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Category Archives: Psychedelics

Will Psychedelics Be Rescheduled After FDA Approval? – Harris Bricken

Posted: July 19, 2023 at 1:15 pm

A handful of entities are in various stages of the FDA approval process for MDMA and psilocybin drugs (seehereandhere for some of our prior analysis of the issues). FDA approval could happen in the next few years.

But theres a catch: psilocybin and MDMA are both schedule I drugs under the Controlled Substances Act (CSA). And schedule I narcotics are essentially off limits for prescription. So, how will this new system work?

In order for physicians and medical professionals to prescribe and administer FDA approved MDMA and psilocybin formulations, the federal government has to reschedule them. One question I get frequently is whether this would mean a categorical rescheduling of MDMA and psilocybin. In other words, would the government move psilocybin and MDMA, as a whole, to a lower schedule.

The answer to this question is almost certainly no. In all likelihood, the federal government will reschedule the FDA approved drug formulations and leave MDMA and psilocybin on schedule I. There is precedent for this. Gamma-hydroxybutyric acid (or GHB) is a schedule I depressant under the CSA. Drug manufacturers have gotten FDA approval for drugs that contain formulations of GHB for example, XYWAV, and according to that link:

XYWAV is a Schedule III controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

Indeed, if you take a look at the DEAs CSA regulations, youll see right there under schedule III: Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. Translated into English: if a drug containing GHB gets FDA approval, it is a schedule III drug.

All signs point to something similar happening for both MDMA and psilocybin. Theres virtually no way the federal government will loosen up CSA restrictions for non-approved formulations, so well likely see carveouts for those FDA approved drugs on schedule II or III. That will allow a regulated medical market while giving the DEA wide enforcement powers for everyone else.

I should also point out here that the expected rescheduling wont effect the service center market in places like Oregon or Colorado. Those service centers will use psilocybin produced in state-regulated manners, not FDA approved formulations. So none of the benefits of, say, moving a drug to schedule III and getting rid of 280E risks, are going to happen.

Make sure to stay tuned to the Psychedelics Law Blogfor more updates on the psychedelics industry.

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The Psychedelic Preparedness Scale: A Tool to Optimize Trip … – Filter

Posted: at 1:15 pm

The journey itself is only one part of the psychedelic experience. But while many people are now recognizing the need for integrationprocessing, interpreting and incorporating what happened during your tripfewer are focused on what happens before it starts.

Preparation is just as crucial as integration, if not more so, believes Rosalind McAlpine, a PhD candidate at University College London. Most studies and trials include a preparation stage, but there are no established standards for what that entails, and the people designing and leading research often dont have firsthand experience. Its why she helped create the first Psychedelic Preparedness Scale (PPS): Based on feedback from people who actually use psychedelics, it measures the degree to which a person is prepared for a trip.

In societies where plant medicine is part of everyday life, many aspects of what we might call preparedness are often woven into the fabric of the culture, and the community itself acts as a container, McAlpine told Filter. But in the Global North, this is a relatively new construct [and] theres an active need to make time and space for adequate preparation.

Anything we can do before going in to increase the likelihood of having a safe, meaningful and potentially transformative experience should be exposed.

In a presentation at Breaking Convention 2023, she likened it to a day trip to Paris: You dont have to pack, research, or plan a route; youll still have an experience. But youll probably end up missing a lot of what you hoped to encounter, and you might even end up in an unsafe situation.

Psychedelics, too, will bring you an experience no matter whatbut without familiarizing yourself with the possibilities, you could not only miss the benefits, but potentially suffer real harms.

Challenging experiences are often the most transformative parts of psychedelic journeys, but these can be incredibly intense: from encounters with death or otherworldly entities, to repressed memories resurfacing. People need tools to navigate these moments when they arise.

Blogs and articles provide blanket advice; retreat centers give attendees guidelines; but none of this is standardized or geared toward the clinical setting, and little of what users and practitioners are doing is documented, McAlpine said.

The PPS aims to change that. From the perspective of harm reduction, she said, anything we can do before going in to increase the likelihood of having a safe, meaningful and potentially transformative experience, reducing the risks involved and potentiating challenging experiences as growth opportunities rather than traumatic events should be exposed.

The team gathered items for the scale based on feedback from both learned experience experts and lived experience experts.

McAlpines team defines psychedelic preparedness as a state preceding the session that is conducive to a safe and personally meaningful experience. The state will allow the participant to be psychologically, physically, and socially ready for the content and consequences of the experience, and will most likely involve a variety of extra-pharmacological factors.

The team gathered items for the scale based on feedback from both learned experience experts in psychiatry, philosophy and psychedelic research and, uniquely, lived experience experts undergoing psychedelic healing, whose perspective is often missing from scientific literature.

The intention was to include patient and public involvement [or PPI], throughout the whole process, McAlpine said, from creating the scale to implementing and optimizing it, in order to reflect not only the rigorous, hard-science framework, but also the voices of those people who would most benefit. PPI aims to bring accountability, transparency, and relevance to scientific studiesdefined by the authors of a paper that inspired the team as research performed with or by patients and members of the public, rather than to, about, or for them.

The scale was built in a three-study process. This involved collecting feedback through focus groups and interviews to determine which measures should be included; exploratory and confirmatory factor analyses to gauge which measures most impacted preparedness; and preliminary implementation. The scale was then validated by two online samples of psychedelics users (516 and 716 people, respectively), and tested on 46 people attending psilocybin retreats at partnering centers, tracking preparedness levels and outcomes.

Preparedness elements defined by the PPS fall into four categories. These include knowledge expectations, meaning the person had an understanding of the substance itself and what the experience might be like; support and planning, meaning they felt the substance was safe to take and had a supportive physical environment; and psychophysical readiness, or being prepared for the whole range of emotional experiences, from bliss to horror, as well as physical possibilities, like vomiting or urination.

Across the board, participants with higher levels of preparedness had significantly better outcomes than those with lower levels.

The final category was intention preparation, involving measures like journaling, breathwork, and meditationrated most important by participants. McAlpines team plans to pilot a meditation-based preparedness intervention at UCL.

Through meditation, one participant said, I was able to enter the psychedelic state with a more open and receptive mindset. It helped me shed some of my preconceptions and allow the experience to unfold organically, without trying to control it or impose my own expectations.

Another noted, [Meditation] allowed me to approach the experience with a sense of curiosity and exploration, rather than fear or resistance.

Measures of participants outcomes included emotional breakthrough; mystical experience; challenging experience; post-psychedelic growth; the centrality of the event (whether, and how, the experience became central to their identity and a turning or reference point for their life story); wellbeing; relationship attachment style; extraversion; altered states of consciousness (gauging the acute experience); and depression, anxiety, and stress.

The scale doesnt prevent difficult things from happening, but it can point you in the right direction to reduce harm and maximize benefit.

Across the board, participants with higher levels of preparedness had significantly better outcomes than those with lower levels. High preparers had higher scores on positive measures such as unity, spiritual experience, blissful state, and insightfulness than low preparers; they also showed significantly greater reductions in depression, anxiety, and stress. When high preparers did have challenging moments in a trip, they were more likely to turn them into growth opportunities, and they were also more likely to experience positive changes in wellbeing after the experience.

The scale doesnt prevent difficult things from happening, but it can point you in the right direction to reduce harm and maximize benefit, McAlpine said. If one went into those experiences with no idea that was going to happen, it can be an unnecessary challenge Even a little bit of psychoeducation [and] expectation management can go incredibly far.

