Category Archives: Psychedelics

Tahlia Harrison has been bombarded with questions about psychedelics. A practicing therapist, Harrison recently graduated from the bioethics and science policy program at Duke University, where I teach and served as her masters thesis supervisor. Her patients are increasingly interested in experimental regimens that use drugs like LSD, psilocybin, and MDMA to treat post-traumatic stress disorder and other forms of trauma.

Harrisons patients are hardly alone. Since 1970, psychedelics have been considered Schedule I drugs in the U.S., with the feds maintaining that they have no accepted medical use. But in recent years, the government has softened its stance and, accompanied by no small amount of hype, psychedelic-assisted therapies are now being tested in dozens of clinical trials. These studies can present substantial health and safety risks to the patient, and a number of trials have been attached to allegations of sexual abuse. To better understand how these risks are communicated to prospective study participants, earlier this year Harrison set out to collect consent forms used in more than three dozen psychedelic-assisted therapy trials listed on the federally run website clinicaltrials.gov.

To her disappointment, she was able to download consent forms from just five of the trials that met her criteria. And despite directly contacting the organizations running the studies, only one responded to her queries.

Since the long parade of ethics scandals that plagued biomedical research during the 20th century from Nazi doctors experiments, to the Tuskegee Syphilis Study, to a Brooklyn hospital study that injected patients with live cancer cells informed consent has been a hallmark of research on human beings. It enshrines the idea that we cant experiment on people without first informing them of the risks and benefits and, obviously, getting their permission. The consent forms used in clinical trials, as dense and lawyerly as they might be, are meant to answer questions like: What is involved in the study? How long will it take? Will I get paid? What happens if it goes sideways?

But in many cases, few people outside of the researchers, participants, and the institutional review boards charged with approving a study ever see the language used in a trials consent form. Recently, there has been a push toward greater transparency, under the rationale that broadly publicizing the forms researchers use to communicate the risks and benefits of clinical trials will improve accountability, boost public trust in research, and inform the development of future consent forms. But what Harrisons experience, and what my own look at clinicaltrials.gov seem to show, is that the science community isnt pushing nearly hard enough.

A major win for informed consent transparency came in 2018, when federal officials updated the so-called Common Rule a regulation that covers human subjects research funded by 20 U.S. agencies, including the Department of Health and Human Services, under which the National Institutes of Health falls. Effective January 21, 2019, the rule change requires federally funded clinical trials to publish an approved consent form on a public federal website; the form is to be posted after the close of patient recruitment but no later than 60 days after participants last required study visit. Researchers are given an option to upload the form either to clinicaltrials.gov or to a designated folder at the federal website regulations.gov.

Late last year researchers at Brigham and Womens Hospital and the National Library of Medicine found that while the number of posted consent forms is indeed rising, it is hardly keeping pace with the Common Rules requirements. The authors found, for example, that fewer than 18 percent of NIH-funded studies had posted forms.

Late last year researchers at Brigham and Womens Hospital and the National Library of Medicine found that while the number of posted consent forms is indeed rising, it is hardly keeping pace with the Common Rules requirements.

In September, I conducted my own search of clinicaltrials.gov and found that only 283 of the 1,112 federally funded interventional studies listed on the site as having started after January 21, 2019 and finished before January 21, 2022 had uploaded consent forms. Some of the studies had yet to upload any results at all, but even when I limited my search to those that had an idea suggested to me by Geisinger research ethicist Michelle Meyer little more than half had posted consent forms. (I also searched all of the more than 427,000 studies listed at clinicaltrials.gov including past, ongoing, and upcoming studies in the U.S. and elsewhere that arent subject to the Common Rule and found that consent forms had been shared by only 1.3 percent of them.) Meanwhile, the designated folder at regulations.gov,the alternative site where studies may deposit consent forms to satisfy the Common Rule, contained just 44 consent forms posted during the three-year window.

To be fair, some people have sounded alarms about publicly sharing consent forms. In practice, they note, researchers often use the forms less as a way to inform participants and more as a means to mitigate institutional liability. (You cant sue us here at Big Academic Medical Center it was all in the consent form!) At least one group of health care attorneys argued that posting requirements could prompt researchers to write even more stilted, legalistic forms aimed at shielding themselves from lawsuits. The same group also fretted that a rule requiring the public posting of a consent form might confuse participants and the public, because a clinical trial will sometimes use different versions of the form for different participants at different sites, and the consent form might get updated throughout the recruitment process. Who would decide which version to post, and how? Elsewhere, there were concerns that a public posting requirement would stifle innovation, for example, by keeping clinical investigators from exploring novel approaches to consent such as interactive video Q&As.

Public posting of consent form language is a low-risk, low-burden act that could give motivated prospective participants a chance to see what they might be signing up for well ahead of time and gives all stakeholders an opportunity to flag problems.

I was and remain unmoved by these complaints. Publicizing consent forms will make them worse? Wait, what? And sharing them with everyone rather than with just the people you want to participate will necessarily increase liability risks? If so, thats a problem with American jurisprudence and not a justification for opacity. As for the potential confusion over multiple versions of a consent form, in an appropriate consent process prospective participants should always be given the most updated version of the consent form, and an opportunity to ask questions. And one provision of the revised Common Rule mandates that multisite trials use a single institutional review board, which should help standardize consent forms across the different sites. We now have some evidence that this is indeed happening, although some local institutions have been reluctant to cede control.

With respect to video consent and other innovative approaches, the updated Common Rule says nothing about them other than references to electronic format, and its not clear why novel consent processes shouldnt be done transparently: Why not post a link to your consent video on clinicaltrials.gov for all the world to see?

As someone who has served on an institutional review board, read thousands of pages of mind-numbing consent forms, and participated in research as a human subject over the past 15 years, I think that the Common Rule more or less gets it right. Public posting of consent form language is a low-risk, low-burden act that could give motivated prospective participants a chance to see what they might be signing up for well ahead of time and gives all stakeholders an opportunity to flag problems. It could lead to more equitable, safer, better research. Or maybe not. But the only way we can know is by doing the experiment.

