Psychedelics have gained mainstream attention because of media’s reporting on promising research and Michael Pollan’s recent documentary on Netflix, How to Change Your Mind. The promise to reduce symptoms related to mental illness, and an ever-growing list of other conditions, such as neurodegenerative diseases, anorexia, cluster headaches, autism, substance use disorders, and more, is too good for people to ignore.

Many of the studies show promising results, with none more compelling than those using psilocybin with adjunct psychotherapy to reduce psychological and existential distress in those with life-threatening illnesses. For two decades, prestigious universities such as Johns Hopkins, NYU and UCLA have consistently shown that the use of psilocybin-assisted therapy reduces anxiety and depression in participants with advanced-stage cancer. Not only that, but participants also confronted their fear of dying, found meaning in their lives and felt at peace with their death and dying.
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The JHU researchers found that six months after two psilocybin dosing sessions with associated psychotherapy, 79% and 83% of participants significantly reduced depression and anxiety, respectively, and >80% reported increased feelings of well-being. Similarly, in a study conducted at the New York University Langone Medical Center, research showed that eight months following a single psilocybin dose, 83% and 58% of the participants were in remission for depression and anxiety, respectively.  

From these studies and others, participants commonly report a feeling of oneness and a reduction in the fear of dying, the latter considered a correlate for increased anxiety and depression in palliative care patients. JHU published a study August 24, 2022, to compare people who have used psychedelics to people who have experienced near death or similar experiences (NDEs). They surveyed 3,192 participants, 933 of them were non-psychedelics users but had NDEs, the remaining participants had used a variety of psychedelics, including psilocybin and LSD. One similarity between the groups found that 88% of the non-psychedelic users and 89% of the psychedelic users, experienced a reduction in their fear of dying. In general, they also found that the scores on the mystical and near-death experience questionnaires, were significantly higher in the Psychedelic Group than those in the Non-Psychedelic Group.

This leaves those of us wanting to ease the suffering for those at end-of-life in a tremendous quandary. Currently, the only legal recourse to the use of psilocybin is to travel out of country to places such as, the Netherlands, Jamaica or Costa Rica. One psilocybin retreat in Jamaica is the first to offer a specially curated psilocybin exploration with facilitated discussions on the topics of death and dying, as well as experiential training for hospice and palliative care professionals (full disclosure, I am on contract with them). The retreat, developed by an end-of-life doula and led by a psychedelic-trained psychotherapist with 30 years’ experience as a hospice social worker, help attendees and their families explore what a good death means to them.

Beyond that, we can wait until Oregon’s licensed Psilocybin Service Centers become fully operational, sometime in 2023. Or, if you live in Canada with a life-threatening illness and fortunate enough to be accepted into Canada Health’s Special Access Program, you may be prescribed psilocybin.

There is a less glamorous “psychedelic” that is gaining traction for palliative care. Ketamine is technically not even a psychedelic, it’s a dissociative anesthetic. It can be prescribed off-label in many countries including the US, Canada and the UK and shown great promise reducing severe chronic pain and symptoms of anxiety and depression. Although many health care professionals have administered it to patients in the context of emergency care or surgical procedures, it is not yet standard protocol in most palliative care centers where it arguably would be extraordinarily efficacious.

Ketamine has its pros and cons: although rapid acting, reducing severe chronic pain, anxiety and depression, as well as suicidal ideation, it is, relative to other psychedelics, shorter lasting. Board Certified Anesthesiologist, Dr. Steven Reichbach and founder of the Reichbach Center for Ketamine and Cannabis in Sarasota, Florida, administers Ketamine Intravenous Infusions according to the industry’s “gold standard” to extend its efficacy. He administers a series of six infusions over a 2-3 week period of time, followed by “boosters” on an as needed basis. This has the benefit of extending the duration of the therapeutic benefit, both for his chronic pain and mental health patients. The good news, too, is that many patients are referred to him by the local hospice agency with similar outcomes, reducing, not just anxiety, depression and suicidal ideation, but also easing his patients’ fear of dying.

Dr. Michelle Weiner, DO, MPH, is a Pain Management Specialist at Spine Wellness of America in the Miami, Florida area and frequent speaker on the topics of ketamine and psychedelics for palliative care. Her standard protocol is to administer a series of Ketamine Intramuscular Injections (IM) over a period of 3 - 6 weeks, then also offering boosters on an as needed basis. For some patients, she also prescribes lower dose ketamine sublingual lozenges (also called troches) for at-home use. This can effectively maintain a therapeutic benefit, reducing the number of in-clinic injections needed. With the proper preparation, setting and assistance at home some cancer patients may use a 100mg-200mg lozenge to help treat pain and end-of-life distress.

There is an excellent guide published March 2022 by Brain Futures on Psychedelic Medicine detailing the research on multiple psychedelics, including Ketamine. They report on several studies involving palliative care since “studies suggest that those suffering from chronic pain are four times more likely to have depression or anxiety than those who are pain-free.” By reducing chronic pain, the general consensus is that ketamine can greatly mediate anxiety and depression without the potential for opioid abuse. One of the studies Brain Futures reported on showed ketamine’s ability to reduce severe pain experienced by complex regional pain syndrome (CRPS) sufferers. The researchers showed that 76% of patients reported complete pain relief with 54% remaining pain free for more than 3 months.