The PPS could serve as a valuable screening tool to identify individuals who may require additional preparation or support prior to undergoing psychedelic interventions, thereby functioning as a pre-intervention assessment to pinpoint areas of preparedness that necessitate attention, the researchers wrote. Furthermore, the PPS could serve as an outcome measure to evaluate the effectiveness of psychedelic preparedness interventions or to compare the efficacy of different preparation protocols.

Just because a study is conducted in a scientific setting doesnt mean its safe, as evidenced by allegations of abuse and misconduct in some of the MDMA trials conducted by MAPS. There needs to be more investigation and reporting of whats going on in those preparation sessions, specifically within the context of clinical psychedelic-assisted psychotherapy, McAlpine said.

While the PPS was co-created with people who use psychedelics, the studies behind it focused on clinical settings, limiting researchers to including only people who could legally disclose their psychedelic usethose who had participated in research studies, clinical trials, or retreats. (Only clinical-trial participants contributed to the creation of the scale items.)

The last thing we want is to be like, Were the scientists, were right.

Obviously, this misses a massive swath of the user base, as McAlpine lamented, and vastly underrepresents the Indigenous people who are the original keepers of the largest body of knowledge on the subject. It also impacts the demographic makeup of their samples: The academic contributors, unsurprisingly, were predominantly white men. The lived-experience experts were more diverse by gender and nationality (data on sexual and gender identity were not collected). But respondents were still largely white, educated and well-off, hailing from the United Kingdom (mostly) and other European countries.

The PPS is open-access, and McAlpine encourages everyone to use it. She now calls upon others to pick up where her teams research left off, capturing a broader scope of lived experience. The scale is currently being used in a DMT neuroimaging study at University College London, and organizations such as the Institute of Psychedelic Therapy have used it for therapist training.

The aim is to keep it iterative and intuitive, learning from as many sources as possible to shed light on what works and what doesnt, McAlpine said, [while] giving voice to people who dont always get it. The last thing we want is to be like, Were the scientists, were right.

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How to Test Psychedelics for Adulterants with Testing Kits – Psychedelic Spotlight

Posted: at 1:15 pm

As interest in psychedelic substances grows, ensuring the safety and purity of these substances is an increasingly important thing to practice. One of the most effective ways to mitigate risks associated with drug use is through the use of testing kits. Organizations like DanceSafe.org offer testing kits that allow individuals to analyze the composition of various psychedelic drugs, helping identify potential adulterants or contaminants.

Before delving into the specifics of testing various psychedelic drugs, it is essential to comprehend the purpose and benefits of testing kits. These kits are designed to provide users with crucial information about the contents of a particular substance. By analyzing the presence of adulterants, such as harmful chemicals or other drugs, testing kits help individuals make informed decisions and reduce the risks associated with substance use.

Testing your psychedelics is very easy and only takes 5 minutes. You should never skip testing your psychedelics, specially if buying from strangers or new dealers. Even if you have a reputable seller, always test your drugs, as you never know if their supply has changed.

If you are afraid that testing your drugs will be expensive, fear not. Testing kits are affordable. The LSD and ketamine kits are only $20 each, while the MDMA one is $50 (since it includes 3 reagents). Plus, each kit can perform between 50-75 tests. That should be enough to last you a long while.

To begin testing a psychedelic substance for adulterants, it is important to choose a suitable testing kit. DanceSafe.org is a reputable organization that offers a range of testing kits specifically designed for different types of substances which has become drug users favorite go-to brand. Their kits often utilize reagent tests, which involve adding small amounts of the substance being tested to a reagent chemical and observing color reactions to determine its composition. Additionally, DanceSafe.org provides detailed instructions and resources on how to use their testing kits effectively. (This is not a sponsored post. They are just the most popular, affordable testing kit manufacturer).

There are different types of reagent tests that can be utilized for testing a variety of drugs. The common reagent tests you can find are: Marquis, Simons, Froehde, Liebermann, Morris, Ehrlichs, Mandelin, Mecke, and Folin. Lets break down what the purpose of each is. Each link will take you to the corresponding kit page on DanceSafe.

Marquis: The Marquis reagent is a reagent that is used to test for the purity of MDMA and cocaine. It effectively reacts with amphetamines. The Marquis reagent cannot be used alone and should be with at least another reagent to confirm the purity of a substance. It is the first step in testing MDMA and second step in testing cocaine.

Simons: This is a secondary test that is almost always used alongside another reagent for confirmation. It is one of the three reagents used to test MDMA. Simons helps differentiate between MDMA and MDA, as well as methamphetamine and amphetamine.

Froehde: This is a reagent also used in testing MDMA but can produce unique color reactions with substances such as 2C-B, mescaline, and some cathinones.

Liebermann: This reagent is helpful for identifying possible cocaine adulterants like levamisole. It is also useful for testing substances like amphetamines, ketamine, and more unusual drugs.

Morris: This testing kit that can distinguish ketamine from DCK, 2-FDCK, and other novel dissociatives. It can also be used to determine the presence of cocaine.

Ehrlichs: This reagent is used to test the purity of LSD to ensure it is not adulterated with substances like 25I-NBOMe.

Mandelin: The Mandelin reagent is used as an additional layer of testing for a variety of drugs. This test provides more information when other reagents do not go as expected. It can react with amphetamines, certain cathinones, cocaine, ketamine, 2C-B, 2C-I, mescaline, PMA, PMMA, oxycodone, heroin, aspirin, and sugar.

Mecke: Similar to the Mandelin reagent, the Mecke test is used to perform more specialized and complete testing. It can help confirm the identity of substances such as entactogens, cathinones, 2C-B, 2C-I, mescaline, oxycodone, heroin, and sugar.

Folin: This last reagent is useful for detecting a class of drugs called piperazines, which include BZP and TFMPP.

LSD is commonly sold on blotter paper or in liquid form. To test LSD for adulterants, carefully cut a small portion of the blotter or gel tab and place it on a white, ceramic plate. It is important that it is white, as it will facilitate seeing the color.

Candies, purple- or blue-dyed blotters, and gel tabs can be difficult to test. Although sometimes possible, the reaction can be hard to read. Gel tabs may take longer to dissolve.

Hold the reagent bottle an inch or two above the sample and squeeze one drop of Ehrlichs reagent, and observe the color reaction over the next five minutes. A violet hue indicates the presence of LSD. Once you observe the color reaction, dispose of the small piece of the blotter. Do not consume a tested blotter. Consuming Ehrlichs reagent can be fatal.

If Ehrlichs doesnt turn purple, you definitely do not have LSD. Drugs like 25I-NBOMe do not react with Ehrlich, so it is possible the LSD sample is adulterated. Do not consume an adulterated LSD tab.

If Ehrlichs turns purple, there is a high chance you have LSD. It may be reacting with another indole, but you are not getting an immediate red flag that something is wrong.

LSD will show up purple on an Ehrlich's reagent test. No reaction indicates an adulterated substance. Source: DanceSafe

MDMA is often found in pill or powdered form. To test MDMA, you will require three different reagents: Marquis, Simons, and Froedhe. All three are required for a comprehensive analysis of the sample. To test MDMA, scrape a small amount of the pill or powder onto a testing plate. You will need enough for three different reactions.

Place a drop of the marquis reagent on your MDMA sample. In the presence of MDMA, Marquis will quickly turn black, or you will see purple at first.