For patients like Harrisons, who seek risky but potentially life-saving experimental therapies, the stakes couldnt be higher. Some contend and, for what its worth, I agree that the fervor of the current psychedelic hype cycle is driven more by a messianic push for legitimacy than by an unbiased search for truth. But what if MDMA really works? What if psychedelic-assisted therapy, delivered in a safe environment, can bring relief and healing to people suffering from PTSD and other traumas? Dont we want as many folks as possible considering all of the risks and benefits, the promises and disclaimers? Couldnt controversial psychedelic-assisted therapy studies have benefited from a few more eyes on their consent forms?

We can read millions of scientific papers, court documents, real estate listings, restaurant menus, drug prices, and movie reviews all with just a few keystrokes.

So why not consent forms?

Misha Angrist is associate professor at Duke Universitys Social Science Research Institute and a senior fellow in its Initiative for Science & Society.

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Let's Bring the Informed Consent Process Out of the Shadows - Undark Magazine

Your story Shelter recounts the adventures of an American man on a business trip to Israel who gets caught up in an unexpected drama. What drew you to Cohen as a character?

In the story, Cohen, middle-aged, believes himself to be in stasis, but stumbles unwittingly into a moment of great dynamism. As a younger person, I used to think of middle age the way many coastal people driving across the country think of the Midwest: as a huge, vaguely menacing, but mostly boring expanse where one contemplates how far one has come and how far one still has left to go. I didnt understand what was meant by amidlife crisis,beyond the disappointment of no longer being what I still happily was: fabulously young. For that reason, I mostly avoided middle-aged characters in my writing, preferring the young or the old, whose crises I somehow imagined myself more equipped to fathom. But, now that Ive arrived at middle age myself, I realize that I couldnt have been more mistaken. I guess its always the case that we believe whatever age we are at to be the most interesting. But what a radical, rich, utterly riveting time of life it is! I look around at my friendsadmittedly a lively, searching bunchand Im just amazed by the variety of dramatic positions and problems and possibilities everyone is facing. Theres something very moving to me about all the late revelations that are not yet so late that they can be ignored, about the deep settling into oneself that makes settling for what doesnt fit no longer acceptable. To be honest, Ive come to feel a great warmth for middle age, and more and more I find myself wanting to be there in my writing.

The climactic scene of the story takes place in amamak, a reinforced safe room, in Tel Aviv. Why did you choose that space for Cohens moment of action and the birth of a baby?

Being in Tel Aviv while rockets are exploded overhead by anti-missiles is a surreal experience. I mean, war itself must always seem surreal. But, in Tel Aviv, what often fascinates me is the way that, a moment after the missiles have been destroyed and the sirens have fallen silent, the whole city snaps back to whatever it was doing right before the emergency began. The conversation that had stopped midsentence resumes, the waiters and waitresses once more sail smoothly between tables, and everything continues as if nothing had happened. This deft restoration of normalcy is itself surreal, the result of a collective refusal to allow a certain aspect of realitythe one where fear and horror liveto take root and unfurl. The shelter, then, where one goes to wait for the danger to pass is, in a sense, the only place where that realitythe reality of death, of the fact that people want to kill and are killedis acknowledged. So it interested me, by contrast, to set a birth there. And not just any birth but one attended to by a man who is returning from his own private excursion into surrealism, courtesy of psychedelics, and descending back into a reality he would rather not face.

Why did you choose to have Cohen be on psilocybin in this scene?

For the reason above. And Id add that in this scene hes actually coming down from his trip. Like sex, psychedelics are easier done than written about. Its nearly impossible to convincingly describe the specific experiences one has had on psilocybin because an aspect of sobriety is skepticism, and skepticism is completely annulled by psychedelics. Everything one feels and experiencespositive or negative, beautiful or scaryis wholly felt and believed. Doubt requires distance, and there is no distance in a psychedelic experience, no stepping back or away. But then one has to come down, and that return, I suppose, is what I was interested in writing aboutthat middle zone where one has not yet lost access to that state of being and belief, even as one is recalled to a reality that cant fully host it. When Cohen is confronted with, as they say, the miracle of life, he hasnt yet lost his sense of wonder, his belief in his own goodness; he hasnt yet been reminded of his own failures, so he can half believe himself to be a part of the miracle.

Cohen feels that he has played a momentous role in the delivery of Navas babyand, of course, physically, he has. But, since we see everything in the story through his eyes, its difficult to know how Nava feels about what happened. Do you have an idea?

Of what Nava feels for Cohen and his part? In the grand scheme of her own experience, probably not all that much. Giving birthtalk about a totalizing experience. Talk about be here now! I dont know of another sober experience more self-absorbing than labor. Everyone elsethe nurses, the doctor, even the fathersort of fades away offstage, as far as I recall, and you are alone inside this enormous event. Which is ironic, because the moment you give birth you cease to be the main protagonist of your own life. Your child takes up that role, and you fall back to play all the other parts. So the labor of delivery is your last chance to be the star of your own life, at least for a very long while.

The story is written in the third person, but, as discussed, its more or less Cohens internal monologue. What appeals to you about writing from that perspective?

Theres a line in the story: between Cohen and Cohen something else had slipped in, courtesy of the perspective of middle age: a hand span of ironic distance. I think its that hand span of distancenot too much and not too littlethat also attracts me to a close third person. The photographer Diane Arbus once described how everyone has a need to look one way but is always seen in another. This space between what we want people to know about us and what we cant help people knowing about us she called the gap between intention and effect. And its that gap that a close third-person perspective bridges, allowing for irony and a touch of humor.

Shelter reminds me a little of your story Zusya on the Roofanother narrative in which a man at a turning point in his life is confronted with the so-called miracle of birth and deeply affected by it. Why do you think this is such a rich subject for you? What do Brodman, the protagonist of Zusya, and Cohen have in common?

