be “trip buddies” comes from hearing the suicide stories from Veterans families. The horror inflicted upon the Veteran during war is passed down to the family in the years before the suicide. The suicide itself also enables the disorder to continue to grow.

Furthermore, our position includes a robust go-to market strategy that educates all levels of soldiers and family about PTSD treatments, screenings and practical advice on life insurance and post-suicide options.”

“Let’s face it, we are losing the war on Veteran suicide at this time. The more effort we’ve put into it to date, the less we’ve seen it working. In fact, the numbers are rising. And those numbers – the branded 22 a day, were probably low to begin with.”

 

The New Science of Psychedelics Shows Enourmous Potential

The New Science of Psychedelics Shows Enourmous Potential

The History of Psychedelics in the West

Psychedelics, specifically LSD and Magic Mushrooms (Psilocybin), began to impact popular culture in the 1950’s in the United States. LSD was discovered by Albert Hoffman in 1938, but was mainly used as a research chemical. It wasn’t until R. Gordan Wasson published his experience taking magic mushrooms in Mexico in Life magazine in 1957 that news of these compounds reached the general public.

Until the mid-1960’s the mainstream psychiatric community viewed LSD and Psilocybin as miracle drugs. However, once they became more popularized in the public domain they led to the counter culture of the 1960’s which was quite disruptive to the culture of the time. By the end of the decade, the psychiatric and scientific community turned against the compounds. They were legal until that point, but were then outlawed and forced underground. Unfortunately, most of the scientific research of that period died along with the counter-cultural revolution and ensuing prohibition. That research is now being revived and is building upon the studies that were conducted in the 1950’s and 1960’s.

My thanks to all the material in this blog goes to Chris Mukhar who gave his permission for our repost. Read the original post here.

 

urn for ashes

 

Previous Psychedelic Research

Before 1965 there were more than one thousand scientific papers published on psychedelic therapy. There were over 40,000 research subjects involved in the trials. Before the compounds were made illegal, psychedelics were studied for the treatment of alcoholism, depression, OCD, and end of life anxiety. The studies often showed impressive results. However, few of them were well controlled by modern standards (i.e. they were not double blind and placebo controlled).

Perhaps the most exciting scientific research back then was on what can be described as the “betterment of well people”. The most famous of these experiments was the Good Friday Experiment. 20 subjects received a white powder, half of which contained psilocybin and half which contained a placebo, before a Good Friday church service. Most of the subjects reported that the experience had reshaped their lives and work in profound and enduring ways. This research showed incredible promise, but even then, practitioners recognized that if it were to be taken seriously it would have to be carried out with more objectivity and scientific seriousness.

LSD, before its prohibition, was widely believed to be a miracle cure for alcoholism

The National Institute of Mental Health funded psychedelic therapy at Spring Grove in Maryland. Several hundred patients received psychedelic therapy there throughout the 1960’s and 1970’s. With federal support, researchers studied their effects on alcoholics, addicts, cancer patients with end of life anxiety, and others. In many cases the researchers were getting very good results and publishing them in respected peer reviewed journals.

LSD, before its prohibition, was widely believed to be a miracle cure for alcoholism. In fact, one of the cofounders of Alcoholics Anonymous considered using these drugs to induce a “spiritual awakening” that he considered necessary for sobriety.

Bill Richards who worked at Spring Grove recalled, “We thought this was the most incredible frontier in psychiatry. We would talk about how we were going to train the thousands of therapists that would be needed to do this work.”

The Beginnings of Psychedelic Therapy

Al Hubbard, the Johnny Appleseed of LSD, introduced an estimated 6,000 people to LSD in the 1950’s and 1960’s using his seemingly unending supply of LSD from Sandoz Laboratories. He pioneered the process of Psychedelic Therapy. Psychedelic therapy usually consisted of a single high-dose session in comfortable surroundings, perhaps on a couch or in bed, with a therapist or two who are sober and looking on. The therapists try to say very little and let the journey unfold on its own. Eyeshades are often worn and elevator style music is played. The goal was to create the conditions for a spiritual epiphany. 

The goal was to create the conditions for a spiritual epiphany. 

Hubbard established two treatment centers in Canada where he would treat patients to LSD psychedelic therapy. He reported impressive rates of success with alcoholics.

