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Category Archives: Psychedelics

Congressman Says Psychedelics Show ‘Real Promise’ As Alternative Therapies At Committee Hearing – Marijuana Moment

Posted: September 29, 2022 at 1:04 am

As a House committee takes steps to broadly improve patient access to healthcare, one congressman is taking the opportunity to call for a conversation about the therapeutic role of psychedelics like psilocybin, which he says have real potential as alternative mental health therapies with less impact than traditional pharmaceuticals.

Rep. Earl Blumenauer (D-OR) spoke about the therapeutic potential of psychedelics on Wednesday during a House Ways & Means Committee markup of several bills related to worker and family health support that arent directly related to drug policy reform.

The congressman, who has long championed marijuana legalization and become one of the most outspoken members on Capitol Hill advocating for psychedelics reform, said hes encouraged with the spirit with which were moving forward being able to integrate a variety of areas for reform as the panel works to address issues like outpatient care.

Were overwhelmed, in community after community, with the stresses that weve seen, particularly amid the coronavirus pandemic, Blumenauer said, adding that we need to continue moving forward.

He suggested that psychedelics policy should be part of the larger conversation about health care improvements, noting his interest in giving terminally ill patients access to investigative drugs like psilocybin, for example.

Oregon is involved in an experiment with therapeutic psilocybin that is indicating that theres some real potential to be able to deal with addiction, to deal with some of the end-of-life care in ways that have less impact than some other traditional therapies that I think have a lot to commend them, the congressman said, referencing his states historic 2020 vote to legalize psilocybin healing centers.

While those facilities havent opened yetand officials in a number of Oregon localities have moved to put measures opting out of allowing the services in their jurisdictions on the November ballotthe states vote has contributed to the burgeoning conversation about psychedelics policy in Congress.

I appreciate our colleagues being interested in the elements [of improving health care] here to try and broaden flexibility now, and committed to the future, but I think that this is an area that the committee is going to have to spend a lot of time on going forward, the congressman said.

At the beginning of this year, Blumenauer led a bipartisan letter requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution under federal Right to Try (RTT) law.

Bipartisan and bicameral congressional lawmakers then filed companion bills in July to clarify that RTT statute enacted under the Trump administration is meant to give those seriously ill patients access to Schedule I drugs, including marijuana and psychedelics like psilocybin and MDMA.

Meanwhile, congressional appropriations leaders have included language in recent spending legislation that urges federal agencies to continue supporting research into the therapeutic potential of psychedelics.

In July, the House voted in favor oftwo psychedelics-related amendments to a defense bill, including one that would require a study to investigate psilocybin and MDMA as alternatives to opioids for military service members and another that would authorize the defense secretary to provide grants for studies into several psychedelics for active duty service members with PTSD.

Marijuana Moment is tracking more than 1,500 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

But while advocates are encouraged by these incremental developments amid the national psychedelics decriminalization movement, some lawmakers feel that Congress isnt keeping pace with the public and the science.

Rep. Jared Huffman (D-CA) told Marijuana Moment earlier this month that hes done his research and believes that natural plants and fungi like psilocybin can be a therapeutic game changer, but he said that its embarrassing how slow other federal lawmakers have been to evolve on the issue.

Federal health officials have taken note of the increased adult use of certain entheogenic substances. As National Institute on Drug Abuse (NIDA) Director Nora Volkow put it earlier this year, the train has left the station on psychedelics.

The U.S. Department of Health and Human Services (HHS) recently said that it is actively exploring the possibility of creating a task force toinvestigate the therapeutic of certain psychedelicslike psilocybin and MDMA in anticipation of federal approval of the substances for prescription use.

That came in response to letters from bipartisan congressional lawmakers, state legislators and military veterans, who implored the HHS secretary to to consider establishing an interagency taskforce on the proper use and deployment of psychedelic medicine and therapy.

As the psychedelics conversation picks up in Congress, local and state lawmakers from across the political spectrum have showed significant interest in the issue in recent years.

Last week, for example, the Hazel Park, Michigan City Council approved a resolution designating September as a month of awareness of the therapeutic potential of psychedelicsmaking it the second city to take the symbolic additional step after locally decriminalizing natural plants and fungi.

Also this month, Atlanta lawmakers met to discuss a proposed resolutionin support of locally decriminalizing psychedelics, hearing testimony on the therapeutic benefits of entheogenic substances and discussing a plan to further consider the reform in a work session.

The hearing happened just weeks after a Georgia House committee met at the state level to separatelytalk about the therapeutic potential of psychedelicslike psilocybin to treat serious mental health conditions that commonly afflict military veterans.

Lawmakers in Missouri recently met to discuss possible solutions to the military veterans mental health and suicide crisis, with several people testifying aboutthe possible therapeutic potential of psychedelicsfor the at-risk population.

And this month, local San Francisco lawmakers unanimously approved a measure calling for the decriminalization of psychedelicslike ibogaine and ayahuascalocally, in the state and federally.

That resolution pointed out that the state legislature has already started the conversation around the decriminalization of personal possession of small amounts of seven psychedelic substances, in the form of a bill from California Sen. Scott Wiener (D) that passed the Senate and several Assembly committees before being significantly scaled back in a final paneland ultimately pulled by the sponsor.

Local psychedelics decriminalization has been enacted in several major cities in recent years, including Oakland, Santa Cruz and Seattle. A slew of Massachusetts cities have taken similar steps. Voters in the nations capital of Washington, D.C. also decriminalized.

This November, Colorado voters will get the chance to make history once again, with an initiative to legalize psychedelics possession for adults and create psilocybin healing centers in the state.