A writer friend of mine described the character of Cohen as one of my less ruined men. Its true that theres a certain kind of stymied character that interests me, though not so much for his failure or his ruination as for the moment when he suddenly sees, shining up ahead, a way out. It allows for a story that both looks back at a life and looks forward into the future, a view that can be heady, even breathtaking. Whether the escape or the solution is real or notwhether he actually transcends what he feels bound or oppressed byinterests me less than the encounter with possibility. The chance for redemption: isnt that finally the great subject of all literature?

Read the rest here:

Nicole Krauss on Death, Birth, and Middle Age - The New Yorker

The Story

A psychedelic could treat depression.

Yesterday, a newly-published study found that ketamine was effective at reducing symptoms of suicidal thoughts, depression, and anxiety. During a year-long period involving over 400 patients, about three-quarters saw their moods improve. And nearly 40% say they were symptom-free after 10 infusions of ketamine.

Thats because ketamine (aka Special K) is used by some to get a psychedelic high. But its also used medically and legally as an FDA-approved anesthetic. And it's increasingly used as an off-label mental health treatment. ketamine is also proven effective in treating psychiatric conditions like eating disorders. Now, the real-world data from the study is giving experts a better understanding of the drug. And it couldnt come at a better time

Last month, the new 988 Suicide and Crisis Lifeline saw a 45% uptick in calls, chats, and text messages compared to the year before. And it comes as Americans have seen reported increases in rates of anxiety and depression since the pandemic began. If youre struggling with symptoms of depression, youre not alone.

While ketamine could prove to be a game changer for mental health, researchers say more trials are needed to assess the drug's full effects. But reminder: psychedelics are still illegal in most of the US.

PS: If you or someone you know is struggling with suicidal thoughts, call the National Suicide Prevention Lifeline at 988.

The Justice Dept. Since last week, the DOJ has reportedly subpoenaed around 40 of former President Trump's associates. Its considered a significant escalation in the DOJs investigation into the Jan 6 Capitol riot and other attempts to overturn the 2020 election. The subpoenas were sent to everyone from low-level aides to senior advisers. The DOJ also seized two cell phones that were apparently in connection with the fake elector plan. Aka the alleged plot to overturn the 2020 election by submitting fake electors in seven swing states like Georgia, Pennsylvania, and Arizona...the ones President Biden won by thiiiis much. It comes as the Jan 6 House committee is nearing the end of its investigation. They could decide whether to request testimony from Trump and former VP Mike Pence as early as today.

...Oh and in other Trump news, the DOJ's signaling it's open to one of Trump's picks for a special master. Judge Raymond Dearie could serve as the third party person to review the docs taken from Mar-a-Lago last month. But a federal judge overseeing the case needs to sign off.

Nurses. Yesterday, about 15,000 nurses in Minnesota walked out on their jobs across several hospitals to protest understaffing and work conditions. Its reportedly the largest protest in US history involving private sector nurses. They claim some units operate without a lead nurse on duty. And that inexperienced nurses are saddled with tasks more senior figures usually handle. Now, the protest is expected to last three days. The nurses are asking to have a say in staffing plans and pay bumps over 30%. And the president of the Minnesota Nurses Association says meeting their wage demands will help resolve retention problems. But hospitals say they cant afford the wage demands and say the nurses have refused to meet at the mediating table.

Johnson & Johnson. Over the weekend, the company reached a settlement in Australia over allegedly selling defective pelvic mesh. The material is often used in women who are suffering from urinary incontinence (which can be common after childbirth and menopause) or to help hold pelvic organs in place. J&Js been in trouble for this mesh before. Earlier this year, a California court ordered them to pay $302 million for not being upfront about the risks. But thousands of women filed complaints against J&J, alleging the companys pelvic mesh led to chronic pain, urinary problems, and painful sex. Now, Johnson & Johnson will be paying $300 million in two class action suits.

The Emmy Awards.

iMessage is letting people hit the edit button.

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Daily Skimm: Psychedelics, The DOJ, and iMessages - theSkimm

Ali has suffered from depression since she was 12 years old. Now a trained paediatric nurse living in Bristol, she has taken antidepressants and other medication for most of her adult life. In her late twenties, following the death of a close friend, Alis depression spiralled and she was unable to continue working. Trapped at home, the drugs she was being prescribed were causing her to gain weight, have recurring nightmares and sleep paralysis.

I was in a desperate place, Ali recalls. I had tried all sorts of therapies and medications. I was on really high doses. I think my mental health team didnt know what else to do with me. In 2019, Ali joined a trial being run by David Nutt, professor of neuropsychopharmacology at Imperial College, and Robin Carhart-Harris, head of Imperials Centre for Psychedelic Research, testing the impact of psilocybin the main active ingredient in magic mushrooms alongside psychotherapy, in 59 people with moderate to severe depression.

During her first psilocybin trip Ali experienced euphoria and a kind of spaciousness that was very different from the insular, crushing feelings of depression. She recalls wandering outside her own body through a cathedral-like building. In her second dosing session she travelled through different landscapes and memories. During one stage she was reunited with her deceased friend. I floated as a river with her for what felt like hours. It was a way of saying goodbye because I didnt get to do that, she recalls.

Not only were these psychedelic experiences life-affirming for Ali, but they also liberated her from myopic ways of thinking: I felt like myself for the first time in a long time. I wasnt completely free from my depression, but I was able to start seeing the good in life again and enjoy things, she explains. I promised myself that I was going to try to live, and to enjoy life.

During the trial, Prof Nutt and his colleagues found the psilocybin, when used in conjunction with therapy, produced rapid antidepressant effects. It was as effective as escitalopram (used to treat depression) and scored better in two key areas: participants reported a better sense of wellbeing and 58 per cent were considered in remission six weeks after treatment, compared with 28 per cent in the escitalopram group.