This step will help you differentiate between MDMA and MDA. Simons turns blue in the presence of MDMA and will not react or turn a dark grey with a hint of green in the presence of MDA. Place a drop on another clean sample.

Lastly, this step will help test for the very rare occasion that you were sold drugs called APBs under the guise of MDMA. This reagent is most useful for testing something that was sold to to you as an APB. It can be hard to differentiate between an MDMA/MDA reaction and an APB reaction, so do not assume you have an APB reaction unless theres very, very clear purple in it. Pleace a drop on another clean sample. Do not test on previously tested samples.

Ketamine has risen in popularity in the past couple of years, especially in the club, rave, and gay scenes. With more demand for ketamine, there is the possibility of manufacturers cutting corners and adulterating it to reduce costs. There are an increasing number of drugs that are being sold under the guise of ketamine presently, and these can include ketamine analogs, PCP analogs, novel dissociatives. Because ketamine is often sold in a white powder form, it is also possible it can be adulterated with cocaine or fentanyl. To test for ketamine, Morris reagent is used. Other tests can be used to further analyze the drug such as those testing for cocaine or fentanyl. The Morris reagent is a two-part process that comes in two bottles: a pink one (Morris A) and a green one (Morris B)

Use at least 5-10mg of material to get an accurate reading. On a white ceramic plate, put a drop of the pink bottle (Morris A) that comes with the Morris testing kit onto your sample.

Put a drop of the green bottle (Morris B) on the same sample. The sample should have both Morris A and Morris B on it.

Using a toothpick or the sharp point of a knife, stir the mixture for a full 30 seconds.

A ketamine sample will turn purple. Cocaine will turn bright blue, like a Jolly Rancher. DCK or 2F-DCK will turn dark blue/gray. Most other drugs will turn a dull green, meaning a negative reaction.

It is important to learn how to read a ketamine test to be sure of the authenticity of your substance. Source: DanceSafe

While shrooms do containe indole groups, Ehrlichs reagent is not recommended to be used with them, as it is only meant to test LSD. There are no current reagents that test shrooms for adulterants.

The most important harm reduction practice is triple checking that you actually bought psychedelic mushrooms and are not being sold poisonous mushrooms.

If you personally harvested mushrooms in the wild, it is very important to get them identified by a professional mycologist group, forum, individual, or association especially if you do not have much experience with foraging wild mushrooms. Galerina is a genus of mushrooms that are commonly misidentified as shrooms; this genus contains some extremely poisonous species. Identifying mushrooms is not as easy as one may think, so only do so, if you are 100% sure of your skills. Ingesting a wrongly-identified mushroom can lead to serious health consequences or death.

If you are growing mushrooms at home, ensure that the spore vendor where you bought your spores from is reputable. Do your due diligence and ask around psychedelic communities for their opinion on a vendor you are thinking of using, as many people may have had experiences with them or know of a better vendor.

Although rare, there have been instances where fentanyl has been found in certain psychedelics, such as ketamine. While there are no testing strips on the market that can detect every fentanyl analog, using a strip is still good practice to detect the presence of any analog. You can test for fentanyl on any LSD, MDMA, ketamine, cocaine, pharmaceuticals, and more.

To test for fentanyl in a sample, simply dilute a sample of the drug in water. The ratio of powder to water is 10mg / ml. Dip the testing strip in. If the testing strip has two red lines, it has no fentanyl. If it has one red line, it has fentanyl.

Do not skip on testing your substances. Responsible drug use requires testing substances every time before consuming them. Always test your drugs, even if you bought them from the same seller multiple times in the past without problems. Drug dealers may change the distributor where they get their drugs from, or may be unaware where they come from. Some drug dealers test your drugs for you and show you the results of the reagent tests before selling them, but this is not common practice.

In public spaces like concerts and festivals, it is more common for people to take drugs without testing them. It is good practice to bring a testing kit with you it only takes 5 minutes of your time. Some festivals also bring harm reduction and testing organizations to their grounds to help festival goers test their drugs, and no, the police will not get you because you use them. These organizations are there to help you.

It is also common for harm reduction organizations to exist in your city. It is more than likely that someone in your city has started a harm reduction service. There are syringe exchange programs, mobile harm reduction testing sites, and harm reduction hotlines that are available to you to test your drugs, in the case you do not want to do it yourself at home.

Do not feel pressured to take drugs you arent sure of, and always suggest testing them. Doing so helps break down stigma surrounding drug testing, too. And do not fall victim to the mindset of oh, but Im wasting product by testing. Only a minimal amount is required to test a drug, and it is better off losing milligrams of your product than losing function of your body or even losing your life.

It is crucial to remember that testing kits provide preliminary information and are not infallible. While reagent tests can detect the presence of specific substances, they cannot identify all potential contaminants. Additionally, different adulterants may produce similar color reactions, requiring further testing or professional lab analysis for confirmation. Therefore, if there is any uncertainty about the results, it is advisable to err on the side of caution and refrain from consuming the substance.

Testing kits provided by organizations like DanceSafe.org play a vital role in promoting personal safety and harm reduction within the realm of psychedelic drug use. By utilizing these kits and following proper testing procedures, individuals can gain valuable insights into the composition of their substances, helping them make informed decisions about their own well-being. Part of being a person who uses drugs is responsibly doing said drugs. It is crucial to prioritize personal safety, education, and responsible drug use practices to minimize potential risks associated with psychedelic substances.

Psychedelic Spotlight's Bonfire division offers aFREE Psychedelics for Beginners coursewhere you can learn everything about the different psychedelic compounds, the importance of mindset, how to prepare for your psychedelic experience and how to integrate it.

Disclaimer: Psychedelic Spotlight does not condone the use of illegal substances. The purpose of this article is for educational and harm reduction purposes only. If you suffer from a medical or mental condition, please consult with your doctor before taking any substance.

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Cannabis Science Conference to debut in Providence, R.I., with … – GlobeNewswire

Posted: at 1:15 pm

PROVIDENCE, R.I., July 18, 2023 (GLOBE NEWSWIRE) -- Cannabis Science Conference (CSC), the premier cannabis science conference focusing on analytical science, medical cannabis, cultivation and psychedelics, announced today that its fall edition will make its first-ever appearance in Providence, R.I. Taking place at the Rhode Island Convention Center from September 2022, this highly anticipated conference will become the epicenter for education related to the exciting cannabis and psychedelic markets.

We are thrilled to bring the Cannabis Science Conference to Providence, said Megan LHeureux, group editorial director of Cannabis Science and Technology and Cannabis Patient Care magazines. Rhode Island is emerging as a major player in the cannabis science industry, and this event will serve as a dynamic hub for professionals to learn, network and collaborate.

Keynote speaker Dr. Peter Grinspoon, a primary care doctor at Massachusetts General Hospital, instructor in medicine at Harvard Medical School, and 25-year cannabis specialist, will share his knowledge in an address titled, Cannabis Reconsidered: A Science-Based Look at the True Harms and Benefits. In a recent interview with Cannabis Science and Technology, Grinspoon discussed what he hoped attendees will learn from this presentation. We all need to be humble. We all need to forget what we think we know about cannabis. Nobody, including me, has a monopoly on the truth. We just have to think for ourselves, said Dr. Grinspoon. I'm just really hoping that by challenging some of the myths, methodology, and misconceptions that people will come away feeling more confident in thinking for themselves on this issue.