A top Canadian health official who heads up the countrys efforts to combat addiction recently visited Colorado, Oregon and Washington State last week to learn about their experiences implementing drug policy reform like broad decriminalization and harm reductionmeeting with the governor of Oregon and psychedelics activists, among others, on a week-long tour.

Oklahoma Supreme Court Says Marijuana Legalization Wont Be On November Ballot, But Will Be Voted On In Future Election

Image courtesy of Kristie Gianopulos.

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Psychedelics and mental health: the potential, risks and hype – WHYY

Posted: September 27, 2022 at 8:50 am

Theres a lot of excitement around the potential for psychedelics to treat a host of psychiatric problems. Drugs like ketamine, MDMA (often known as Molly or Ecstasy), and psilocybin, the hallucinogenic substance in magic mushrooms, are being studied to treat depression, anxiety, substance disorders and PTSD.

An increasing body of research shows these plant-based compounds have promise. For example, a recent small study found psilocybin dramatically reduced excessive drinking in people with alcohol use disorder. This is good news for people suffering from mood or substance use disorders who havent found relief through other therapeutics. Theres also a lot of hype surrounding these compounds, and many businesses trying to cash in on the psychedelic boom by offering therapy, products, retreats and more.

Today, a conversation about psychedelics in mental health treatment, their potential, and risks. Well talk about how these drugs affect the brain, altered states of consciousness and the stigma still associated with them.

Guests

David Yaden, Assistant professor at Johns Hopkins University School of Medicine working in the Center for Psychedelic & Consciousness research. Hes the co-author, with Andrew Newberg, of the new book, The Varieties of Spiritual Experience: 21st Century Research and Perspectives. @existwell

Ron Millward, an Air Force combat veteran andFounder and President of Balanced Veterans Network, an organization that provides education and advocacy of alternative therapies for veterans and their families.

The New York Times, The Promises and Perils of Psychedelic Health Care Many recreational drugs known for mind-altering trips are being studied to treat depression, substance use and other disorders. Heres what you need to know.

Wired, Is the Psychedelic Therapy Bubble About to Burst? A new paper argues that excitement has veered into misinformationand scientists should be the ones to set things straight.

Bloomberg, Get Ready for the Magic Mushroom Pill The medical benefits of psychedelic drugs have gone from Age of Aquarius punchline to solid science, but the startups racing to market might still be getting ahead of themselves.

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Psychedelics and mental health: the potential, risks and hype - WHYY

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Is Now a Good Time to Invest In Psychedelics Stocks? – The Motley Fool

Posted: at 8:50 am

As strange as it might sound, there's reason to believe that companies developing mental health therapies based on psychedelic chemicals will make it big someday. With a drumbeat of impressive clinical trial results for using drugs like psilocybin in indications like treatment-resistant depression (TRD) building by the quarter, it's likely a matter of time until psychedelic medicines are commercially available.

Nonetheless, nobody's done it yet, meaning investors will need to be comfortable with significant risks if they choose to invest. There are a few compelling arguments in favor of buying shares of these companies now -- but there are also compelling arguments in opposition, so let's dive in.

One reason why now's a decent time to buy psychedelics stocks is that there's an ongoing fire sale across the entire industry, thanks to the bear market.

Leaders like COMPASS Pathways (CMPS -2.46%) and Atai Life Sciences (ATAI -2.48%) have seen better days. Shares of Atai are down by around 79.6% in the last 12 months, and shares of COMPASS are down by more than 61.3%. What's more, they might get even cheaper over the coming months if the market continues to fall.

And since both companies are still developing their first psychedelic therapy, buying shares in the near term will give investors the benefit of price appreciation if they report positive clinical trial results or favorable regulatory outcomes. As it's likely to take years before either of the pair has a chance to generate revenue, there isn't exactly a time pressure for investors to buy shares now, though.

Another reason why psychedelics stocks are attractive at the moment is that the legality of psychedelic compounds in the U.S. is slowly starting to shift in a direction that favors the industry. Right now, psychedelics are illegal federally. But, as of late 2020, the active component of psychedelic mushrooms, psilocybin, has been decriminalized in the state of Oregon. And a handful of municipalities, including well-known cities like Washington D.C., Ann Arbor, Maryland, and Oakland, California, have followed suit.

As if that weren't enough, this summer, Congress saw bipartisan efforts to amend this year's National Defense Authorization Act (NDAA) to enable the Department of Defense (DOD) to spend money to study psychedelics for their utility in treating post-traumatic stress disorder (PTSD). If the NDAA passes as it is and it gets signed into law, it's plausible that psychedelics stocks will get a bump, but the far more important takeaway will be getting another piece of evidence that prohibition is finally starting to thaw slowly.

For most investors, lower-priced shares and some marginal progress with the legal situation aren't exactly the most compelling reasons to buy psychedelics stocks. More importantly, the level of risk associated with the industry is still sky-high, and that won't be changing anytime soon.

Psychedelics companies face three serious risks. The first is that their therapies will fail to be proven safe and effective at treating mental illnesses in clinical trials. That risk is largely shared with other biotech stocks, but it's actually elevated in this context because even basic details about best practices for treatment protocols are still undetermined.

For example, COMPASS' lead program, COMP360, is a combination of psychological support from trained therapists and administration of a stabilized version of the drug psilocybin. Formulating a therapeutic molecule is a problem that many other biotechs have successfully navigated in the past, but developing an in-clinic psychedelic treatment protocol and a training regimen for the clinicians who will administer it is entirely new ground.

The second risk is that whatever psychedelic treatments companies devise will fail to be commercially viable even if regulators agree that they're safe and effective. COMPASS' model for COMP360 requires patients to visit specialized clinics that are staffed by highly paid professionals. It's unclear how much a course of COMP360 might cost, and it's also unclear whether public and private insurers would be willing to help patients.