Prof Nutt has been researching psilocybin for around 20 years, but interest in psychedelic treatments is growing. Research from Kings College, London, published in January 2022, evaluated the safety of psilocybin as part of therapy in the largest randomised controlled trial of psilocybin in the UK to date; documentaries like Michael Pollans How to Change Your Mind are reaching new audiences on Netflix; and this month Europes first commercial facility for psychedelic drug trials is opening in central London.

Situated in an Edwardian townhouse off Harley Street, the clinic is a bland place with revolutionary aims. Apart from its calming dcor and opaque curtains there are few indications that it is a site where participants will experience mind-bending drug trips. But while the new era of psychedelic research might have its roots in the hippie communes of the 60s, and the turn on, tune in, drop out mantras of US psychologist Timothy Leary and his LSD acolytes, todays practitioners are rigorous, data-driven scientists.

Later this month, a team of around a dozen scientists, psychotherapists and clinicians will step into this newly renovated facility to launch Clerkenwell Health, a commercial contract research organisation (CRO) founded to facilitate clinical trials to test psychedelics for drug developers.

If you listen to the psychedelic purists of the 60s, the only setting is a hut in the middle of the Amazonian jungle, but thats been a challenge to reproduce in Central London, Emilio Arbe, Clerkenwells chief medical officer, tells i.

Since the ultimate aim is to bring these treatments to mainstream psychiatry, weve moved away from anything too exotic.

The first trials here, scheduled to begin in October, will test the effects of psilocybin, along with psychotherapy, on around 60 cancer patients struggling with terminal diagnoses. After three sessions of psychotherapy, half will receive the drug and half a placebo. The trial is being conducted for the Toronto-based biotech company, Psyence.

Using these drugs for psychiatric therapy isnt new. English psychiatrist Humphrey Osmond famous for trying to cure alcoholism with LSD coined the term psychedelic in 1956 in a letter to writer and mescaline user Aldous Huxley. The same year British psychiatrist Ronald Sandison was working in the worlds first purpose-built LSD unit at Powick psychiatric hospital near Malvern in Worcestershire, using the substance to help treat depression and schizophrenia.

In the late 60s and early 70s countries including the US and UK moved to make the use of LSD and psilocybin illegal. In the UK, the Misuse of Drugs Act (1973) also restricted medicinal use. Both remain Class A, schedule 1 listed drugs, meaning they are illegal and officially classified as having no medical use. The ruling has severely restricted, but not prohibited, clinical research into the ways psychedelics can influence the mind.

Clerkenwell is not the first organisation in the UK to experiment with mind-altering substances, but it is the first commercially funded venture to conduct clinical trials on its premises.

Having a specialist facility for psychedelic drug trials is essential to help bring new treatments to market, says co-founder and chief scientific officer Henry Fisher. A drug development company wants to run a clinical trial as quickly, efficiently, and safely as possible, he says. Its not just about giving someone a drug. The therapy is a vital and fundamental component to the intervention, as is the setting in which its delivered.

Like Ali, Ian Roullier, 45, has also taken psilocybin as part of a previous clinical pilot run by Imperial College London in 2015. After suffering for years from anxiety and depression, Roullier hit rock bottom in 2014. As a journalist he had worked himself to the point of exhaustion and was feeling burnt out. He took various types of antidepressants to try to find some respite from his low moods but they only made him feel numb and lifeless. After hearing about the trial at Imperial he enlisted, desperate to see if psilocybin-assisted therapy could help.

Roullier describes the ordeal as a visceral and challenging exercise. During his hallucinatory trip he engaged with feelings and emotions he had been avoiding for years. It was a Wizard of Oz moment, Roullier recalls. That doesnt mean that everything was rosy and beautiful, but my anxiety and depression had lifted. I approached situations openly, the self doubt, and self recrimination in my head had faded away.

Psilocybins potential to be a therapeutic enabler seems to stem from its ability to break down the rigidity of depressive thinking. Brain scans show that it increases connectedness between different parts of the brain. In particular, the compound stimulates a serotonin receptor in the cortex linked to neuroplasticity. Nutt hopes that it can induce fresh states of consciousness and not only unearth repressed memories, but when aligned with therapy help people re-evaluate them, and thus think differently about their future.

The first major insight we found was that psilocybin dampens down a part of the brain that is one of the driver hubs for depression, Nutt explains. We knew that antidepressants and psychotherapy did that, but usually it takes weeks or months to happen. With psilocybin, it happened within minutes.

The other conclusion Nutt and his colleagues drew was that psilocybin disrupted a part of the brain that contains our sense of self, a faculty that commandeers more brain activity in depressed people.

Sarah Bateup, therapy lead at the Clerkenwell clinic, believes that psychedelics like psilocybin could yield significant breakthroughs in mental healthcare. If youve had depression for 20 years, youve had therapy 10 times, youve tried every drug, youve had electroconvulsive therapy, and you dont get better, youre already thinking: Im not curable.

A psychedelic like psilocybin creates this window of opportunity, where the person is very open and more receptive to therapy, she adds. But she stresses that psychedelic-assisted therapy is a novel and highly challenging form of psychiatric care, and one that carries significant risks. After all, these substances are powerful and unpredictable.

Were being very robust, scientific and evidence based, Bateup says. We also think that its very important to strip out the symbolism that comes with psychedelics. If this is a medicine of the future, then it needs to be fit for world health systems its our responsibility to do high quality research, and show people that were boring scientists and clinicians, not people that have done too many drugs.

There is a growing interest in using other drugs, such as MDMA and ketamine in mental health treatments. Awakn, a life sciences firm with clinics in Bristol and London, is researching the potential for ketamine and MDMA to treat alcoholism, gambling addiction, binge eating, and sex addiction. In the US, treatments that include MDMA are likely to be approved soon for patients with post-traumatic stress disorder (PTSD), though regulator approval in the UK is likely to take longer.

Meanwhile, Compass Pathways, a mental health care company and developer of a synthesised psilocybin, has this year announced a collaboration with Kings College Hospital and South London and Maudsley NHS trust to accelerate research into emerging psychedelic therapies.