And, supportive of Ketamine’s ability to reduce chronic pain effectively, one 2021 study found “use of a standardized Ketamine Step Protocol showed a statistically significant reduction in pain and Morphine Equivalent Daily Dose (MEDD) in patients with predominantly neuropathic cancer pain. It also demonstrated a safe and effective method for opioid reduction after commencement of parenteral ketamine.”

Ketamine’s future may even get brighter for palliative care. Yale University received a grant to study ketamine to relieve depression in patients with Parkinson’s and PharmaTher has FDA approval for a Phase II Clinical Trial to study the effects of Ketamine to reduce Levodopa-induced dyskinesia. Stay tuned to both psilocybin and ketamine as clinical trials and real-world studies continue to be compiled.

Christine Caldwell is the former owner of a 250-client home health agency, certified Neuro-Linguistics Programming life coach and Deepak Chopra Meditation and Health Instructor. She is currently enrolled in Psychedelics Today Psychedelics Integration Training Program and is on contract as Manager, End-of-Life Programs, for Diaspora Psychedelic Society, a psilocybin retreat in Jamaica. She also is a self-proclaimed neuroscience and quantum mechanics geek.
 
REFERENCES
1https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367557/
2https://journals.sagepub.com/doi/10.1177/0269881116675512
3https://journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0271926 
4https://www.brainfutures.org/mental-health-treatment/patevidence/
5https://pubmed.ncbi.nlm.nih.gov/15367304/
6https://www.tandfonline.com/doi/abs/10.1080/09699260.2021.1922146
7https://medicine.yale.edu/news-article/michael-j-fox-foundation-grant-will-fund-first-clinical-trial-of-ketamine-to-treat-depression-in-people-with-parkinsons-disease/
8https://clinicaltrials.gov/ct2/show/NCT04912115?term=ketamine&cond=Parkinson+Disease&draw=2&rank=2

The Early Years

​Rick Doblin, Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS), is credited with getting MDMA to the brink of FDA approval. He started MAPS in 1986 with the seemingly impossible goal of bringing mass mental health to the world using psychedelics. He gave it 50 years. With any luck, MAPS will see the legalization of their first psychedelic, MDMA, in 37. But the journey started way back before 1986 and had its roots in Southwest Florida.

At age 18, Rick began studies in 1971 at Sarasota-based New College. As a “child of the 70s”, Rick has acknowledged experimenting with various psychedelics, including LSD. For a young man of 18, it can be overwhelming and for Rick, LSD created an existential crisis, sending him to seek help from the school’s guidance counselor. That counselor was the beginning of several synchronicities as he gave him a book by Stan Grof, Associate Professor in Psychiatry at John Hopkins University, and an early researcher in LSD therapy. Rick became hooked. He wrote to Stan and was amazed when he responded, inviting him to a month-long workshop in California in the Summer of 1972.

That Fall he dropped out of college and didn’t return for 10 years, telling GQ in an article published 10/26/21, “The reason I took 10 years off is because I had done so much LSD and mescaline, in particular, and a little bit of psilocybin mushrooms, that I was really lost.” As fate would have it, just as Rick was set to continue his studies, Stan Grof interceded again. Stan was by now a Scholar-in-Residence at the Esalen Institute. Founded in 1962, Esalen’s goal was to explore human potential through, among other modalities, transpersonal psychology and altered states of consciousness. In the Summer of 1982, Rick won a coveted spot as an Esalen Work Scholar, working for Stan. And, yes, he dropped out of college again.

Enter MDMA (aka Ecstasy and Molly): during the 70s and early 80s, MDMA remained legal and millions of people took Ecstasy while clubbing. The Drug Enforcement Agency (DEA) was determined to put a halt to the loophole that allowed it to remain legal. Rick had lived through the criminalization of LSD and was determined to get in the front of the curve to stop the DEA from criminalizing MDMA. Through 1984, he fought the good fight, traveling to Washington, DC several times to try and stop them.

He ended up losing Round One to the DEA as they did criminalize MDMA in 1985 so he concluded that effecting policy change would be the only route to legalization. He set about to learn what he needed and returned to New College, finally graduating in 1987, 16 years after he started. He followed that with a PhD in Public Policy at Harvard’s Kennedy School of Government, completing his doctorate in 2001.

Along the way, he had a life-altering dream about the holocaust that told him he must do what he can to stop humankind from destroying itself and Rick believed psychedelics were the means. Although it was clear that he was blessed to have been born with the intelligence and determination to see him through the long, journey ahead, it was the dream that drove him with the fear that he must not fail. He launched MAPS in 1986 and worked hard from 1986 to 1990 when the DEA finally allowed research using psychedelics. There was cause for celebration as MAPS could finally begin clinical research using MDMA.