And with that, we've arrived at the third major risk: Psychedelic therapies are still illegal for medicinal use in the U.S., as well as in much of the Western world. There's simply no way for any business to commercialize a psychedelic medicine until that changes, even if clinical trial results are favorable and the expected economic returns are massive. The recent progress on this front is nice, but it's so preliminary that it isn't enough to invest on.

So, at the moment, psychedelics stocks are highly speculative and will probably continue to be for at least a few more years. If the thoughts of losing all your money or needing to wait for years before your investment breaks don't scare you, invest away to take advantage of low prices. On the other hand, for most investors, it's probably a smarter move to invest where you can have a little bit more certainty of a positive return.

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Is Now a Good Time to Invest In Psychedelics Stocks? - The Motley Fool

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I went to the only psychedelic dispensary in North Americaheres how they do it – The Manual

Posted: at 8:50 am

A Chinese woman of about sixty years old entered the shop, approached the counter fast without hesitating to check out the trippy posters that decorated the walls nor the far-out substances on display behind glass next to the register, and launched right into it.

I dont know anything about mushrooms. My friend gave me a mushroom pill and said that it would make me happy again, and it worked, she said. Now her posture shrank a little and her voice became quiet. I just want to be happy again.

Of course you do! The woman seated behind the counter smiled and then delivered a cursory explanation of how research showed that psilocybinthe psychotropic compound in so-called magic mushroomscould be a highly effective treatment for depression and other mood disorders. Then she launched into an overview of the different mushrooms they had for sale, ultimately recommending that the woman start out by trying microdosing. She set a little box on the counter, and the customer (or patient, perhaps) eyed it warily.

This isnt going to turn me into a crying mess, will it?

Not these. The cashier shook her head, then gestured to a different product. These will.

Located in Vancouver, BCs troubled downtown junkie district of East Hastings, the Medicinal Mushroom Dispensary is a truly one-of-a-kind establishment. In this humble shop, one can buy various forms of mushrooms, LSD, DMT, peyote, and a range of other substances. Theres also an onsite cafe where you can buy drinks made with coca leafthe plant that can be processed into cocaineas well as the cheapest sandwiches in town.

While shifting attitudes toward psychedelics have resulted in the gradual introduction of a range of psychedelic businessesor at least psychedelic-adjacent businessesacross Canada and the U.S. (Mexico has long turned a blind eye to cafes selling psychedelic mushrooms in a handful of remote villages in the mountains of Oaxaca, though these have always struck me less as proper businesses than straight up witches huts), this is the only dispensary on the continent to go all-in in terms of selling the strangest of the strange. Psychedelics are illegal in Canada, so how does the Medicinal Mushroom Dispensary operate legally?

Simply put, it doesnt. When asked, a member of the staff told me something about operating in a legal grey area, but it turns out that theres nothing legal or grey about it. Its outright illegal. Butperhaps by the grace of the DMT elvesthe Fuzz has elected to look the other way.

When pressed on why the police nor the city have moved to shut the business downlet alone make any arrestsrepresentatives of both have expressed that theyre more concerned with addressing the opioid crisis rather than wrestling with the increasingly embraced psychedelic scene. It probably isnt a stretch to guess that they see the writing on the wall. Psilocybin mushrooms and ketamine are already allowed in Canada for patients with certain health conditions, and it likely wont be long before natural substances like mushrooms and peyote gain fully decriminalized if not legal status. Synthetic substances like MDMA and LSD might be slower to the decrim/legalization party, but theyre on the horizon.

Just because the shop flaunts the law doesnt mean that they dont have a mind for safety considerations. Beside the register are several stacks of educational material explaining the benefits and risks associated with each substance. And new initiates to the clubfor customers must become card-carrying members before they can buy any of the stronger substances (a policy that is almost certainly intended to ward off certain legal challenges)receive detailed guidance on how to safely use the drugs.

Having spent a good amount of time hanging around the store sipping cocaccinos and taking in the vibe, I can report that its owner and staff are benevolently dedicated to the psychedelic cause. This is no cynical venture attempting to capitalize on a fast-rising trendthese people are out to help those in need.

And there is no greater reminder of the importance of that help than the neighborhood in which the dispensary operates. The ravages of the opioid crisis are all-too-obvious on the sidewalks of East Hastings, and studies have repeatedly shown that psychedelics can be a powerful tool for treating addictionfar more effective, statistically, than any other treatment we have at our disposal. Beyond addiction, depression and anxiety have reached epidemic proportions, and here again, science has shown that psychedelics can be a highly effective solution.

So while the existence of the Medicinal Mushroom Dispensary is awesome (or perhaps radicalin the 1990s sense of the wordis a more accurate descriptor), its also important to the community it serves.

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Psychedelic drugs: how to tell good research from bad – The Conversation Indonesia

Posted: at 8:50 am

Research with psychedelic drugs has made a dramatic comeback amid a heady mix of softening societal attitudes, the lure of commercial opportunity, misgivings about the war on drugs, and the desire to develop new ways to treat mental health conditions.

So you might have read in the media that theres a new study which shows that ketamine can banish depression, or psilocybin is effective at treating post-traumatic stress disorder, or microdosing LSD makes you more creative.

In this fervour, which research is worth your time and, more importantly, your trust? Of course, whats worth your time depends on what you want.

Im a doctor, a drug researcher and a clinical trialist. As such, Im interested in whether psychedelic therapy can be a new form of medicine. That question needs clinical trial evidence. Thats what Ill be concentrating on here, although some of the principles apply to medical research more broadly.

First, your source. Good scientific research is published in peer-reviewed scientific journals. Peer reviewed means that independent experts have read and anonymously criticised the paper. This is an important form of scrutiny. If the journal youre looking at does not support peer reviewing, move on.