Research published in the early 1960’s by the International Foundation for Advanced Study which used Hubbard’s psychedelic therapy method pointed to some impressive results in a healthy adult population. 78% said the experience had increased their ability to love, 71% showed an increase in self-esteem, and 83% said they had glimpsed a “higher power” or “ultimate reality”. One of the researchers reported that his clients emerged with “sustainable changes in belief, attitudes and behavior”; specifically, they became much more open and less judgmental, rigid and defensive.

Timothy Leary

“In four hours… I learned more about the mind, the brain, and its structures than I did in the preceding fifteen as a diligent psychologist.”

Timothy Leary, a Harvard psychology professor who famously encouraged people to “Turn on, tune in, and drop out” is perhaps the figure most strongly associated with the counter culture of the 1960’s. He is also perhaps most strongly associated with the moral panic surrounding the 1960’s, the backlash towards psychedelics, and the eventual prohibition of this class of drugs.

Leary had his first psychedelic experience using mushrooms in 1960. It was transformative for him. He described his experience as, “In four hours… I learned more about the mind, the brain, and its structures than I did in the preceding fifteen as a diligent psychologist.”

Leary founded the Harvard Psilocybin Project shortly thereafter and his first experiments consisted of administering psilocybin to hundreds of people. To casual observers these experiments looked more like parties, and the researchers themselves reportedly joined in on the fun, taking the substances themselves! … hard to imagine much hard science coming from that environment.

To his credit, Leary is thought to have come up with the idea of “set and setting” being so important to having a good trip.

Leary was convinced that psychedelics had the power to transform society and save humankind. He was determined to bring the experience to everyone. Leary concluded that psychedelics were “too powerful and too controversial” to be researched scientifically and gave up on this entirely. “We are through playing the science game”.

Instead, Leary wanted cultural revolution. “The critical figure for blowing the mind of American society would be four million LSD users and this would happen by 1969.”

To give you a sense of the scale Leary was operating on, it is estimated that 25,000 people attended an event in San Francisco’s Golden Gate Park to trip on free LSD while listening to speakers discuss cultural revolution.

 

The Human Be-In Event at Golden Gate Park. 1

It turns out Leary’s math was pretty close. By 1969 an estimated two million Americans had tried LSD. It had indeed blown America’s mind and the country was in a very different place, culturally, than it was when he started.

Although Timothy Leary is the most well known and notorious figure associated with the counter-culture. Pollan concludes that this would have happened without him as well. Psychedelics were seeping into American culture from many channels.

Prohibition

By the end of 1966 the whole project of science surrounding psychedelics had collapsed. The senate held a hearing about LSD that year. A few months later, almost all of the psychedelic researchers across the United States received a letter from the FDA ordering them to stop their work.

Pollan concludes that what doomed Psychedelics in the 1960’s was an irrational exuberance surrounding the drugs themselves. They were a disruptive technology. Those that had experiences with these drugs concluded that they contained the power to change the world. The researchers studying these drugs concluded that it was wrong to only use these drugs for research and for healing the sick. They could do so much more for the world!

Leary sparked a political revolution partly because he was willing to say what those within the research community thought was true, but didn’t want to speak or write about publicly. It was one thing to use these drugs to treat the ill. It was another thing entirely to treat the sickness within the culture of society itself.

A New Path Forward

The first wave of psychedelic research was careful and methodical and contained a set of protocols and shamanistic rituals that, in effect, regulated their use and broad effects. Leary unleashed an unguided, do-it-yourself approach to psychedelics. Perhaps this was too laissez-faire.

Other cultures have had long and productive histories with psychedelics that we can learn from. These cultures have sets of rituals, rules, or procedures that govern them. They also typically have someone (a shaman) to guide the experience. For American’s the closest thing to this would have been psychedelic therapy, as pioneered by Al Hubbard.

Pollan thinks that these drugs are too transformative to be unleashed on society without anything to govern or contain them. He concludes that without psychedelics there probably would have been a counterculture around the Vietnam War. It just wouldn’t have been as strong of a backlash.

John Hopkins

Research on psychedelics is now being revived and is building upon the studies that were conducted in the 1950’s and 1960’s, but this time with far more rigorous scientific methods.

I think of my life as before and after Psilocybin

Participants in a John Hopkins study on Psilocybin ranked their experience using psychedelic therapy as one of the most meaningful in their lives, ”…comparable to the birth of a first child or death of a parent.”2 A full two-thirds of those in the study ranked the experience among their top five most spiritually significant experiences and one-third ranked it as the most spiritually significant experience of their lives. The participants reported significant increases in “personal well-being, life satisfaction, and positive behavior change.” This study, carried out by Roland Griffiths, was the first rigorously designed, double-blind, placebo-controlled trial to be carried out. On a side note, I actually tried to recreate this study on my own and I must say it was one of the most spiritually significant experiences of my life, profoundly changing my life philosophy and tendency toward altruism.