Dr. Dustin Sulak, a distinguished integrative medicine physician, will also take the stage at the fall event for a keynote address. With a deep-rooted practice in osteopathy, mind-body medicine and medical cannabis applications, Dr. Sulak is renowned for his expertise in the medical use of cannabis. His keynote address, The Knowledge and Art of Combining Cannabinoids for Treatment Success, will explore recent advancements in accessing rare cannabinoids and challenge assumptions about THC and CBD combinations. CSC will also feature several fireside chats with industry experts such as world-renowned cannabis geneticist Adam Jacques as well as a hot button discussion on THC potency inflation with leading analytical scientists.

CSC is designed to provide world-class science education and insights. Attendees can expect expert-led presentations, roundtable discussions, exhibits and a full-day pre-conference workshop called Canna Boot Camp, taking place on September 20. Canna Boot Camp covers a wide range of cannabis science topics, including cultivation, preprocessing, sample preparation, analytical testing, extraction and edibles manufacturing.

The conference boasts dedicated program chairs and an educational steering committee, ensuring the highest quality and relevant content. CSC places great emphasis on networking and collaboration opportunities among attendees, speakers and exhibitors, fostering a vibrant atmosphere for knowledge exchange and business growth within the cannabis industry.

To register and learn more, please visit the registration page.

About Cannabis Science Conference:

Cannabis Science Conference (CSC) is the industrys premier science event, focusing on analytical science, medical cannabis, cultivation and psychedelics. CSC brings together cannabis and psychedelicindustry experts, including instrument manufacturers, testing labs, research scientists, cultivators, medical practitioners, policy makers, patients and interested novices to network and share ideas. CSC runs semiannual events nationwide in emerging markets, aimed at improving cannabis and psychedelic science. Join us for world-class education, stellar networking and the opportunity to connect with thought leaders, leading scientists, pioneers in cutting-edge medical applications and industry suppliers. For more information, visitwww.cannabisscienceconference.com.

Media Contact: Lauren Garafola MJH Life Sciences lgarafola@mjhlifesciences.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0392bfc7-563b-4b86-bd0d-9e70982b71a3

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New Speaker Rivas weighs in on psychedelics, housing and health care worker minimum wage – Yahoo News

Posted: at 1:15 pm

Good morning and welcome to the A.M. Alert!

RIVAS SAYS YES TO THREE CONTROVERSIAL BILLS

Via Mathew Miranda

Speaker of the Assembly Robert Rivas supports legalizing psychedelic drugs, raising health care worker minimum wage to $25 and a controversial housing bill opposed by some Assembly Democrats and the San Francisco Giants.

He doled out those opinions, plus more on his leadership plans and priorities for a new era in the California Legislature, at the Sacramento Press Club on Wednesday.

The housing bill, introduced by Sen. Scott Wiener, D-San Francisco, passed the Assembly Committee on Natural Resources despite the chairs opposition on Monday. It extends an existing law that allows streamlining of multifamily housing developments in cities that arent meeting state-mandated requirements.

Im excited to support any and all efforts to ensure that well get a good policy across, Rivas said.

Wiener is also pushing for SB 58 to decriminalize psilocybin (magic mushrooms), psilocyn, DMT, mescaline and ibogaine. The bill passed its final policy committee on Tuesday, and now advances to the Assembly Appropriations Committee. This marks the San Francisco Democrats second bid to remove criminal penalties for possession and personal use of certain psychedelics.

Rivas said yes, when asked if California should legalize psychedelics.

As for the proposed minimum wage increase, Rivas paused for 10 seconds before saying I want to be respectful of the process, yes.

NEWSOM STUMPS FOR MENTAL HEALTH BOND ISSUE

Via Maggie Angst...

With budget negotiations in the rearview mirror, Gov. Gavin Newsom is turning his attention to the next priority -- securing legislative and voter approval of his multi-billion-dollar plan to house thousands of mentally ill people across California.

Newsom held a roundtable Wednesday with state and local lawmakers and behavioral health advocates to drum up support for a proposed ballot measure that he says will help the state treat brain health early before we punish it later.

Story continues

There is no other issue that impacts more people in more ways on more days than the issue of behavioral health, the issue of mental health, Newsom said during a press briefing afterward.

A pair of bills from Sen. Susan Talamantes Eggman, D-Stockton, and Assembly Member Jacqui Irwin, D-Thousand Oaks, that would enact the governors plans are making their way through the legislature.

Irwins calls for using $4.68 billion in new bond revenue to build 10,000 new mental health treatment beds. Eggmans would reform the states Mental Health Services Act, passed by voters as Proposition 63 nearly 20 years ago and used by counties to fund services for residents with serious mental health issues.

Newsoms vision is to combine the two bills into one ballot measure that would go before voters in March 2024. But first, two-thirds of lawmakers need to vote in support.

OPIOID OVERDOSE PREDICTIONS....FOR 2022

Via Gillian Brassil...

It sounds a bit odd to predict something for a year thats come and gone. But thats what the Centers for Disease Control says about opioid deaths nationwide in 2022. They stayed flat, although California is among the states where cases are still expected to have risen.

The data is predictive to adjust for incomplete reporting. Drug overdose deaths are often initially reported without a cause because they require lengthy investigation

The latest report predicts fewer than 110,000 overdose deaths for the year ending in Feb. 2023, with most caused by illicit synthetic drugs like fentanyl. Still, CDC data predicts that California cases will rise year over year by about 200 cases to roughly 12,200 deaths. It is among the half of states predicted to increase rather than decrease.

Overdose deaths had been rapidly increasing since 2019, the onset of the coronavirus pandemic. About 69,000 deaths were suspected for the year ending in Feb. 2019, ballooning to over 110,000 in the year ending in Feb. 2022.

Dr. Rahul Gupta, director of the White House Office of National Drug Control Policy, said the data shows our nation is finally seeing early indications of success in the overdose rate that we must sustain with even more urgent action.

Tackling the opioid epidemic has been a Biden administration priority. This week, the White House announced a plan to curb the spread of a powerful veterinary tranquilizer, xylazine, that is being combined with illicit fentanyl.

Gov. Gavin Newsom too has made cracking down on fentanyl a priority, launching a partnership between the state and San Francisco to seize illicit drugs and approving $30 million for making its own naloxone from settlements with opioid manufacturers.

Naloxone can reduce or reverse effects of an opioid overdose. If you think someone is having an overdose, the California Department of Public Health recommends the following:

Call 911 and give naloxone.

Keep the person awake and breathing.

Lay the person on their side to prevent choking.

Stay with the person until 911 responders arrive.

QUOTE OF THE DAY

The best place for Mexican food in Sacramento? Laurel Rosenhall asked Robert Rivas at the Sacramento Press Club.

(long pause)

Really? Assemblywoman Sharon Quirk-Silvas house he responded.

Best of The Bee:

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TDR’s Top 5 Psychedelic Developments For The Week Of July 10 – The Dales Report

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Welcome to TDRs review of the Top 5 Psychedelic Developments for the week of July 10. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Ketamine For Severe Depression: 1 In 5 Achieve Remission After A Month In Promising Aussie Trial

A month-long course of ketamine injections may be an effective treatment for severe depression, say Australian doctors who found promising remission rates in their largest-of-its-kind trial.