Some journals claim to be high-quality enterprises, publishing peer-reviewed articles but are actually pop-up money-making schemes that publish anything.

Spotting these is a bit like spotting a spam email or social media post. Poor grammar, spelling and formatting mistakes, substandard websites and too-good-to-be-true statements are all telltale signs of a journal that wouldnt let the truth get in the way of a good publishing fee.

In contrast, good quality journals are generally long established, are indexed in scientific databases such as PubMed, and usually have good impact factors (a measure of how often the journals papers are cited). While this isnt a perfect metric, it is useful as a guide, and it will be stated on the journals homepage. A higher number is more reassuring.

With a good quality journal, youre halfway there.

Before you read anything about the paper, look to see who the authors are, where they work and what their disclosures and funding sources are (this is usually stated at the end of an article). Authors who are top of their field often have great reputations.

But they also have more to lose by results that dont fit their theories. They are more likely to be paid consultants for companies seeking to commercialise new treatments, too.

Similarly, just because a study comes from a pioneering, high-quality institution doesnt mean you should blindly trust it. In fact, those very teams that were the pioneers are precisely the ones who might also be heavily biased. Put another way, why would we have got into such a stigmatised field if we didnt hold a strongly positive preconception?

That said, institutions and research teams with good reputations earn them because their peers respect their methods and believe their results. So, overall, go for the most well-respected authors, but have in the back of your mind the other factors at play.

Now take a look at the paper itself. For clinical research, the multi-centre, randomised, placebo-controlled trial is king. Almost all psychedelic research is not this (yet).

Initial trials take place in one institution. Thats fine, but it doesnt say anything about whether the treatment works beyond that institution. For that, you need a multi-centre trial. The more centres, the better.

If it works in lots of centres, theres more reason to believe itll work in the real world. This is called generalisation, and its an unanswered question for psychedelics.

Randomised and placebo-controlled refer to the participants being randomly allocated to two or more groups, one of which is treated with a placebo (dummy pill). Unless you have a placebo control group to compare with, you dont know if the effect you observe in the treatment group might not have happened anyway.

Similarly, if there is no randomisation, then any effect you observe might be due to something else common to one of the groups.

Early psychedelics trials were often not randomised or controlled. Thats fine, but you cant conclude much from these pilot studies. They just show that the research can be done.

The more participants a trial has, the more statistical power it has to detect a true effect (or a true absence of an effect). This often needs hundreds, even thousands, of participants.

These trials cost a lot, which is why many large-scale clinical trials are funded by companies - its the only way to raise the money to get the trial done. But dont dismiss commercial trials.

Yes, profit and healthcare arent easy bedfellows. But commercial trials are far more heavily regulated than non-commercial trials. Almost all the medicines we have today were licensed based on commercial trials.

All clinical trials should have a pre-registered primary outcome. The primary outcome can be anything: a blood test result, a neuroimaging finding, or a measure of depression. It is that outcome that the trial is designed around.

Pre-registering happens on websites like clinicaltrials.gov before the trial starts. If the researchers havent pre-registered their hypothesis, their primary outcome measure and their methods of analysis, then they could have cherrypicked the results youre reading.

Put another way, if you torture your data hard enough, it will tell you whatever you want. This is one of the great research sins.

If I flip a coin ten times, then keep doing that again and again, at some point Ill get ten heads, just by chance. Its the same principle here. The more measures I put in a trial, and the more ways I choose to analyse the data, the more likely Ill get a significant result.

A final thought before you go. No one clinical trial or piece of research can tell you anything for certain. The more a result is replicated, the more believable it becomes.

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The Connection Between Psychedelics and Grief – Psychedelic Spotlight

Posted: at 8:50 am

Psychedelics and grief share a surprising kinship. Both are shrouded in societal taboos and folklore mysticism that places them at cultural outskirts and conversations. More importantly, they are both a delicate, natural and ancient human experience that it seems the world may finally be ready to learn not just about but learn from.

What we know well is that grief is an emotional and bodily traumatic event that rewires the brain, much like PTSD. When a bond is formed, there are significant changes to the way those proteins are folded in the nucleus accumbens of the brain. Over time, our neurons are devoted to firing in a certain pattern and with it, devoted to this bond or a partner. The nucleus accumbens plays a motivational role in our reward system responsible for feeding, sexual behavior, stress and drug self-administration, aka addiction. Drugs like heroin and cocaine activate and disrupt this same reward system. The comparison between love and its drug-like addictive effects is a widespread theme, but we are growing privy to the fact that grief chemically functions along that same neural pathway. The lacking bond or missing person causes this loss to be a shock to our reward, nervous, limbic and physiological systems. In other words, it rocks your entire world and in a devastating way at first.

Neurologist, Lisa M. Shulman says that grief is an evolutionary adaptation to promote survival in the face of emotional trauma. Thinking of grief as a tool for transformation is a relatively new idea. Most household conceptions about grief are in fact outdated like the five stages of grief otherwise known as The Kbler-Ross model introduced by Elisabeth Kbler-Ross in 1969. This model was actually shaped off of the series of emotions experienced by a person who is dying, not necessarily grieving. It still became a tangible and accepted explanation of the complex and abstract emotional upheavals one experiences during the varying phases along their grief journey. The last stage was once reaching a point of inevitable acceptance, but it was her protege and partner, David Kessler, todays most popular media expert on Grief and Grieving, that shifted the laymans narrative in 2019 with his book Finding Meaning: The Sixth Stage of Grief. Since then, new-age grief work like experiential retreats or writing workshops such as the Make Meaning Workshop, provide avenues to alchemize their grief into meaning.