To ensure that Clerkenwell delivers safe and beneficial treatments, Bateup has devised a training programme to help therapists work across multiple conditions with a range of psychedelic compounds. The screening process has been extremely rigorous.

We dont just take people that have the right qualifications, Bateup says. Were looking for scientists and practitioners who can reflect on their work, take feedback, and always want to be learning.

It is this thorough approach that Roullier has also sought to champion. In 2021 he set up The Psychedelic Participant Advocacy Network (PsyPAN) with Leonie Schneider, another participant in the second Imperial trial. The non-profit aims to connect a global network of participants in psychedelic trials. By pooling together these lived experiences, they hope to help clinicians create more effective treatment models, and improve participant safety and wellbeing.

Although trials do indicate some successes, they are still limited and operating on a small-scale number of patients. These treatments may be very effective tools but its very important to push back a bit, Roullier advises. Weve gone from these drugs drive you mad to these drugs could cure this condition for ever. Even when psychedelics do work, Roullier stresses that they are not a quick fix. Roullier still suffers with depression, but he has not taken antidepressants since taking part in a second psilocybin trial in 2019, and regularly attends counselling sessions.

Im living proof that one trial doesnt fix you for ever. Psychedelics have huge potential, but it would be simplistic to say that they are the answer to the mental health crisis, Roullier cautions. We need to deliver these treatments as ethically and safely as possible, so they have the best chance of making it to market.

For Bateup, while psychedelic-assisted therapy is a challenging and nascent field, the biggest gamble would be to keep things as they are. Our mental health care system is pitiful and its getting worse. Treatment outcomes have stagnated. Nobodys invented anything new, she says. Theres a big group of people who are really suffering, and this could be something that makes a huge difference to them. Thats what I want. Thats what its all about.

Original post:

Inside the UK's new psychedelic drug trial clinic trying to treat depression and anxiety - iNews

Mark Rus, MSc., Chief Executive Officer and Director of Delix Therapeutics.

Clinical interest in psychedelic chemicalsclassic hallucinogens like LSD (D-lysergic acid diethylamide) and dissociative drugs like ketamineis becoming increasingly mainstream. In 2019, the U.S. Food and Drug Administration (FDA) approved a nasal spray called esketamine (Spravato) containing a ketamine-like compound for treatment-resistant depression.

Although ketamine and now esketamine are available in clinics, most psychedelic compounds remain illegal. Psilocybin, the magic ingredient in psychedelic mushrooms, is farthest down the path to FDA approval. Just a few weeks ago, researchers at NYU Grossman School of Medicine showed that two doses of psilocybin, a compound found in psychedelic mushrooms, reduce heavy drinking by 83 percent on average among heavy drinkers when combined with psychotherapy.

Besides the issue of legality, taking psychedelic compounds has risks. In addition to poisoning, there are long-term side effects that include memory loss, seizures, and anxiety. Also, the eponymous side effects of psychedelic compoundshallucinations (seeing the world turn into fractals, hearing voices, or tasting colors) and dissolution (feeling out of control or disconnected from their body and environment)pose a risk to serious harm because of the profound alteration of perception and mood. While not inherently dangerous, consumption of psychedelics has led people to harm themselves and others while having a mind-altering experience, with tales of people becoming suicidal and violent.

To harness the clinical power of psychedelics, the mechanism of action underlying the antidepressant and anxiolytic effects need to be separated from hallucinatory and dissolutive. Research has shown that result from their ability to promote structural and functional plasticity in prefrontal cortical neurons. Isolating the chemical structures driving the rapid and long-lasting antidepressant and anxiolytic effects of psychedelics may be used as lead structures to identify next-generation neurotherapeutics with improved efficacy and safety profiles.

Delix Therapeutics is a neuroscience company focused on harnessing the power of isolating psychoplastogensnovel neuroplasticity-promoting therapeuticsto better treat mental health disorders at scale. Based in Boston, Massachusetts, the companys compounds, which do cause not cause hallucinatory or dissociative side effects, are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted brain areas. Many of these molecules are inspired by psychedelic compounds and preserve their efficacy-promoting mechanisms while avoiding their hallucinogenic properties and other safety liabilities.

GEN Edge has taken a look into the motivation and structure of Delixs R&D pipeline with CEO Mark Rus, a veteran industry executive. He joined Atlas Venture after previously leading Shire Pharmaceuticals Global Neuroscience Business.

GEN Edge: What motivated the founding of Delix Therapeutics?

Rus: Neuropsychiatry and neurodegeneration have had a shortage of innovation for the past few decades. Were still using a similar selective serotonin reuptake inhibitor (SSRI). You cant even find meaningful advances on the neurodegenerative side. Pick your access moral, strategic, or financial. All roads lead to the need for better mental health treatments. The treatments do not match the unmet need in the space.

Through that motivation, Delix co-founder David Olson was working on ketamine at the Broad Institute on why these rapid structural and functional changes, called neuroplasticity, occur in the PFC. We know the intangible benefits associated with like ketamine or true psychedelics like psilocybin. Perceived dissolution of ego and the unique intrinsic experiences that one can have are very powerful. Who am I to say that those cant be the most transformative experiences for someone in their lives?

But Im a neuro drug developer, and Im more interested to know whats happening at the synapse or circuit-based level. It was inconceivable to me that structural and functional neuroplasticity did not play a role. That ultimately led to the foundation of Delix.

GEN Edge: How do psychoplastogens work?

Rus: If you think of a neuron as a trees trunk, the dendrite is the branch coming off that tree and the synapses or the leaves on the edge of the branches. A well-functioning circuit connective circuit of pre-frontal cortex (PFC) to other brain parts is like a rich forest, where the neurons are all connected. But then, in a scenario where theres trauma, whether genetic or external, in both cases, those leaves start falling off, the dendrite branches retract, and the synaptic connectivity in the circuit is essentially lost or suboptimal.