The John Hopkins team under Roland Griffiths has now been conducting Psychedelic research for 15 years. They have conducted over 300 psilocybin sessions.

Pollan interviewed many of the subjects in the Hopkins study on spiritual experiences. He reports that although most of the subjects had their psilocybin experience 10-15 years earlier, their effects were still deeply felt, for many on a daily basis. One volunteer even relayed, “I think of my life as before and after Psilocybin.”

Research also indicates that psilocybin might be useful in treating addiction. A pilot study achieved an 80% cessation rate, which is unprecedented.

Griffiths also ran a trial using psilocybin to treat anxiety and depression in cancer patients. It reported one of the largest treatment effects ever. The majority of subjects reported that their fear of death had completely disappeared or greatly diminished.

Psychedelics, the Default Mode Network, and the Ego

Researchers discovered, by putting people into MRI machines, that psychedelics affect brain activity by dramatically reducing activity in what has come to be known as the Default Mode Network (DMN).

The Default Mode Network exhibits heightened activity when subjects are doing nothing of substance mentally. This area of the brain is thus called the “Default Mode Network”. This is what is active in our brains when our minds wonder, ruminate, and worry.

Quite a lot is going on when our minds aren’t doing anything in particular.

But quite a lot is going on when our minds aren’t doing “anything in particular”. In fact, the default mode network consumes more energy than other brain states. The default mode is most active when we are doing “metacognitive” tasks such as self-reflection, imagining what it is like to be someone else, moral reasoning, etc.

Electrical signals within some brain areas take precedence over others. The DMN is at the top of the hierarchy, organizing all the other signals. Without the DMN, our brain might not be able to maintain order, causing us to devolve into mental illness.

The default mode network appears to play a key role in mental constructs, the most important of which is our sense of self or ego. Some neuroscientists have even referred to it as the “me network”. Nodes within the default mode network are thought to enable us to tell the story of ourselves, linking our past experiences to our present experience and potential future experiences.

A sense of self is a highlight of human cognitive evolution, however it has its drawbacks. Individual identity creates a sense of separation from others and nature. Most people take their sense of self as an unshakeable given, and Pollan states that he felt this way too until his psychedelic experience made him feel otherwise.

The deactivation of the brain’s default mode network corresponds to the loss of a sense of self. Similar results are achieved by putting experienced meditators into fMRI scanners. The transcendence of self, reported by expert meditators, corresponded to a steep drop off in activity within the default mode network.

It appears that when the activity within the default mode network declines significantly, the ego temporarily vanishes and the usual boundaries we experience between self and other, subject and object, all melt away. This sense of merging into some larger experience is a hallmark of mystical experience.

The mystical experience may be what it feels like when you deactivate the default mode network (ego). This can be achieved through psychedelics and meditation, but also through overwhelming experiences of awe, breath work, sensory deprivation, fasting, etc.

The default mode network doesn’t just exert top-down control over the mind. It also helps regulate what is let into conscious awareness from outside. It operates as what Aldous Huxley would describe as the minds “reducing valve”. Without this regulation of what is let into conscious awareness, our minds might struggle to process the torrent of information being let in – as is the case sometimes during the psychedelic experience.

 

Image from Petri et al, 2014, showing the additional connections made between distinct areas of the brain on psilocybin.

The brain typically takes in as little sensory information as it needs in order to make educated guesses. We are always cutting to the chase and leaping to conclusions, using prior experience as a guide. Our perception of the world is thus not actually reality but an illusion based on data from our past. Normal consciousness feels transparent, but it is less a window of reality and more a product of our imaginations, a controlled hallucination.

The brain has gotten very good at observing and testing reality and developing reliable predictions that optimize the brain for energy efficiency. Uncertainty is the brains biggest challenge and it has been encoded to solve for this uncertainty with the utmost efficiency.

Moving from the science of the default mode network to the theories of the researchers themselves. One of the leading researchers on the DMN, Robin Carhart-Harris, contends that brain disorders such as depression, obsessive compulsion, addiction, and others are not due to disorder within the brain, but too much order. This is when a hyperactive default mode network triggers a repetitive and destructive loop of rumination.  He believes that these compounds can break these patterns of thought by deactivating the default mode networks and restoring the correct amount of order within the brain, providing relief from depression, addiction, etc.