This critical sixth step to find meaning offers a bridge between grief and a more fulfilled and emotionally balanced life. But this innate ability to adapt to the shock of grief by making meaning from it was explored in Dr. Robert A. Neimeyers book Meaning Reconstruction and The Experience of Loss published in 2001. Very similar to psychedelic integration models, Neimeyer discusses Meaning-Reconstruction Theory as the capacity to reconstruct, reshape and rethink our experiences or stages of bereavement to initiate recovery and personal growth beyond our previous capacities.

This seemingly simple sixth step of grief can present itself as a perilous and daunting task for the average bereaved person, but if one successfully practices the process and skill of creating or reconstructing meaning, then one successfully integrates a new evolutionary coping mechanism and life tool for the brain, body and spirit.

It is an emotional excavation and reconstruction that asks us to explore the depths and caverns of our most treacherous memories to essentially form new bonds in the brain. This is where psychedelic-assisted therapies come into play for those seeking more holistic and nuanced approaches to overcome prolonged grief. Psychedelics help those grieving in the similar ways that psychedelics have been proven to help heroin addicts, PTSD victims and those who have experienced traumatic events. They help access memories and pivotal events that have negatively altered the reward system in order to confront and offer their brain a path to reconstruct them in a positive way.

New-age grief work looks at symptoms of bereavement or stages of grief as opportunities or entry points for meaning reconstruction to take place. Psychedelic-assisted therapies provide a catalyst to meaning reconstruction, among countless other benefits. Nonetheless, new-age grief work and psychedelic-assisted therapies have similar methodologies. They encourage self-exploration and the notion that we have all we need within ourselves to find true healing and growth if we can only take the pieces of what was to create and admire what now is.

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Effects of LSD and Psilocybin in Healthy Participants – Psychiatric Times

Posted: at 8:50 am

RESEARCH UPDATE

Lysergic acid diethylamide (LSD) and psilocybin are serotonergic psychedelics that are candidates for the treatment of psychiatric disorders.1-4 Both agents stimulate serotonin 5-HT2A receptors; LSD also acts at dopamine D13-3 receptors, and the active metabolic of psilocybin (psilocin) inhibits the serotonin transporter.5 The similarities, acute effects, and dose equivalence of these agents in humans remains unclear.

The Current Study

Holze and colleagues6 directly compared the acute subjective, autonomic, and endocrine effects of LSD and psilocybin at 2 doses and placebo within the same participants. The acute subjective effects of these agents were assessed with validated psychometric instruments, and pharmacokinetic data were obtained over 24 hours. The investigators performed a double-blind, placebo-controlled crossover study with 5 experimental test sessions (placebo, LSD 100 g, LSD 200 g, psilocybin 15 mg, psilocybin 30 mg), with a washout period of at least 10 days between sessions.

The authors recruited 28 healthy participants; their mean age was 35 years and 50% were male. Exclusion criteria were: age less than than 25 years or greater than 65 years, pregnancy, family history of major psychiatric disorders in first-degree relatives, current psychotropic medication use, acute or chronic physical illness, tobacco smoking of more than 10 cigarettes/day, lifetime illicit drug use exceeding 10 times (except use of tetrahydrocannabinol [THC], the principal psychoactive cannabinoid of cannabis), or illicit drug use in the past 2 months or during the study period. In terms of previous drug use, 11 participants had previously used LSD and 6 had previously used psilocybin; 13 had previously used a stimulant; and 10 participants had no history of noncannabis illicit drug use. LSD was administered as an oral solution and psilocybin as an oral capsule. A double-dummy method was used such that participants received 6 capsules and 2 solutions at each test session.

Each test session lasted 25 hours and was conducted in a calm hospital room. Abstinence from illicit drugs was verified with a urine drug screen. Outcomes were repeatedly assessed for 24 hours. Standardized meals were served. An investigator was present in the room during the acute effect phase and remained in a room next to the participant for up to 24 hours. Subjective effects were assessed repeatedly using visual analogue scales (VAS), the Adjective Mood Rating Scale (AMRS), the 5 Dimensions of Altered States of Consciousness scale (5D-ASC), and the Mystical Effects Questionnaire(MEQ). Effect durations were assessed using the classic pharmacokinetic-pharmacodynamic link module. Blood pressure, heart rate, and temperature were repeatedly measured. Adverse effects were assessed 1 hour before and 12 and 24 hours after drug administration. Plasma LSD and psilocybin concentrations, and cortisol, prolactin, oxytocin, and brain-derived neurotrophic factor (BDNF) measurements were also obtained at multiple time points. Pharmacokinetic parameters were estimated using noncompartmental methods. Peak drug effects (minimum, maximum, or change from baseline) were determined for repeated measures, then analyzed using repeated-measures analysis of variance.

Both doses of LSD and the 30-mg psilocybin dose produced comparable subjective effects, based on VAS and 5D-ASC outcomes. There was significantly greater ego dissolution and a trend toward greater anxiety with 200 g versus 100 g LSD. Psilocybin 15 mg had significantly lower effects than psilocybin 30 mg and both LSD doses, based on VAS and 5D-ASC outcomes. Both LSD doses had significantly increased emotional excitation on the AMRS compared with psilocybin. There were no differences in subjective effects of LSD or psilocybin based on sex.

Both LSD and psilocybin significantly increased systolic and diastolic blood pressure, temperature, and pupil diameter compared with placebo. Psilocybin 30 mg produced significantly greater increases in blood pressure and temperature compared with psilocybin 15 mg and both doses of LSD. By contrast, both LSD doses produced a greater increase in pulse compared with both psilocybin doses and placebo. Psilocybin produced greater impairments in pupil contraction compared with LSD. Both LSD and psilocybin increased the total acute (0-12 hours) adverse effect score compared with placebo. Subacute (12-24 hours) adverse effect scores were significantly greater with LSD 200 g LSD and psilocybin 30 mg compared with placebo. The most common adverse effects were headaches. Five participants had 9 flashback episodes within 72 hours. No severe adverse events were observed.