To me, thats a fascinating nexus that sits at the heart of a range of neuropsychiatric and neurodegenerative conditions. So, why do psychedelics seem to help so quickly and so robustly? Its an indisputable fact that there is a massive and significant growth in the dendritic spine density process called synaptogenesis. David and I felt it was worth pursuing and drawing that lineup further. There are great companies, people, and funding behind hallucinatory-based approaches. But what if you could do it without the hallucinatory-based approach and some other aspects that may be suboptimal for some of these compoundsside effects, like HERG inhibition, other than removing the hallucinations?

For any brand, product, or therapeutic, I ask: What does it mean to a patient? Is it going to help? Will it make a difference in motivating them to want to take it? What does it mean for a payer and the prescriber? Is it sufficiently simple or motivating enough to change an ingrained habit that physicians may have in treating a particular condition? What does it mean for pharmacists, psychologists, and others in terms of ease of use? What does it mean for policymakers?

What motivated the Delix story was whether we could pursue the neuroplasticity-focused element, tease that out, and subtly tweak known hallucinatory compounds to generate our own novel IP. These eventually become very different compounds that, inspired by the hallucinatory ones, become more tolerable and orally bioavailable. You can take them home and thus be scalable to fit the current care frameworks and speak to the scalability of manufacturing, commercial, and patient access.

GEN Edge: What advantages do psychoplastogens have over hallucinogenic psychedelics?

Rus: I saw an inherent scalability issue regarding first- or second-generation hallucinatory psychedelics. Its not a reason not to do it. People can and will be helped by those experiences, but spending eight hours in an inpatient treatment clinic with multiple therapists surrounding you to support you and to walk you through that mission is one of the reasons why Spravatowhich a lot of people were excited by, the first ketamine derivative that was approved launched by Janssen and justifiably created a lot of motivation for our space and approved by the FDAhasnt been a huge success. Its tough to get high throughput payers to pay for it, and people that want to come back to take it with that high degree of complexity. Now, many people have been and will be helped with it.

There is a wide proportion of patients with comorbidities who will never even be candidates for hallucinatory psychedelic therapy. For someone with bipolar, schizophrenia, or a history of psychosis, its not the first, second, or third thing youd want to take to risk exacerbating that condition. When you start moving in that neurodegenerative direction and particularly individuals who are perhaps older or later in life, the ability to build rapport with therapists is plausible for some, and for others, it isnt. Im not sure how one discerns that early on.

So, the need for more options is there. Theres a mix of scalability, comorbidity, and other related reasons. That makes a lot of sense for more treatments in our approach. And thats what the Delix approach was all about. We wanted to take this non-hallucinatory approach to validate it preclinically. Ive been searching for the right scalable approach in this space because I see the promise that rapid structural and functional neuroplasticity changes may bring.

Delix is a psychoplastogen platform company. We now have thousands of compounds at this stage at various stages of characterization. We have two candidates that we nominated last year and moved into IND-enabling studies. We are in the process of completing those now. Well be in phase one early next year to show the translatability of this non-hallucinatory reality in man, efficacy, and safety with our approach while continuing to characterize, develop, and nominate subsequent candidates. We have a pipeline that we can produce from our platform as we drive forward the Structure-Activity Relationships (SAR) and the related screening discovery full of the scheme.

GEN Edge: What is the Delix R&D pipeline scheme?

Rus: Were certainly inspired by the fact that this work has been going on for a long time. Were standing on the shoulders of a lot of great work that has been going on for decades in the hallucinatory psychedelic space. But all our novel chemical and composition matter-supported compounds are synthesized and built in-house and are inspired by predicate compounds.

We have a phenotypic-driven drug discovery engine. Each one of these lens tests produces compounds that fit the Delix narrative for what an eventual clinical candidate would be. The first thing we do is assess for psychoplastogenic propertiesif something is a compound generating robust neurite outgrowth. We look at targeted binding and functional assays that one would typically use and the classic battery of safety profiles you do in neuro-drug discovery, such as ADME and PK. Then, we quickly test for the likelihood of hallucinogenic properties and an efficacy profile. So, weve got a range of multiple assays we assess so that as early as possible in the process, we can take some compounds off the assembly line that we feel are likely to display hallucinogenic properties and separate them from the non-hallucinogenic ones.

We dont allocate resources, time, or effort to the early-stage compounds weve developed and synthesized that have robust IP but are likely to be hallucinogenic. Over time, I feel those could be good candidates for other companies who are better natural owners and stewards of the hallucinatory approach. Thats not our lane, but we have identified and can build compounds that perhaps have an optimized hallucinatory profile.

The preclinical to clinical translatability is not great for hallucinatory properties. Some pretty good models like head twitch and related rodent models also have a pretty good R-square value for not being hallucinatory in man. We test efficacy through assays such as the non-forced four swim test, where we do the highest possible bar and most possible assays to demonstrate effectiveness in early-stage rodent models.

We also directly compare the compounds that we find most attractive against positive and negative controls. How are they doing against ketamine for being rapid-acting and long-lasting? We also dont want to develop another SSRI or something you must take daily. We want to be a once a month, twice a month, once every two months therapy, not once a day. Finally, we look at safety, toxicology, and dosing models that inform eventual clinical candidate selection and then patient subtypes.

GEN Edge: What is Delixs approach to funding?

Rus: The syndicate you build is essential, not just from the capital perspective. Its important to build with investors who truly understand neuro-drug development and are interested in building a leading neuroscience company, not short-term investors. And were fortunate to have that syndicate, having raised about a hundred million last year through our Series A and convertible note round. We have great teammates from ARTIS Ventures, RA Capital Management, founding investor OMX Ventures, and others.

GEN Edge: Whats on the horizon for Delix?

Rus: We want to get into the clinic to demonstrate human translatability for a Delix compound ASAP next year and continue to advance our pipeline candidates out of our platform, ready to move into IND-enabling studies adjacent to those clinical studies from phase one. We feel that being the leading non-hallucinatory, psychoplastogen company globally is a step towards being a leading neuroscience company by 2030.