The Ego and Spirituality

Pollan describes his own psychedelic journeys and their relationship to the ego. These journeys helped him understand that there is much more to consciousness than the ego. The dissolution of the ego is a prerequisite to spiritual progress, to transcendence.

The ego is what Huxley referred to when he described the minds “reducing valve” which eliminates much of reality. The ego is a security guard that only lets in a narrow band of reality, “a measly trickle of the kind of consciousness that will help us stay alive.” The ego is really good at the things natural selection values, “getting ahead, being liked or loved, getting fed and getting laid. It keeps everything else at bay from our minds eye.”

A spiritual experience is just what happens when the ego is diminished.

Pollan says that it was only when his ego was quieted by psilocybin that he was able to sense the spirits of the plants in his garden. He knew intellectually that every species around him was alive and interacting with other species, but it wasn’t until his trip that this became “more deeply infused”. This is what he calls a spiritual experience.

Pollan theorizes that a spiritual experience is just what happens when the ego is diminished. Wonders or terrors it normally defends from our awareness manifest themselves. The difference between self and other, which the ego normally keeps up, is diminished when it is not on patrol. This allows us to feel more connected to something greater than ourselves. Whether we call this nature, God or something else hardly matters.

Death and Ego Death

Psychedelics seem to have a unique therapeutic ability to help people deal with their own deaths. Both NYU and John Hopkins researchers gave psychedelics to cancer patients with terminal diagnosis. About 80% of them showed clinically significant reductions in anxiety and depression. Few, if any, psychiatric interventions of any kind have achieved such results. 

Both research experiments found a high correlation between the intensity of the mystical experience and the degree that their depression and anxiety was relieved. As we have seen above, psychedelics deactivate the brain’s default mode network which causes a loss of self or ego. The more the default mode is deactivated, the more intense the mystical experience.

Many people report something called “ego death” when taking a high dose psychedelic. “A high dose psychedelic experience is death practice,” says Katherine MacLean, the former Hopkins psychologist. “You’re losing everything you know to be real, letting go of your ego and your body, and that process can feel like dying.” Pollan continues, “And yet the experience brings the comforting news that there is something on the other side of that death—whether it is the “great plane of consciousness” or one’s ashes underground being taken up by the roots of trees—and some abiding, disembodied intelligence to somehow know it.”

Psilocybin, by temporarily diminishing the ego via the default mode network, seems to open up new realms of psychological possibility. Many experience death and rebirth on their journeys. At first, losing yourself feels scary, but if one can surrender to the experience (as patients are advised to do) positive emotions typically flow through. What seems to come out of the experience for many people is love. Love for specific people, but also love for everyone and everything. Love as the purpose and meaning of life; the ultimate truth. Or, as The Beatles sang, “Love is all you need”.

The true gift of psychedelics is their ability to turn everything in one’s experience into something meaningful.

The true gift of psychedelics, Pollan hypothesizes, is their ability to turn everything in one’s experience into something meaningful. Even for avowed atheists like Pollan and myself, psychedelics can change a world from something like cold chance, to something with incredible meaning and consequence.

To imbue life with a sense of meaning, whether of oneness with nature or universal love or something else, can make one’s own death far easier to contemplate. Religion has typically provided a sense of meaning to people, but why should we rely on religion alone for this sense of meaning?

Addiction

Cigarettes are very addictive, some say it is even harder to quit than heroin. A Hopkins study 3 found that six months after their psychedelic sessions, 80% of the subjects were confirmed via testing to be abstinent. At the one-year mark, 67% had remained abstinent. These types of numbers are nothing short of astonishing. Interestingly, the number one predictor of an individual’s ability to quit smoking was whether or not they had a mystical experience.

Strangely, the insights people bring back from psychedelic journeys are surprisingly boring or plainly obvious. People who trip often experience different dimensions, infinite timeframes, meet strange god-like beings, and have many other out of this world experiences. Yet their epiphanies when they come back to a normal mind state are often mundane, “Love is the purpose of life”, “Eat right and exercise”, or simply “Stop smoking”.

We often, smokers included, know things about ourselves. Smokers know that their habit is unhealthy. Yet, psychedelics seem to help them to know this in a deeper way that carries more weight.