One in five adults in the Ketamine for Adult Depression Study (KADS) achieved total remission from their symptoms after a month of twice-weekly subcutaneous ketamine injections, reported the UNSW Sydneyled team.And nearly a third of the 179 participants in the placebo-controlled trial had a 50% reduction in symptom severity.

However, these benefits disappeared after treatment cessation, which the researchers said suggested a need for longer-term treatment to maintain the antidepressant effects.

4. Tryp Therapeutics Receives Confirmation From FDA To Proceed With Phase 2A Clinical Trial in Patients With IBS

Tryp Therapeutics has received confirmation from the U.S. Food and Drug Administration (FDA) that its review of Tryps Investigational New Drug (IND) #163,994 is complete and that the company may proceed with its Phase 2a clinical trial at Massachusetts General Hospital investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS).

The planned study in collaboration with Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain which will be measured at four weeks post the final therapist-monitored psychedelic drug session, along with numerous other secondary endpoints including changes in brain connectivity.

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More Than6 in 10American Registered Voters Support Legalizing Regulated Therapeutic Access To Psychedelics35%Indicate Strong Support

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3. Psychedelic Stocks Pause, Underperforming Peer Biotech Indices

After a strong double-digit run last week, the psychedelic sector took pause, as reflected by theAdvisorshares Psychedelics ETF (PSIL)0.97%. The performance lagged biopharma peers indices such as theNasdaq Junior Biotechnology Index3.58%andNasdaq Biotechnology Ishares ETF3.18%which both rose moderately. TheNASDAQ 1003.37%andS&P 5002.28%also rebounded on the back of a falling consumer price index print.

Heres how the Health Care (Biotechnology) sector performed:

In the news

Beckley Retreats has extended its strategic partnerships with the Heroic Hearts Project and Imperial College London.

Berkeley, California City Council has approved a resolution todeprioritize the enforcement of laws prohibiting psychedelics.

BetterLife Pharm highlighted the American College of Physicians guidelines for the treatment of Major Depressive Disorder published recently in Annals of Internal Medicine.

Bipartisan congressional lawmakers are celebrating the inclusion of a psychedelics research amendment as part of a must-pass defense bill thats on the House floor.

Bipartisan lawmakers pushed for the adoption of marijuana and psychedelics amendments as part of a large-scale defense bill at a House committee meeting on Tuesdaybut the proposals fate remains uncertain following complications over unrelated measures being pushed by conservative members.

Bright Minds Biosciences announced that, further to its news release on June 22, 2023, the Company will consolidate its common shares on a five (5) to one (1) basis.

CybinInc. has commenced the development of a streamlined, scalable version of its EMBARK Training Program, known as EMBARK.

Denver Post expects psilocybin therapy to come sooner rather than later

Drug Science to launch first study to directly test molecular neuroplasticity effects of DMT in humans.

Lucy Scientific Discovery announced the launch of Twilight a blend of Amanita and Reishi mushrooms that include a variety of other nootropics promoting improved cognitive function and enhanced sleep quality.

Lucy Scientific Discovery has appointed Richard Nanula, former CFO at Amgen Inc. and The Walt Disney Co. as its new CEO.

Massachusetts: Political strategists have quietly filed paperwork to put a therapeutic psychedelics legalization initiative on the states 2024 ballot.

Meme Of The Week

New study by leading academics in the psychedelics space finds that psilocybin combined with therapy could be more cost-effective at treating major depression disorders than currently used methods.

New study reveals distinct effects of excitalopram (Lexapro) and psilocybin on brain responses to emotions, highlighting the unique approaches of these treatments in addressing depression.

Psilocybin dispensary crackdown in Windsor, Ontario.

Psycheceutical Bioscience has dosed the first healthy volunteer in a Phase I trial investigating a topical administration of ketamine for the treatment of post-traumatic stress disorder (PTSD)

PsyenceGroup announced the appointment of Christopher Bull to the board of directors of the Company effective immediately.

Public awareness about psychedelics is growing, but more needs to be done

OUT NOW: The results of the inaugural UC Berkeley Psychedelics Survey

47% of all respondents have heard about psychedelics recently 48% of those respondents associate psychedelics with mental health

Explore the data here: https://t.co/IzPJi2oITl pic.twitter.com/HtWn2k97N4

Rep. Dan Crenshaw again pleaded his case for the advancement of psychedelic use in the mentally ill. The matter at hand pertains to a critical Bill that aimed to utilize and study psychedelic treatments for mental illnesses in conjunction with theDepartment of Defense.

Three people associated with an illegal magic mushroom dispensary in London, Ont. were charged with drug related offences more than a month ago.

UC San Diego Psychedelics and Health Research Initiative received a $1.5 million gift from philanthropist Eugene Jhong to further our understanding of the unique states of consciousness induced by DMT and how it could benefit human health.

West Hollywood will host a free Community Educational Forumabout the possible state-level decriminalization of mushrooms (Psilocybin) and certain hallucinogenic drugs.

2. Majority Of U.S. Voters Support Therapeutic Use Of Psychedelic Drugs

Most U.S. voters support legalizing psychedelics for therapeutic use, and a growing proportion of people who report using psychedelics are microdosing taking tiny amounts of the drugs and using them for therapeutic purposes, according to a survey released Wednesday by the UC Berkeley Center for the Science of Psychedelics.

Sixty-one percent of people say they would support creating a regulated legal framework for the therapeutic use of psychedelics, according to the survey, which polled 1,500 registered voters online and over the phone June 9-15.

A slim majority, 56%, also say they would support federal regulators approving the use of psychedelics for prescription use.

1. California Health Committee Votes 9 To 2 To Legalize Psilocybin, DMT And Ibogaine

A second California Assembly committee has approved a Senate-passed bill to legalize the possession and facilitated use of certain psychedelics, bringing it one step closer to the floor.

Another California Assembly Committee Approves Senate-Passed Psychedelics Legalization: The sponsor said last month that the bill wasup against a challenging road toward passage but has now cleared a major hurdle.https://t.co/6MOvfammnO

The legislation from Sen. Scott Wiener (D) advanced through the Assembly Health Committee in a 9-2 vote on Tuesday. This comes about two weeks after it wasapproved by the Public Safety Committeeand two months after itcleared the full Senate. The measure must now go to the Appropriations Committee before potentially moving to the floor.

Tuesdays vote is a welcome development for advocates, as Wiener said last month that the bill wasup against a challenging road toward passagegiven its referral to the Health Committee, where the chances of approval were less certain.

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TDR's Top 5 Psychedelic Developments For The Week Of July 10 - The Dales Report

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Psychedelic Treatment with Psilocybin Relieves Major Depression, Study …

Posted: February 20, 2023 at 1:17 pm

A compound found in so-called magic mushrooms, psilocybin produces visual and auditory hallucinations and profound changes in consciousness over a few hours after ingestion. In 2016, Johns Hopkins Medicine researchers first reported that treatment with psilocybin under psychologically supported conditions significantly relieved existential anxiety and depression in people with a life-threatening cancer diagnosis.

Now, the findings from the new study, published Nov. 4 in JAMA Psychiatry, suggest that psilocybin may be effective in the much wider population of patients who suffer from major depression than previously appreciated.

The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market, says Alan Davis, Ph.D., adjunct assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game changer if these findings hold up in future gold-standard placebo-controlled clinical trials. The published findings cover only a four-week follow-up in 24 participants, all of whom underwent two five-hour psilocybin sessions under the direction of the researchers.