Both LSD doses had significantly longer effect durations (10-11 versus 6-7 hours) and earlier onset of effects (0.4-0.6 versus 0.8 hours) compared with both psilocybin doses. The elimination half-life values were about 4 hours for LSD and 2.5 hours for psilocybin. Both LSD and psilocybin significantly increased plasma cortisol, prolactin, and oxytocin levels, but neither affected BDNF levels. Both LSD and psilocybin showed linear pharmacokinetics, which were not influenced by body weight.

In terms of blinding, no clear distinction between LSD and psilocybin could be made after the session or at study end point. Participants correctly identified the psychedelic and dose in about 60% of sessions, compared with 96% for placebo.

Study Conclusions

The authors investigated and directly compared the acute effects of LSD and psilocybin in healthy participants in a well-blinded study. They concluded that psilocybin 15 mg exerted clearly weaker subjective effects, and both agents had dose-dependent effect durations (significantly longer for LSD), stimulant autonomic effects, and increased endocrine parameters. Body weight had no influence on blood concentrations. The investigators noted the data further supported the notion that states of consciousness alteration induced by LSD and psilocybin are more likely dose-dependent rather than substance-dependent. In addition, they concluded the differences in the pharmacological profiles of LSD and psilocybin do not relevantly influence subjectively experienced effects of both psychedelics.

Study strengths included the within-subjects design and the use of well-characterized, fixed dosing. The primary study limitations were the use of a highly controlled setting and the participation of healthy participants only.

The Bottom Line

This study supports dose finding for research and psychedelic-assisted therapy. Psilocybin 20 mg is likely equivalent to LSD 100 g. There was no evidence for qualitative differences in altered states of consciousness, except for a shorter duration of action for psilocybin.

Dr Miller is a professor in the Department of Psychiatry and Health Behavior, Augusta University, Augusta, GA. He is on the Editorial Board and serves as the schizophrenia section chief for Psychiatric Times. The author reports that he receives research support from Augusta University, the National Institute of Mental Health, and the Stanley Medical Research Institute.

References

1. Carhart-Harris R, Giribaldi B, Watts R, et al. Trial of psilocybin versus escitalopram for depression. N Engl J Med. 2021;384(15):1402-1411.

2. Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197.

3. Davis AK, Barrett FS, May DG, et al. Effects of psilocybin-assisted therapy on major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2021;78(5):481-489.

4. Gasser P, Kirchner K, Passie T. LSD-assisted psychotherapy for anxiety associated with a life-threatening disease: a qualitative study of acute and sustained subjective effects. J Psychopharmacol. 2015;29(1):57-68.

5. Rickli A, Moning OD, Hoener MC, Liechti ME. Receptor interaction profiles of novel psychoactive tryptamines compared with classic hallucinogens. Eur Neuropsychopharmacol. 2016;26(8):1327-1337.

6. Holze F, Ley L, Muller F, et al. Direct comparison of the acute effects of lysergic acid diethylamide and psilocybin in a double-blind placebo-controlled study in healthy subjects. Neuropsychopharmacology. 2022;47(6):1180-1187.

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Cannabis And Psilocybin May Have Helped This Woman’s Breast Cancer Treatment – IFLScience

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A 49-year-old woman with advanced metastatic breast cancer has successfully halted the spread of the disease with chemotherapy alongside cannabis oil and magic mushrooms, according to a new case report. After halting her conventional cancer treatment, the patient remained disease-free for 18 months while using only cannabis and psilocybin, but experienced a recurrence when she stopped self-medicating with these psychoactive drugs.

Sensational as this sounds, its important not to get carried away by a single case study or to jump to conclusions about whether or not weed and psychedelics were responsible for the patients remarkable recovery. Being an observational study, the report does not provide any biomedical analysis of the womans disease progression or treatment protocol.

The patient was first diagnosed with stage IV breast cancer in August 2018 and soon learned that the disease had spread to her bones, liver, and lymph nodes. She was immediately prescribed a course of chemotherapy and took the personal decision to begin self-treating with cannabis oil. From November of that year, the patient also underwent her first session of psychedelic therapy, ingesting a large dose of magic mushrooms under the supervision of a trained therapist.

Incredibly, scans conducted in January 2019 revealed that the cancer had completely vanished, with no evidence of residual or recurrent disease.

This highlights in the first phase of treatment the possibility of the therapeutic adjunctive effect of both psychedelics and cannabinoids in treating metastatic breast cancer, say the study authors.

Chemotherapy was subsequently stopped while the patient continued to take daily doses of cannabis oil plus magic mushroom microdoses. She also went a further three sessions of high-dose psychedelic therapy over the next two years.

Follow-up scans in September 2019 indicated that the cancer had not returned, at which point the patient reduced her cannabis intake to 56 percent of the initial dose while also temporarily halting the shrooms. However, further tests conducted in June 2020 revealed a recurrence of the disease.

This brings up the possibility that withdrawal of the cannabinoid and psychedelic therapies may have contributed to the return of the cancer, write the study authors.

Having received this news, the patient reintroduced psychedelics to her treatment regimen and boosted her cannabinoid ingestion. By October 2021, a stabilization of the illness was observed, although no details are provided as to the severity of the cancer at this stage.

Though the researchers are unable to explain how or indeed if this self-medication approach successfully arrested the patients cancer, they do point to pre-clinical studies hinting at the tumor-busting potential of both cannabis and psychedelics. For instance, research has shown that compounds in weed and magic mushrooms may inhibit a protein called Hypoxia-Inducible Factor (HIF)-1, which facilitates the development of blood vessels within tumors.