Were building out our headquarters, and well be moving in next year here in Massachusetts in Q1. We couldnt be more thrilled to have a shot at making a big meaningful difference in something that all of us face one way or the othereither with ourselves, loved ones, or friendswith the suboptimal standard of care in mental health.

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What A Trip: Delix Therapeutics is Treating Mental Health at Scale with Psychoplastogens - Genetic Engineering & Biotechnology News

Miami, Florida--(Newsfile Corp. - September 15, 2022) - HealingMaps, an informative and trusted psychedelic therapy search site announced today the close of $1 Million USD in seed round funding from eight investors. The round was led by Phyto Partners along with Ambria Capital. As part of the investment, Cody Shandraw, Managing Partner of Ambria Capital and Phyto Partners will take on the role as Board Chairman for HealingMaps.

"With its innovative UX, HealingMaps makes it easy for patients to search for services by location and medical specialty, then schedule appointments with just a few clicks," said Shandraw. "That ease-of-use combined with engaging content will be an important driver for the growth of this blossoming new healthcare field. I'm excited about the impact Healing Maps will have on the industry as a whole and I can't wait to see what the future holds."

Larry Schnurmacher, Managing Partner at Phyto sees the potential for HealingMaps to become a force in the emerging brain health megatrend. "Our investment into HealingMaps fits our strategy and thesis that people are increasingly focusing on their mind health as much as they focus on their physical health. HealingMaps provides information, education and resources for healthcare professionals and people seeking alternative mental wellness solutions. As the brain health megatrend takes hold, HealingMaps will be THE go-to website for PaaM (psychedelics as a medicine) and neuro-wellness."

"I don't think we could ask for two better partners to help lead HealingMaps into its next phase of growth," said Cory Jones, CEO of HealingMaps. "Mental health is experiencing a seismic shift right now, backed by an abundance of clinical research that shows the powerful impact of psychedelic compounds. With more and more psychedelic-assisted therapy retreats and clinics opening around the globe, patients need to know which ones they can trust, and which ones offer the right services. That's the value that HealingMaps provides, connecting people with cutting-edge resources so they can confidently decide which clinic and treatment is right for them."

Story continues

About HealingMaps Inc

HealingMaps was created as a source for individuals looking for accurate and honest information about psychedelic-assisted therapy and how to find qualified providers in their area. Inspired by the ground-breaking research and expanding access to these alternative treatments, HealingMaps is on a journey to become the world's most informative and trusted psychedelic-therapy search site. AND to reduce the friction between education & the path to an individual's healing - helping those that probably never knew that therapies would be available to them so close to home.

For more information, please contact:

Mark Goldhar, CFOTel: 902 478 7090Email: mark@healingmaps.comWebsite: https://healingmaps.com/

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/137171

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HealingMaps Announces $1 Million in Seed Funding to Power Growth in Psychedelic Therapy Industry - Yahoo Finance

A few days ago, Nav released his new album Demons Protected By Angels, which included features from Babyface Ray, Bryson Tiller, Don Toliver, Future, Lil Baby, and more. In a quick talk with HipHopDX, he revealed the moment he realized hed made it as a rapper which happened to be while he was on some psychedelics.

When I took mushrooms, I looked at myself from a third person perspective, he said, and I was like, Yo I f*ck with you dude. Dude really do this sh*t. Dude really take care of his mom, his family, everybody else. Boys is straight. What? Im real! Sounds like he had a good trip.

Nav also revealed in a different interview recently that he and Drake collaborated on a song that didnt make the cut for Demons Protected By Angels. We did a song. I feel we couldve done a better song and the timeframe was just not good, it didnt work out, he said. He added, Hes such a big artist that I didnt want to put the song on the album and have it take away from anything else on the album. You know, take away life from all the other moments.

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Nav Talks The Moment He Realized He Made It; It Involves Psychedelics - UPROXX

Objective: The authors provide an evidenced-based summary of the literature on the clinical application of psychedelic drugs in psychiatric disorders.

Methods: Searches of PubMed and PsycINFO via Ovid were conducted for articles in English, in peer-reviewed journals, reporting on "psilocybin," "lysergic acid diethylamide," "LSD," "ayahuasca," "3,4-methylenedioxymethamphetamine," and "MDMA," in human subjects, published between 2007 and July 1, 2019. A total of 1,603 articles were identified and screened. Articles that did not contain the terms "clinical trial," "therapy," or "imaging" in the title or abstract were filtered out. The 161 remaining articles were reviewed by two or more authors. The authors identified 14 articles reporting on well-designed clinical trials investigating the efficacy of lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, and ayahuasca for the treatment of mood and anxiety disorders, trauma and stress-related disorders, and substance-related and addictive disorders as well as in end-of-life care.

Results: The most significant database exists for MDMA and psilocybin, which have been designated by the U.S. Food and Drug Administration (FDA) as "breakthrough therapies" for posttraumatic stress disorder (PTSD) and treatment-resistant depression, respectively. The research on LSD and ayahuasca is observational, but available evidence suggests that these agents may have therapeutic effects in specific psychiatric disorders.

Conclusions: Randomized clinical trials support the efficacy of MDMA in the treatment of PTSD and psilocybin in the treatment of depression and cancer-related anxiety. The research to support the use of LSD and ayahuasca in the treatment of psychiatric disorders is preliminary, although promising. Overall, the database is insufficient for FDA approval of any psychedelic compound for routine clinical use in psychiatric disorders at this time, but continued research on the efficacy of psychedelics for the treatment of psychiatric disorders is warranted.

Keywords: Ayahuasca; Drug-Psychotherapy Combination; Lysergic Acid Diethylamide; MDMA; Psilocybin; Psychedelics.