One of the researchers from the study says that addiction is a story that people get stuck in. A story that gets reinforced every time they try to quit and fail. The thoughts ruminate and they get stuck in a rut. “I’m a smoker and I’m powerless to quit” they tell themselves.

Psychedelics seem to help break this thought pattern. Again, by diminishing the ego and the default mode network. It seems to enable smokers and other addicts to take a step back and see their addiction (and the story they have been telling themselves about it), in the larger context of their lives.

The therapist plays a role similar to a traditional shaman

Pollan notes that psychedelics might not work on their own. Numerous people have taken psyschedelics and continued to smoke cigarettes. If a breaking of the addiction is to happen, it is because it is the express purpose of the session, reinforced by the therapist in preparatory sessions and integration sessions afterward. The therapist plays a role similar to a traditional shaman in this regard, setting the stage for a successful trip. It is important to understand that this is psychedelic-assisted psychotherapy, rather than being as simple as taking psychedelics without much forethought or follow-up work.

Using psychedelics to treat addiction is nothing new. Native Americans traditionally used peyote to treat alcoholism and other addictions, and it has been a better treatment for them than anything Westernized medicine has come up with thus far.

given the evidence… it is puzzling why this treatment has been largely overlooked

The initial evidence has in fact been pretty clear, even before prohibition. In 2012, a meta-analysis reviewed the six best, randomized controlled studies from the 1960’s and 1970’s, over 500 patients in total, and found that a single dose of LSD created a clinically “significant beneficial effect on alcohol misuse” for up to six months. The authors of the study conclude, “given the evidence… it is puzzling why this treatment has been largely overlooked.”

Those who work with Alcoholics understand it as a spiritual disorder. Over time they lose their connection to everything but Alcohol. Life loses its meaning and at the end, nothing is more important than the bottle, not even their spouses or their children. Eventually, the worst alcoholics sacrifice everything to their disease. If alcoholism is a dramatic narrowing of perspective, psychedelics, by their very nature, offer a compelling antidote. A way to dramatically open up a person’s perspective of themselves, and their relationship with others and the natural world.

In the same way, psychedelics show promise in helping treat depression. Interviews with depressed patients show some common themes. Depression is often described as a state of disconnection, either from other people, a past self, their own feelings, their own spiritual values or core beliefs, or from nature itself. Depressed people also often describe being in a “mental prison” that they cannot escape, a place where they are stuck in endless circles of rumination. Psychedelics offer an opportunity to reorder a depressed patients mental state, to reconnect them, if only temporarily, to that which they feel disconnected from.

The Ego and Buddhism

Pollan, when summarizing his journey writing the book and taking psychedelics, comes back to the dissolution of the ego as the most important and most therapeutic effect of psychedelics. Although Pollan found little overlap in the metaphors or vocabulary of all the researchers or practitioners he interviewed. Whether they viewed psychedelics though a spiritual, psychoanalytic, or neurological lens, it seems to be the loss of ego or self that is the key driver of the psychedelic experience. The loss of ego is what provides for all of the different experiences people describe: the mystical experience, a mental reboot, a sense of psychic death, the experience of awe, and the re-formation of meaning.

Pollan quotes what numerous guides have told him, “the psychedelic journey may not give you what you want, but it will give you what you need.” He notes that this is true for his journey. He expected a religious experience, and although that wasn’t what he experienced at all, he does describe the journey as a spiritual experience. I can also say that this is true for me. I was hoping for a religious experience, but did not get what I expected. However, it has made me feel a deep connection with all beings, what could be more spiritual than that!

The discovery that the brains of experienced meditators and those on psilocybin look remarkably similar through MRI scans is of interest. Buddhists believe that attachment is at the root of all suffering and that by detaching from our own thoughts, feelings and desires we can escape our own human suffering. Buddhists often describe this process as become detached from our own ego. Both psychedelics and meditation appear to enable us to be with our thoughts and desires without getting caught up in them.

It is incredibly easy to dismiss the psychedelic journey as simply a drug experience, and wave our hands and dismiss it as something that doesn’t matter. But it is important to remember that the experience, the narratives, the images and the insights don’t come from out of nowhere. They come from our own minds, and at the very least they have something to tell us about that.

This is the value of exploring different conscious states. The ability to reflect back on how that compares to the normal state of consciousness, which might no longer look so normal. Normal consciousness, by its nature, must only be a subset of the possible states of consciousness, optimized by evolution for our own survival but not much else.