Because there are several types of major depressive disorders that may result in variation in how people respond to treatment, I was surprised that most of our study participants found the psilocybin treatment to be effective, says Roland Griffiths, Ph.D., the Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Center for Psychedelic and Consciousness Research. He says the major depression treated in the new study may have been different than the reactive form of depression in patients they studied in the 2016 cancer trial. Griffiths says his team was encouraged by public health officials to explore psilocybins effects in the broader population of those with major depressive disorder because of the much larger potential public health impact.

For the new study, the researchers recruited 24 people with a long-term documented history of depression, most of whom experienced persisting symptoms for approximately two years before enrolling in the study. The average age of participants was 39; 16 were women; and 22 identified themselves as white, one person identified as Asian and one person identified as African American. Participants had to taper off any antidepressants prior to the study with the help of their personal physician to ensure safe exposure to this experimental treatment.

Thirteen participants received the psilocybin treatment immediately after recruitment and after preparation sessions, and 11 participants received the same preparation and treatment after an eight-week delay.

Treatment consisted of two psilocybin doses given by two clinical monitors who provided guidance and reassurance. The doses were given two weeks apart between August 2017 and April 2019 at the Johns Hopkins Bayview Medical Center Behavioral Biology Research Building. Each treatment session lasted approximately five hours, with the participant lying on a couch wearing eyeshades and headphones that played music, in the presence of the monitors.

All participants were given the GRID-Hamilton Depression Rating Scale a standard depression assessment tool upon enrollment, and at one and four weeks following completion of their treatment. On the scale, a score of 24 or more indicates severe depression, 1723 moderate depression, 816 mild depression and 7 or less no depression. At enrollment, participants had an average depression scale rating of 23, but one week and four weeks after treatment, they had an average depression scale score of 8. After treatment, most participants showed a substantial decrease in their symptoms, and almost half were in remission from depression at the follow-up. Participants in the delayed group didnt show decreases in their symptoms before receiving the psilocybin treatment.

For the entire group of 24 participants, 67% showed a more than 50% reduction in depression symptoms at the one-week follow-up and 71% at the four-week follow-up. Overall, four weeks post-treatment, 54% of participants were considered in remission meaning they no longer qualified as being depressed.

I believe this study to be a critically important proof of concept for the medical approval of psilocybin for treatment of depression, a condition I have personally struggled with for decades, says entrepreneur and philanthropist Tim Ferriss, who supported the funding campaign for this study. How do we explain the incredible magnitude and durability of effects? Treatment research with moderate to high doses of psychedelics may uncover entirely new paradigms for understanding and improving mood and mind. This is a taste of things to come from Johns Hopkins.

The researchers say they will follow the participants for a year after the study to see how long the antidepressant effects of the psilocybin treatment last, and will report their findings in a later publication.

Griffiths, whose research with psilocybin, begun in the early 2000s, was initially viewed by some with skepticism and concern, says he is gratified by Johns Hopkins support and heartened by the dozens of startups and research labs that have followed suit with their own research. He says numerous companies are now actively working to develop marketable forms of psilocybin and related psychedelic substances.

According to the National Institute of Mental Health, more than 17 million people in the U.S. and 300 million people worldwide have experienced major depression.

Other authors on the study include Frederick Barrett, Darrick May, Mary Cosimano, Nathan Sepeda, Matthew Johnson and Patrick Finan, all of Johns Hopkins.

The study was supported by philanthropic donors The Steven and Alexandra Cohen Foundation, Tim Ferriss, Matt Mullenweg, Craig Nerenberg,Blake Mycoskie and Dave Morin; as well as by grants from the Riverstyx Foundation and the National Institute on Drug Abuse (T32DA007209, R01DA003889, K23DA035915).

Conflicts of interest disclosed to JAMA Psychiatry include the following: Johnson serves as a consultant and/or advisory board member for AWAKN Life Sciences Inc., Beckley Psychedelics Ltd., Entheogen Biomedical Corp., Field Trip Psychedelics Inc., Mind Medicine, Inc., Otsuka Pharmaceutical Development & Commercialization, Inc. and Silo Pharma, Inc.

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Johns Hopkins Launches Center For Psychedelic Research

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The Center for Psychedelic and Consciousness Research will focus on how psychedelics affect behavior, brain function, learning and memory, the brains biology and mood. Studies of psilocybin in patients will determine its effectiveness as a new therapy for opioid addiction, Alzheimer's disease, post-traumatic stress disorder (PTSD), post-treatment Lyme disease syndrome (formerly known as chronic Lyme disease), anorexia nervosa and alcohol use in people with major depression. The researchers hope to create precision medicine treatments tailored to individual patients specific needs.

The centers establishment reflects a new era of research in therapeutics and the mind through studying this unique and remarkable class of pharmacological compounds, says Roland Griffiths, Ph.D., the centers director and professor of behavioral biology in the Department of Psychiatry and Behavioral Sciences and the Department of Neuroscience at the Johns Hopkins University School of Medicine.In addition to studies on new therapeutics, we plan to investigate creativity and well-being in healthy volunteers that we hope will open up new ways to support human thriving.

Johns Hopkins is deeply committed to exploring innovative treatments for our patients, says Paul B. Rothman, M.D., dean of the medical faculty at the Johns Hopkins University School of Medicine and CEO of Johns Hopkins Medicine. Our scientists have shown that psychedelics have real potential as medicine, and this new center will help us explore that potential.

The center will provide support for a team of six faculty neuroscientists, experimental psychologists and clinicians with expertise in psychedelic science, as well as five postdoctoral scientists.

I am thrilled about this magnificent opportunity that has been provided by enlightened private funders, says James Potash, M.D., M.P.H., the Henry Phipps Professor and director of the Department of Psychiatry and Behavioral Sciences. This center will allow our enormously talented faculty to focus extensively on psychedelic research, where their passions lie and where promising new horizons beckon.

The centers operational expenses for the first five years will be covered by private funding from the Steven & Alexandra Cohen Foundation and four philanthropists: Tim Ferriss (author and technology investor), Matt Mullenweg (co-founder of WordPress), Blake Mycoskie (founder of TOMS, a shoe and accessory brand) and Craig Nerenberg (investor).

We have to take braver and bolder steps if we want to help those suffering from chronic illness, addiction and mental health challenges, says Alex Cohen, president, Steven & Alexandra Cohen Foundation. By investing in the Johns Hopkins center, we are investing in the hope that researchers will keep proving the benefits of psychedelics and people will have new ways to heal.

The centers faculty will train graduate and medical students who want to pursue careers in psychedelic science, where there have historically been few avenues for career advancement.

This represents the largest investment to date in psychedelic research, as well as in training the next generation of psychedelic researchers, says Ferriss. I sincerely hope this ambitious Johns Hopkins center will inspire others to think big and establish more psychedelic research centers in the U.S. and overseas, as theres never been a better time to support such important work.

In 2000, the psychedelic research group at Johns Hopkins was the first to achieve regulatory approval in the U.S. to reinitiate research with psychedelics in healthy volunteers who had never used a psychedelic. Their 2006 publication on the safety and enduring positive effects of a single dose of psilocybin sparked a renewal of psychedelic research worldwide.