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Psychedelics and Psychedelic-Assisted Psychotherapy

You wont need any mind-altering substances for this psychedelic trip. A 12,000-square-foot experience called Psychedelics: The Experiential Exhibition is coming to Toronto at the end of this month and tickets are now on sale.

The event is described as Canadas first immersive art show exploring the past, present and future of psychedelics.

The exhibition dives into societys complex and often controversial relationship with psychedelics. It will provide a unique edutainment experience, combining audio and visual elements into an informative and fascinating display.

Visitors can roam three floors featuring spectacular original works from a diverse lineup of more than 22 internationally-acclaimed artists, says the description.

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Every space will be dedicated to a different psychedelic substance and its historical and traditional uses.

Some of the highlights include an immersive peyote installation, a recreation of a 1960s Bay Area Acid Test, original images, and a fantastical video projection that explores the history and renewed popularity of psilocybin.

The grand finale is a 9-minute ayahuasca ceremony channelled via a shamanic totem in the second-floor ballroom, which is an audiovisual installation featuring lighting, sound, lasers, and projection mapping of a fully activated light sculpture.

My goal with the show is to, firstand foremost, provide guests with an entertaining and eye-opening experience, says the exhibitions producer James Drayton.

The testimonials are undeniable: patients with serious mental health conditions like PTSD, depression, anxiety or addiction are trying psychedelic therapies when nothing else has worked and reporting life-altering benefits,

My hope is that it also encourages learning, dialogue, and ultimately, destigmatization.

Sadly, it doesnt seem like there will be any magic mushrooms for sale on your way out, but the experience alone will definitely expand your mind.

Where: Lithuanian House, 1573 Bloor Street WestWhen: Wednesday to Sunday starting on September 30, 2022Cost: $30 per adult

Regional Editor, East Coast Lilly is a born and bred Toronto girl with a deep love for uplifting local stories. She has over 4 years of experience as an editor and has done some wildly unusual things to chase down a good story, like stake out Kyle Lowrys house and interview a professional candy taster. She also has a Husky named Freddy and an obsession with true crime.

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Toronto is getting a trippy psychedelics immersive exhibition this month - Curiocity

ByJulie Scharper

Psilocybinthe substance that puts the magic in magic mushroomscan help people emerge from depression, spur others to quit smoking, and even allow those facing terminal cancer to make peace with death.

The Food and Drug Administration and the Drug Enforcement Administration classified psilocybin as a "breakthrough therapy" for depression in 2018, a move many see as paving the way for the eventual approval of the drug as a treatment for mental health conditions. Patients are already clamoring for the treatment, which for many brings dramatic results in just a few sessions. The impending challenge? Training psychiatrists and other clinicians to administer psychedelics, which are significantly different from other classes of drugs prescribed for mental health.

A new $900,000 grant from the psychedelics-focused Heffter Research Institute will allow researchers from Johns Hopkins, Yale University, and New York University to build out a postdoctoral fellowship and gold-standard training program in psychedelic therapy. While some organizations have certification programs in psychedelics, they are often based on anecdotal observations, not hard data. "What is missing is an evidence-based approach," says Natalie Gukasyan, a Johns Hopkins assistant professor of psychiatry. Gukasyan, who is also medical director for the Johns Hopkins Center for Psychedelic & Consciousness Research, is leading Hopkins' efforts on the project.

Humans have been experimenting with psychedelics for millennia, but the substances first caught the attention of scientists in the 1950s when American banker R. Gordon Wasson wrote in Life magazine about his experiences taking hallucinogenic mushrooms with an Indigenous Mexican healer named Mara Sabina. More than 1,000 studies on psychedelics were launched between the mid-1950s and the early 1970s, but the drugs' association with hippies and Harvard-psychologist-turned-counter-culture-icon Timothy Leary led to fear and condemnation. In 1970, President Richard Nixon signed the Comprehensive Drug Abuse Prevention and Control Act, which outlawed psilocybin, LSD, and other psychedelics and effectively ended research on the drugs for more than two decades.

In 1993, David Nichols, at the time a psychopharmacology professor at Purdue University, formed the Heffter Research Institute to support plans to reinitiate studies of psychedelics. And in 2000, Roland Griffiths, a Hopkins psychiatry and neuroscience professor received FDA approval to begin studying psilocybin at Hopkins. Over the decades that followed, Griffiths has created protocols for using the hallucinogenic drug in clinical settings and led dozens of studies showing the safety and efficacy of psilocybin. The Center for Psychedelic & Consciousness Research opened at Hopkins in 2019 with Griffiths at the helm. More than 40 researchers now work at the center on studies looking at the effects of psilocybin on anorexia, smoking, major depressive disease, Alzheimer's disease, and other conditions.

The Heffter grant will enable psychedelics experts to put together a one-to-two-year postdoctoral fellowship program for psychiatrists interested in using psilocybin and other psychedelics in their practice. Fellows will learn about screening and preparing patients for psychedelic therapy, dosing, creating the right setting and mindset for the treatment, and providing psychotherapy to those undergoing treatment with psychedelics. Additionally, researchers will put together an evidence-based curriculum that will encompass the latest research on psychedelic therapies, Gukasyan says. Each university will receive $300,000 over the next two years to fund the creation of the program.

Gukasyan is "cautiously optimistic" that the Food and Drug Administration and the Drug Enforcement Administration will approve psilocybin for clinical use in the next five years or so, but there is no guarantee. The program will also train psychiatrists in other clinical interventions involving unusual states of consciousness, including Holotropic Breathwork, a breathing technique that puts participants in an altered state of mind.

Assuming the federal government clears the way for psilocybin to be used by clinicians, the materials crafted by the teams from three universities will provide a guidepost for creating other fellowships and training programs, Gukasyan says. "There is a lot of interest in psychedelic therapy because not only is it effective quickly, but it is highly effective," she says. "People are excited about these early results. The best we can hope for is that [clinicians] will be able to have this tool in their toolbox."

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Preparing for a new era of psychedelic treatment - The Hub at Johns Hopkins