However, this has yet to be demonstrated in human cancer patients and there is no hard evidence that either cannabis or psychedelics have any direct impact on tumor development.

Nonetheless, the study authors conclude that the overall picture of the case presents the strong possibility that cannabinoids and psychedelics have played an important modulatory or additive role to standardized treatment, which warrants further exploration.

The study was published in the journal Drug Science.

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Ketamine, psilocybin and ecstasy are coming to the medicine cabinet – Yahoo Finance

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The formal lawns and topiary of the garden in which Amanda Feilding, Countess of Wemyss and March, is sitting embody a perfect English orderliness; beyond its edge lies a wilderness of Anglo-Saxon moats, sun-dappled woodland and magical stepping-stone trails. This promise of untamed hinterlands puts the grounds of Beckley Park in perfect sync with their mistress. Lady Wemyss is the queen of psychedelics.

Psychedelics have a history which is probably longer than that of civilisation. They have powerful effects on the brain and their lore is rich in anecdotes about effects on mental health, some for better and some for worse. As pharmaceutical companies tried to find new approaches to the brain, the potential of psychedelics might have seemed an obvious road to go down. But law and stigma blocked it. Until five years ago corporate investment in psychedelics as medicines was more or less unthinkable.

Work by Lady Wemysss Beckley Foundation, the Multidisciplinary Association for Psychedelic Studies (maps) in San Jose, California, and other such groups have helped to change that. So has the broadening acceptance of marijuana as a medicine and the softening or repeal of laws limiting its use. A change in the attitude of regulators and researchers towards running proper trials of the drugs has also contributed. Applying modern scientific techniques to the question of how psychedelics and other drugs affect the brain and mind is now seen as opening up possibilities for insight, treatment and profit.

The pioneer in this re-evaluation has been ketamine, an anaesthetic that is also used recreationally. About 20 years ago anecdotal evidence that the drug had an effect on depression led to academic trials; the work piqued the interest of j&j, a big drug company. The ketamine sold generically is a mixture of two compounds with the same chemical formula; j&j won a patent on a nasal spray called Spravato which contained just one of those compounds, s-ketamine. Americas Food and Drug Administration (fda) approved it as a treatment for major depression in 2019.

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Barefoot in the cross-head

Spravato demonstrated the potential of innovation based on recreational drugs: it was the first drug for depression based on a novel biological mechanism to have been approved in 30 years. But it has not been a big commercial success. It is expensive and has to be taken under medical supervision, which adds to costs and faff.

Despite that, all manner of drugs that were mooted as being psychiatrically beneficial in the 1960s are finally being put through their paces in rigorous clinical trials under the eyes of strict regulators like the fda. Dimethyltryptamine, ibogaine, lsd, mdma and psilocybin are being tried. These drugs are targeting the treatment of addiction, anxiety, depression, eating disorders and post-traumatic stress disorder (ptsd).

Within 24 hours of a single dose of psilocybin there was a 10% increase in the number of neuronal connections and some connections were stronger

The non-profit group maps is looking at mdma-assisted therapy for ptsd. mdma, widely known as ecstasy, is a small, amphetamine-like molecule prized for creating feelings of empathy. The maps trial put participants through three preparatory sessions, three sessions in which either mdma or a placebo was administered and nine post-treatment therapy sessions. At the end, 67% of participants in the mdma group no longer met the diagnostic criteria for ptsd, compared with 32% in the placebo group.

Psilocybin is a focus for compass Pathways, a London-based startup. Last year it published the results of a trial comparing different doses of psilocybin, all paired with therapy, in cases of treatment-resistant depression (trd). Three weeks after treatment 29% of those who got the highest dose were in remission.

Given what the tr in trd stands for, a response rate of almost 30% was exciting to scientists. But it was a disappointment to many who had been listening only to the media hype about the potential of psychedelics. The remission seen by fewer than one in three did not always last; only one in four were still in remission three months on. And three of the patients in the high-dose group displayed suicidal behaviour, compared with none in the other cohorts. Suicidality is common in trd and in trials of anti-depressants, but it is nonetheless a cause for concern.

One of the two underlying capabilities of psychedelics that interests researchers is that they seem to be able rapidly to induce neural plasticityphysical changes in the growth of neurons and of the connections between them. A recent study by scientists at the Yale University School of Medicine showed that, within 24 hours of a single dose of psilocybin, neurons in the prefrontal cortex of a mouse brain changed; their dendritesthe bits which receive inputs from their neighboursgrew longer and denser. There was a 10% increase in the number of neuronal connections and evidence that some of those connections were stronger.

Think of the neurons as close-packed trees flourishing in the lush gardens of the prefrontal cortex, which organises thoughts and actions. Dendrites are their tangled branches. A healthy brain has a rich canopy. Withered branches can lead to losses in connectivity and less communication between the context and areas associated with motivation and reward.

In the study, the connections between neurons in the mices brains became both more numerous and stronger, suggesting connectivity was improved. Not all the changes lasted; but a month later some were still visible. And they were correlated with changes in the animals stress-related behaviour.

The drugs trigger this sort of change in the neurons by activating various combinations of a specific set of receptor proteins which includes three types of serotonin receptor (5-ht1b, 5-ht2a and 5-ht2b) and nmda, a glutamate receptor. Different drugs favour different receptors (see diagram) which is why they have different effects. mdma, which produces psychedelic-like effects but without hallucinations, works on the 5-ht2 receptors, inducing a rapid release of serotonin and dopamine. Ketamine and ibogaine, which is extracted from an African shrub, both work on nmda as well as other receptorsincluding, in the case of ketamine, opioid receptors. The biochemistry of this is also linked to anatomy. Activation of 5-ht2ain which the visual cortex is comparatively richseems to be necessary (although not sufficient on its own) to generate hallucinations.