Since then, the researchers have published studies in more than 60 peer-reviewed journal articles. Their research has demonstrated therapeutic benefits for people who suffer from conditions including nicotine addiction, and depression/anxiety caused by life-threatening diseases such as cancer. It has paved the way for current studies on treatment of major depressive disorder. They have also led the field by publishing safety guidelines that have helped gain approval for psychedelic studies at other universities around the world, and by developing new ways to measure mystical and emotionally challenging experiences while under the influence of psychedelics. Their research also explores the interaction of psilocybin and meditation.

The groups findings on both the promise and the risks of psilocybin helped create a path forward for its potential medical approval and reclassification from a Schedule I drug, the most restrictive federal government category, to a more appropriate level. Psilocybin was classified as Schedule I during the Nixon administration, but research over the last decade has shown psilocybin to have low toxicity and abuse potential.

This very substantial level of funding should enable a quantum leap in psychedelic-focused research, adds Potash. It will accelerate the process of sorting out what works and what doesnt.

The Centers Staff Members:

Roland Griffiths, Ph.D., initiated the psilocybin research program at Johns Hopkins almost 20 years ago, leading the first studies investigating the effects of its use by healthy volunteers. His pioneering work led to the consideration of psilocybin as a therapy for serious health conditions. Griffiths recruited and trained the center faculty in psychedelic research as well.

Matthew Johnson, Ph.D., associate professor of psychiatry and behavioral science, has expertise in drug addictions and behavioral economic decision-making, and has conducted psychedelic research at Johns Hopkins since 2004 (with well over 100 publications). He led studies showing psilocybin can treat nicotine addiction. Johnson will lead two new clinical trials and will be associate director of the new center.

Frederick Barrett, Ph.D., assistant professor of psychiatry and behavioral sciences, has expertise in cognitive and affective (study of emotions) neuroscience, as well as psychological assessment. The focus of his past and ongoing research is the impact of psychedelics on emotional and brain functioning. Barrett will be the centers director of neurophysiological mechanism and biomarker assessment, overseeing a project that looks at how psychedelics change brain function and blood biomarkers that may predict response to psychedelics.

Albert Garcia-Romeu, Ph.D., is an instructor of psychiatry and behavioral sciences with expertise in assessing the psychological and subjective effects of psychedelics, and in addiction treatment with psychedelics. At the new center, Garcia-Romeu will lead several clinical trials and will supervise key elements of participant recruitment and care.

Natalie Gukasyan, M.D., is a Johns Hopkins trained psychiatrist and a study team member for the ongoing psilocybin depression study. Gukasyan will lead the study on psilocybin treatment for anorexia nervosa and serve as the new centers medical director.

Alan Davis, Ph.D., a part-time adjunct assistant professor of psychiatry and behavioral sciences, is one of the lead psilocybin session therapists on the ongoing psilocybin depression study and lead investigator of several past and ongoing survey studies exploring the effects of psychedelics in real-world and clinical settings. At the new center, he will provide clinical supervision and consultation across clinical trials.

Mary Cosimano, M.S.W., has been a member of the Johns Hopkins psychedelic research team since its inception and has served as a study guide for hundreds of psychedelic sessions. Cosimano will be the director of clinical services for the new center, with responsibility for training and supervising center staff members who prepare, support and provide after care for study participants.

William Richards, Ph.D., is a clinical psychologist who conducted research with psychedelics in the 1960s. He has been a member of the Johns Hopkins psychedelic research team since its inception.

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Psilocybin Treatment for Major Depression Effective for Up to a Year …

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A report on the new study was published on Feb. 15, 2022 in the Journal of Psychopharmacology.

Our findings add to evidence that, under carefully controlled conditions, this is a promising therapeutic approach that can lead to significant and durable improvements in depression, says Natalie Gukasyan, M.D., assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. She cautions, however, that the results we see are in a research setting and require quite a lot of preparation and structured support from trained clinicians and therapists, and people should not attempt to try it on their own.

Over the last 20 years, there has been a growing of research with classic psychedelics the pharmacological class of compounds that include psilocybin, an ingredient found in so-called magic mushrooms. According to the National Institute on Drug Abuse, psilocybin can produce perceptual changes, altering a persons awareness of their surroundings and of their thoughts and feelings. Treatment with psilocybin has shown promise in research settings for treating a range of mental health disorders and addictions.

For this study, the researchers recruited 27 participants with a long-term history of depression, most of whom had been experiencing depressive symptoms for approximately two years before recruitment. The average age of participants was 40, 19 were women, and 25 identified as white, one as African American and one as Asian. Eighty-eight percent of the participants had previously been treated with standard antidepressant medications, and 58% reported using antidepressants in their current depressive episodes.

After screening, participants were randomized into one of two groups in which they received the intervention either immediately, or after an eight-week waiting period. At the time of treatment, all participants were provided with six to eight hours of preparatory meetings with two treatment facilitators. Following preparation, participants received two doses of psilocybin, given approximately two weeks apart between August 2017 and April 2019 at the Behavioral Biology Research Center at Johns Hopkins Bayview Medical Center. Participants returned for follow-up one day and one week after each session, and then at one, three, six and 12 months following the second session; 24 participants completed both psilocybin sessions and all follow-up assessment visits.

The researchers reported that psilocybin treatment in both groups produced large decreases in depression, and that depression severity remained low one, three, six and 12 months after treatment. Depressive symptoms were measured before and after treatment using the GRID-Hamilton Depression Rating Scale, a standard depression assessment tool, in which a score of 24 or more indicates severe depression, 1723 moderate depression, 816 mild depression and 7 or less no depression. For most participants, scores for the overall treatment decreased from 22.8 at pretreatment to 8.7 at one week, 8.9 at four weeks, 9.3 at three months, 7 at six months and 7.7 at 12 months after treatment. Participants had stable rates of response to the treatment and remission of symptoms throughout the follow-up period, with 75% response and 58% remission at 12 months.Psilocybin not only produces significant and immediate effects, it also has a long duration, which suggests that it may be a uniquely useful new treatment for depression, says Roland Griffiths, Ph.D., the Oliver Lee McCabe III, Ph.D., Professor in the Neuropsychopharmacology of Consciousness at the Johns Hopkins University School of Medicine, and founding director of the Johns Hopkins Center for Psychedelic and Consciousness Research. Compared to standard antidepressants, which must be taken for long stretches of time, psilocybin has the potential to enduringly relieve the symptoms of depression with one or two treatments.

The researchers emphasize that further research is needed to explore the possibility that the efficacy of psilocybin treatment may be substantially longer than 12 months. Johns Hopkins is one of the sites of a national multisite randomized, placebo-controlled trial of psilocybin for major depressive disorder.

Other researchers who contributed to the study are Alan Davis, Frederick Barrett, Mary Cosimano, Nathan Sepeda and Matthew Johnson from the Johns Hopkins University School of Medicine.

The study was funded in part by a crowd-sourced campaign organized by Tim Ferriss and by grants from the Riverstyx Foundation and Dave Morin. Support for Alan Davis and Natalie Gukasyan was provided by a grant from the National Institutes of Health (T32DA07209, National Institute on Drug Abuse). Support for authors was also provided by the Center for Psychedelic and Consciousness Research, which is funded by the Steven and Alexandra Cohen Foundation, Tim Ferriss, Matt Mullenweg, Craig Nerenberg and Blake Mycoskie. The funders had no role in study design, data collection and analysis, or in decision to publish or manuscript preparation.