Pollan states that he can sometimes access the state of psychedelic consciousness through meditation and I have found this to be true as well. Other people have noted this too, Sam Harris and Steve Jobs come to mind. Just because an experience takes place while on a drug doesn’t mean that the experience isn’t real. The experience itself is real and can be one of the most profound a human can have.

Summary

The history of psychedelics, both in other cultures and pre-prohibition western culture, indicates the enormous potential they hold for benefiting people who suffer from all kinds of mental disorders including addiction, depression, and anxiety. They also indicate enormous potential for people with no known disorders, by fostering a spiritual experience and deep connection to nature and other people.

These benefits are thought to be due to the temporary diminishment of the default mode network or ego that is experienced by people on these drugs. Interestingly, experienced meditators show the same mind state as those on psychedelics, indicating that the Buddhists were on to something with their teachings.

Psychedelic research is clearly still in its infancy, but the evidence we do have points in a clear direction. These drugs show enormous potential and we should be massively funding further research on these chemicals.

Pollan thinks that these drugs should be carefully regulated, with access limited to carefully planned psychedelic therapy sessions with a trained shaman or guide. This seems reasonable, but I’m also uncertain that Leary’s approach is completely incorrect. With the right education, set and setting, and intention, people should be able to have similar experiences in their own homes. After all, the psychedelic guide’s purpose is to let the journey unfold on its own and to provide reassurance during difficult moments.

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Latest FDA-Approved PTSD And Depression Treatments

Latest FDA-Approved PTSD And Depression Treatments

A Timeline of New Psychedelic Therapy Options

Prompted by a TV news report about the FDA’s approval of yet another psychedeleic antidepressant, I thought it might be a good idea to group all these breakthroughs together to compare and contrast. 

If you’re out of the loop on this front, let me bring you up to speed quickly. In short, it turns out that the hippies were right: using psychedelic drugs is a mind-blowing experience. Street drugs like LSD, Ecstasy and Super K have been approved by the FDA for use to treat “treament-resistant” patients. These drugs are administered in a clinical setting using micro-doses. Typically, the patient is under supervision for 2 hours after the dosing. There is a treatment pattern and the results are immediate and durable. 

On the downside, they are expensive and not covered by insurance. 

Here’s our recap timeline of the new psychedelic therapy options:

MARCH 5, 2019

Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

Ketamine is approved and labeled by the U.S. Food & Drug Administration (FDA) for both of these uses in the United States. Ketamine was originally developed as an anesthetic and an analgesic or pain reliever.

Prazosin was approved for the treatment of high blood pressure in 1976 but it is now mostly used for the treatment of nightmares in patients with post-traumatic stress disorder, a use that was not originally approved.

AUGUST 2018

The US Food and Drug Administration (FDA) has granted approval to COMPASS Pathways’ planned clinical trial to test psilocybin therapy in patients with treatment-resistant depression.

The phase 2b dose-ranging trial will involve 216 patients across 12-15 research sites in North America and Europe, beginning in the UK later this month. Federal regulatory agencies have already granted approval for such a trial in the UK, Canada, and the Netherlands.

 

AUGUST 8 2006

Ketamine Found to Give Almost Immediate Relief for Severe Depression
Symptoms of depression can be made to disappear in less than two hours with a common anesthetic, not the weeks or months required for onset of relief with traditional antidepressants, according to results of a pilot study.

FEBRUARY 29 2008

FDA Approves Wyeth’s Pristiq
Desvenlafaxine is an antidepressant (serotonin-norepinephrine reuptake inhibitor type-SNRI) used in the treatment of depression.

It works by restoring the balance of natural substances (neurotransmitters such as serotonin and norepinephrine) in the brain. Desvenlafaxine may improve your mood, feelings of well-being, and energy level. Pristiq is a medication licensed for the treatment of depression. By blocking the reuptake of serotonin and norepinephrine in the brain, the drug can help improve symptoms. Pristiq, which is available by prescription only, comes in the form of an extended-release tablet, and is generally taken once daily. Potential side effects include dizziness, insomnia, headaches, and nausea.

DECEMBER 29 1987

FDA Approves Lilly’s Prozac
Prozac is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Prozac affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Prozac is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Prozac is sometimes used together with another medication called olanzapine (Zyprexa) to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Here’s a portion of the FDA’s March 5, 2019 Press Announcement

 

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression.

The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.

The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use. The FDA approved ketamine (Ketalar) in 1970.

 

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