The FDA Years
It typically takes 15 years for a drug to receive FDA approval. Imagine the fight then to seek approval for an illegal drug. In the end, the process added more than 20 years to the timeline. One early roadblock is that, even though the DEA had finally allowed psychedelic research in 1990, it was not until 1999 that MAPS was able to propose a study using MDMA-assisted psychotherapy to treat PTSD. Barrier after barrier had been put up only to be knocked down by Rick and his equally determined colleagues at MAPS.

Yet another five years would pass before MAPS would start their Phase II Clinical Trial. Then it took 13 more years, during which time MAPS and several other research institutions conducted their own trials, before the FDA finally awarded MDMA a Breakthrough Therapy Designation. The Designation meant the FDA had agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD. So, there they were in 2017, more than 30 years since MAPS founding, clearing the hurdle to what may be considered the toughest part yet as they knew many companies spend years getting to this same point only to fail in the make-or-break Phase III Clinical Trials.

Finally, fast forward to May 2021 when the first of two required Phase III Clinical Trials demonstrated significant rates of eliminating PTSD symptoms in 90 subjects. After 2 months, 67% of participants receiving MDMA-assisted psychotherapy exhibited zero PTSD symptoms as compared to the 32% that had received a placebo with psychotherapy. The second Phase III Clinical Trial is now underway and is set to be wrapped up at the end of 2022. Although not guaranteed, there is every expectation that this second trial will also yield significant results and the FDA will approve MDMA in 2023, 37 years after MAPS was launched.

Why MDMA
I know I wondered why MAPS chose MDMA out of all the psychedelics and why they focused on PTSD. The simple reason was that Rick had an experience with a friend who suffered from PTSD who had been helped by a combination of MDMA and talk therapy. Standard anti-depressant medications help PTSD sufferers only 20%-30% of the time which leaves millions of people suffering. Turns out, of all the psychedelics, MDMA is the sweet spot for opening those parts of the brain that can heal trauma. Although all psychedelics increase a sense of oneness and positive mood, MDMA, unlike the others, does not cause ego dissolution, increasing activity in the prefrontal cortex, that part of the brain that controls rational thought. At the same time, MDMA also quiets the amygdala, our fear center. This allows a “window of opportunity” to open, and a trained psychotherapist can guide the PTSD sufferer to confront and work through their trauma.
The Cycle Continues

Looking to 2023
FDA approval may be thought of as finishing a marathon, but only one with several more to go. After federal approval, each state must reschedule MDMA for use in a medical setting. Then there is the uphill battle to legalize psychedelic-assisted psychotherapy in the rest of the world. Additionally, MAPS’ mission has not changed. They still seek to bring mass mental health to the world and will not stop until all psychedelics are accessible and affordable for all. Rick clearly understands the multi-generational effort required to bring MAPS’ vision to reality saying, “Psychedelic-assisted psychotherapy research is more urgent than ever. This next generation’s passion and ability to be successful holds great promise, as does the growing disillusionment with the disastrous Drug War.”

This story does circle back to Southwest Florida. Another New College of Florida grad, Alexandra Mars, is also determined to take up the mantle and fight for legalization. As a child, Alex suffered from Crohn’s Disease and after years of failed treatments, turned to plant medicines for relief. As a result, her life’s mission is to educate people on the power they can elicit on collective and individual healing. But as fierce as Alex is about the need to build global consensus on the power of plant medicines, she is just as fierce about protecting our planet. Her senior thesis at New College of Florida was on the influence of psychedelics on human connectedness and their relationship to nature and the environment. Rick, committed as ever to walking the talk, was right there serving as one of her mentors.

If Alexandra is proved right, psychedelics will greatly impact our ability to protect the environment to ensure the survival of our planet. Joseph Campbell, the foremost scholar on myths, bemoaned the death of myths and the rituals associated with them as the source for humankind’s disconnectedness and inevitable destruction of our world. Way back in the early 1980s, Campbell had said that environmental activism may be the only way we reconnect and save our very existence. Hence, the cycle continues: from Joe, to Rick, to Alex. Rock on!

Sources:
https://journals.sagepub.com/doi/abs/10.1177/0269881119845793?journalCode=jopahttps://journals.sagepub.com/doi/abs/10.1177/0269881119845793?journalCode=jopahttps://journals.sagepub.com/doi/abs/10.1177/0269881119845793?journalCode=jopa
https://www.nature.com/articles/s41591-021-01336-3
https://www.nytimes.com/2021/05/03/health/mdma-approval.html?pk_campaign=2021-MAPP1-NYT&pk_kwd=button-article
https://soundcloud.com/voices-of-esalen/psychedelic-integration-pt-3-rick-doblin-on-maps-mdma-esalen-and-ptsd
https://www.gq.com/story/rick-doblin-interview-where-the-psychedelic-revolution-is-headed?fbclid=IwAR2cuIHixor4myElJlNh9xWowMeOKBJWW0Zvaq4lyxhZDo6GohVDb7DtwYY