If plasticity is one interesting aspect of psychedelics, the other is that by firing up receptors they also disrupt activity within the brains neural networks. Srinivas Rao, the chief scientific officer of atai Life Sciences, a German company that specialises in psychiatric drugs, says the psychedelics and their kin are loosening connections in the brain and then altering network functions. Atai is pursuing ketamine for trd and ibogaine for opioid addiction.

Dr Rao warns that psychedelics are not going to be cures for most people with chronic conditions like depression. The loosening of connections in a network-disrupting trip might shift some of them out of a rut; it will not stop them returning to it. But many think the drugs open the door for talking therapies to work better and for patients themselves to initiate new approaches to life. A few patients will be lucky enough to have durable responses. Guy Goodwin of compass Pathways sees psychedelic treatment as a way for some patients to achieve a step change. It may be for a minority, he admits. How we increase that minority is a question we are going to have to work on in the future.

There are other factors which could limit the uptake of these medicines. Like Spravato they will probably be approved for use only in certified health-care settings and with strict protocols; a patient given a dose of psilocybin, or mdma, requires many hours of supervision. That makes these drugs very unlikely to be the first line of therapy offered to people who roll up at their doctors office with depression or anxiety. They are also likely to be approved for use only in the context of psychotherapy.

Such requirements may mean that more people seek the benefits more cheaply. The approval of Spravato coincided with an uptick in the use of generic ketamine, given by intravenous infusion, in clinics across America and Europe. And the drugs in question are all, more or less by definition, available informally.

Whos for a short, unstrange trip?

One alternative would be to develop second-generation drugs based on the same principles but more easily administered. Delix Therapeutics, based in Boston, Massachusetts, is heading full tilt to the creation of psychedelic substances with the hallucinatory effects eliminated, which would mean they could be used by patients without supervision. Dave Olsen, chief innovation officer at Delix, says the drugs work because they encourage neuroplasticity; if that is the case, then the trippiness may not be necessary. He points to studies showing that dental patients anaesthetised with ketamine wake up with an enhanced mood; having some kind of conscious experience is not integral to the drugs effects.

There will be potential patients who hope he is right. Some proponents of psychedelics think the mystical experience is integral to the clinical outcome, revealing insights into the psyche that are impossible to obtain any other way. This means they find it hard to bend their minds around the idea that some of the mentally unwell do not want to change their consciousness. They just want to get better. Rory, a hairdresser from Lancashire, had suffered from depression all his life; he had tried everything and was keen to find something that worked. Yet his first experience with a ketamine infusion was so horrendous he did not want to come back.

Delix, for its part, is not saying that the world does not need hallucinogens to treat mental-health disorders, nor that the network effects they offer are not useful. It is just saying that drugs that do only part of what psychedelics do could be useful in and of themselves. Dr Rao says, being empiric I view the hallucinations as a manifestation of network disruption.

Psychedelics are obviously not the be all and end all of new approaches to clinical neuroscience, let alone the one true path to raised consciousness and, as some would have it, humankinds continued evolution. They may well be particularly prone to placebo effects, something it is hard for trials to rule out since people tend to know if they have been given a placebo or sent on a trip. But if high hopes (sorry) seem likely to court disappointment, their study in clinical settings should yield some helpful therapeutic advances and new insights into the way minds sit in brains.

2022 The Economist Newspaper Limited. All rights reserved.

From The Economist, published under licence. The original content can be found on https://www.economist.com/technology-quarterly/2022/09/21/ketamine-psilocybin-and-ecstasy-are-coming-to-the-medicine-cabinet

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Ketamine, psilocybin and ecstasy are coming to the medicine cabinet - Yahoo Finance

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American Legion and Reality Center Partner to Provide Patented, Drug-Free Psychedelic Experience to Veter – Benzinga

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Santa Monica, California--(Newsfile Corp. - September 26, 2022) - American Legion Post 123 has officially partnered with Reality Mgmt Technologies (RMT) and its flagship facility Reality Center, located at the heart of Silicon Beach. This partnership will allow the Reality Center team to continue providing patented, drug-free psychedelic experiences to veterans in order to help treat post traumatic stress.

Since January of this year, the RMT team has successfully treated more than 200 veterans suffering from PTS at their new, state-of-the-art sensory wellness center and digital therapeutics lab only steps away from the Santa Monica Pier. These treatments have earned the interest of their local VSO, American Legion Post 123 in Santa Monica,as they became aware of the treatments Reality Center was already offering some of their members.

"Post 123 is committed to integrating our community of veterans with the rapidly growing wellness ecosystem here in Santa Monica," stated Post Commander Bailey Steele. Since partnering, the local American Legion post has been offering free monthly treatments to their members as a way to increase their post 9/11 veteran membership and promote their focus on a new mental health ecosystem.

Reality Center's patented tech and modalities work by combining ancient and modern science. They are able to address a wide array of mental, physical and emotional issues in a one-of-a-kind healing environment. Providing a safe and effective alternative to psychedelics and pharmaceuticals, Reality Center provides a controlled, drug-free experience using frequency technologies to stimulate the nervous system's natural healing mechanisms.

The main treatment veterans experience include Reality Center's most popular offering which involves having each veteran lay on a vibrational platform or liquid mineral bed for 30 minutes while experiencing pulsing lights and synchronized sounds that allow individuals to immediately exit fight or flight and journey deep into their consciousness.

PR Contact: Sharon FoxEmail:sfox@realitymgmt.com

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138445

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