COI: Alan Davis is a board member of Source Research Foundation. Matthew Johnson has received grant support from the Heffter Research Institute that is unrelated to this study, and he is an advisor to the following companies: AJNA Labs, AWAKN Life Sciences, Beckley Psytech, Entheon Biomedical, Field Trip Psychedelics, Mind Medicine, Otsuka Pharmaceutical Development & Commercialization and Silo Pharma. Roland Griffiths is a board member of the Heffter Research Institute and has received grant support from the institute unrelated to this study. Griffiths is site principal investigator, and Johnson and Gukasyan are co-investigators for a multisite trial of psilocybin-assisted therapy for major depressive disorder sponsored by Usona Institute.

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Inside the Johns Hopkins Psilocybin Playlist – Hopkins Medicine

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Recently listening to Henryk Goreckis Symphony No. 3 brought Rob Jacobs back to a life-changing experience that happened a decade ago. After ingesting a psychedelic drug as part of a formal study at Johns Hopkins, he was lying on a couch at the research center, wearing eyeshades and feeling a deep emotional connection to the music playing through his headphones.

It was unbelievably beautiful. It literally moved me to tears, Jacobs, now 52, wrote in his post-session report in 2010. It seemed to capture the human condition, the beauty and sadness of existence. Melancholy but majestic. It was like I could see right into the heart of the matter with crystal clarity.

Jacobs remembers all these feelings, which came on as he began experiencing the effects of psilocybin the active ingredient in so-called magic mushrooms.

Goreckis 27-minute composition, also known as Symphony of Sorrowful Songs, is one of a collection of mostly classical pieces that help unlock elevated states of consciousness for study participants at the Johns Hopkins Center for Psychedelic and Consciousness Research. The seven-hour and 40-minute playlist, developed by researchers at Johns Hopkins, seeks to express the sweeping arc of the typical medium- or high-dose psilocybin session. (There is extra time built into the playlist, as session length can vary.)

This playlist supported the psychedelic experiences of those who participated in a new study published Nov. 4 in JAMA Psychiatry that found that psilocybin may show promise as a treatment for adults with major depression. A version of the playlist is available on Spotify.

The research center, which launched in September 2019, is believed to be the first such center in the country and the largest of its kind in the world. Its research focuses on how psychedelics can impact brain function and mood in healthy individuals and in patient populations, including conditions such as tobacco addiction and anorexia nervosa as well as anxiety and depression in people with life-threatening cancer.

The 2010 study Jacobs participated in examined the impact of psilocybin on spiritual practices in Jacobs case, meditation.

Psychologist Bill Richards, whose involvement in psychedelic research dates back to 1963, masterminded the playlist. As a researcher at the center, he emphasizes that the music is chosen for its ability to guide and support the participants experience.

Were exploring the human psyche, which might take you through some painful things in childhood. It may take you into some archetypal or visionary realms that you never knew were possible. It might take you beyond usual consciousness into a realm that feels eternal, says Richards.

Psilocybin researchers at NYU Langone Health and the Usona Institute in Madison, Wisconsin, have since adapted the playlist for their own research.

Richards reasoning for choosing classical music, as well as the structure of the Johns Hopkins playlist, inspired Usonas playlist, which uses seven pieces from the Hopkins list. Usona added Spanish guitar, non-Western classical music and modern works with some classical structure.

We were striving to create a blend of resonance with the music and emotional/psychological challenge that are thought to be beneficial, says Malynn Utzinger, co-founder and director of integrative medicine at Usona. We paid attention to the structure and tone of each section of the Hopkins list, and while we did not use quite as much strictly classical music, we wanted to create a list with a relatively high amount of structured music versus ambient.

The Birth of a Playlist

The playlist, which Johns Hopkins has used since it began its psychedelic research 20 years ago, dates back to 1967. At the time, Richards was involved in similar research at the Spring Grove Hospital Center in Catonsville, which is now part of the Maryland Psychiatric Research Center. There, he and other researchers investigated LSD, psilocybin and other psychedelics for treating substance use disorder, depression and the psychological distress associated with terminal cancer. The drugs were also studied for their effects on the professional lives of religious and mental health professionals.

We were working with 33 RPMs and turntables, and always trying to decide what record to play next, Richards recalls. We developed a certain intuitive list of favorites that just seemed to work well with a lot of people. Peoples experiences were going deeper and deeper, becoming very profound.

The late music therapist Helen Bonny, who also worked at the center, devised a number of cassette tape playlists with names such as peak experience for her doctoral thesis. When Richards joined center Director Roland Griffiths to initiate psilocybin research at Johns Hopkins in 1999, he created a formal playlist that drew partly from Bonnys tapes as well as from music he had used. His son Brian, who worked at the Johns Hopkins center as a postdoctoral research fellow, contributed in particular to what Richards calls the welcome back to Earth music.

The playlist is divided into segments: background music that plays as the participant arrives for his or her session; music that plays when the drug is starting to take effect, at which point he or she is lying down and wearing eyeshades and headphones; the ascent; the peak; the post-peak; and the welcome back music. There are usually two researchers in the room, referred to as guides, who simultaneously listen to the playlist through speakers.

The music in each section is deliberately chosen to accompany a particular part of the psychedelic journey. For example, Richards finds that Samuel Barbers iconic Adagio for Strings works well as participants approach the peak, when the effects of the psilocybin are steadily intensifying.

The music chromatically develops, and it goes up and reaches this exquisite climax and then comes back down, he says.

For the onset of the drug, on the other hand, he thinks the best music is unfolding and has a dependable structure.

Its going somewhere, its picking you up and carrying you. Its got some force, some substance, he says. It doesnt have very unpredictable changes of rhythm or something thats going to startle or frighten you. So, its a net of reassurance, almost, and of leadership.

The music helps keep participants from prematurely returning to normal conscious awareness, Richards says.

I think of it as a nonverbal support system, sort of like the net for a trapeze artist, he says. If all is going well, youre not even aware that the net is there you dont even hear the music but if you start getting anxious, or if you need it, its immediately there to provide structure.

The majority of the music is either instrumental or choral with non-English text, and purposefully so. In order to keep participants inside the experience, only the last section of the playlist uses selections with recognizable words.

Its the structure, the harmonic design, the richness, the unfolding, the harmonies, the dissonance, that really matters, he says. If youre truly trying to shift consciousness beyond the level of the everyday self, you have to get beyond language.

Jacobs, an adjunct instructor in English and literature at the Community College of Baltimore County and the Osher Lifelong Learning Institute at Johns Hopkins University, wasnt familiar with most of the music he heard during his sessions. Because of that, he felt that it didnt preload any experience and was more supportive than directive.

At the end of his session, however, he was glad to hear the familiar tune of the Beatles Here Comes the Sun, which Richards considers part of the welcome back to Earth music. (The song was included on previous versions of the current playlist, which can vary slightly between studies. For the JAMA study, the second to last song is Louis Armstrongs What a Wonderful World.)

A decade later, former study participant Jacobs says his experience with psilocybin showed him that life is a fundamentally spiritual experience. It made him less frightened of death, more centered and more committed to a spiritual path.

That kind of revelation is something Richards has seen from the beginning. In the early days of his research, he recalls most participants with substance use disorder being unfamiliar with Brahms symphonies. After the sessions, they bought the music for themselves.

It spoke [to them]. It took on meaning in the struggle, the unfolding, the dissonance being resolved. They could understand that that type of classical music is a language about life and human experience. And when youre in the music, its so different from listening to the music.

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Inside the Johns Hopkins Psilocybin Playlist - Hopkins Medicine

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