An Illinois state senator recently introduced a bill to legalize the supervised therapeutic use of psilocybin, the primary psychedelic compound in magic mushrooms. The legislation, known as the Compassionate Use and Research of Entheogens (CURE) Act, was introduced by Democratic Senator Rachel Ventura earlier this month.

If passed, the legislation (Senate Bill 3695) would legalize the supervised therapeutic use of psilocybin for adults. The bill is an attempt to provide new alternative options for treatment-resistant conditions such as anxiety, depression, PTSD, substance abuse, eating disorders and other serious mental health conditions.

“As mental health concerns rise throughout our state and nation, it’s imperative to acknowledge that conventional treatments don’t always suffice,” Ventura said in a statement on February 14. “Psilocybin shows promise as a potential solution, particularly for those grappling with PTSD and other mental health disorders. The ongoing research and trials have yielded encouraging results.”

Although the legislation legalizes supervised psychedelic therapy, it does not allow for the sale, use, or personal possession of the drug. The bill would also establish the Illinois Psilocybin Advisory Board under the Department of Financial and Professional Regulation. The new state agency would create a training program, ethical standards and licensing requirements for psilocybin therapy practitioners.

“At the current pace, demand for therapeutic psychedelic experiences and retreats is far outpacing the supply of psychedelic guides, therapists and practitioners. We are asking that lawmakers in Illinois not let unnecessary barriers stand in the way of safe, compassionate access and quality assurance for psychedelic healing,” said Jean Lacy, founder of the Illinois Psychedelic Society. “Illinois has the opportunity to be a standard-setter for other states, creating training centers, developing standards of care, and providing a model for other states to follow. Illinois’ mental health crisis is growing and there are serious consequences to withholding these medicines from those who need it.”

FDA Designates Psilocybin As A Breakthrough Therapy

The U.S. Food and Drug Administration designated psilocybin treatment as a breakthrough therapy in 2018, indicating that the therapy has the potential to be a substantial improvement over existing options. Last year, the agency published its first draft guidance on clinical trials for psychedelics in a further indication of the progress being made exploring the potential of psilocybin and other psychedelic compounds to have a profound impact on the treatment of mental illness.

In 2021, Oregon became the first state to legalize the therapeutic use of psilocybin, followed by the passage of a similar measure by Colorado voters in 2022. Legislators in more conservative states are also taking action to reform psychedelics laws, including the approval of a psilocybin medical research bill by an Indiana Senate committee earlier this year.

Democratic Representative LaShawn Ford introduced similar legislation (House Bill 1) in the Illinois House of Representatives last year. Ford and Ventura are now working together “to develop robust legislation” to legalize psilocybin therapy in Illinois. The Senate bill is co-sponsored by fellow Democrats Senator Willie Preston and Senator Mike Porfirio. In the House, Representatives Jonathan Carroll, Harry Benton, and Kelly Cassidy, also all Democrats, have signed on as co-sponsors of the legislation.

The Law Enforcement Action Partnership (LEAP), a nonprofit organization made up of current and former law enforcement professionals advocating for the reform of drug prohibition laws, issued a statement in support of the CURE Act last week.

“Law Enforcement Action Partnership recognizes this bill as nothing short of life-saving. Providing a proven means for people to work through their traumas and live happier, healthier, and more productive lives,” said Dave Franco, a retired Chicago police officer. “The benefits for mental and behavioral health can also have sizable impacts on community health and public safety.”

Senate Bill 3695 was filed by Ventura on February 9. The measure has not yet been assigned to a legislative committee for consideration.

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The U.S. Drug Enforcement Administration (DEA) has made its position on psilocybin and psilocin, two psychedelic compounds produced by “magic” mushrooms, fairly clear as states across the U.S. have begun softening regulations on their therapeutic use. 

Though it may seem contradictory under the current medicinal usage and continued scientific findings showing the potential benefits of psilocybin use under the supervision of a therapist, under the Controlled Substances Act (CSA), the compounds — like cannabis — are classified as Schedule I substances, deeming “no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.”

Though at the start of 2024, the DEA’s Drug and Chemical Evaluation Section Chief Terrence Boos confirmed that mushroom spores, or the reproductive organ of mushrooms — similar to seeds, containing the genetic information needed for new mushrooms to grow and reproduce — are in fact not considered controlled substances under the CSA.

The kicker? The spores must not contain psilocybin, psilocin or any other controlled substances under the CSA. So long as individuals do not actually let spores to germinate, allowing them to eventually grow into fungi containing controlled compounds, the DEA stated they are not classified as controlled substances, according to a response dated Jan. 2, 2024 clarifying the status.

Breakthrough Leaving a Number of Unanswered Questions

“If the mushroom spores (or any other material) do not contain psilocybin or psilocin (or any other controlled substance or listed chemical), the material is considered not controlled under the CSA,” the response reads, as first reported by Kight on Cannabis. “However, if at any time the material contains a controlled substance such as psilocybin or psilocin (for example, upon germination), the material would be considered a controlled substance under the CSA.“

While this may seem like a given, in that spores on their own do not contain forbidden compounds, the DEA confirmation still acts as a pivotal moment pertaining to the broader conversations surrounding natural psychedelics, like magic mushrooms.

As psilocybin and psilocin have increased in mainstream popularity, many have questioned the legality of selling and using spore kits, with some even being convicted for possessing and selling these materials for public use, as noted by Kight in his report.

It’s possible that sale of these kits may ramp up as the DEA confirmed its position, though the DEA also did not explicitly state that the sale of spore kits is lawful. Making matters even more complicated, some states explicitly prohibit the sale and use of spores on their own.

Kight noted that the distinction ultimately lies in whether these kits are considered “drug paraphernalia,” which largely depends on how consumers use spore kits and how sellers market them. Drug paraphernalia includes “equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing… [or] producing” a controlled substance. 

Therefore, marketing a spore kit as a means to grow magic mushrooms, or even the act of purchasing a kit with the intent to grow mushrooms containing psilocybin or psilocin, could cause the seller or the user to be open to prosecution.

Kight calls the DEA response a “positive clarification of a long-debated issue,” while cautioning readers around the widespread use and sale of spore kits: “At a minimum, buyers and sellers should understand the legal issues with a lawyer, and act accordingly,” Kight writes.

The DEA recently clarified a similar issue pertaining to cannabis, in that cannabis is still a federally prohibited substance while the seeds used to produce the cannabis plant are not, so long as they do not exceed 0.3% THC by dry weight. Seeds falling under that threshold are classified as federally legal hemp, per the 2018 Hemp Bill, as confirmed by Boos in a January 2022 letter.

Rescheduling and DEA’s Continued Interest in Psychedelic Mushrooms

While cannabis is currently in the midst of potentially being reclassified from Schedule I to Schedule III of the CSA, it appears that psilocybin and related compounds aren’t set to follow suit any time soon. 

In December 2023, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected a motion for a rehearing of an earlier court decision in which lawyers for a Washington State doctor inquired about rescheduling psilocybin under the CSA. 

Lawyers had asked the panel to revisit the ruling, specifically to address their argument that federal statute requires a referral to the FDA to conduct a “scientific and medical evaluation and scheduling recommendation.” The court ultimately ordered a remand back to the DEA, effectively denying the rehearing request.

Still, it appears that the DEA is continuing to research the potential benefits behind psilocybin, along with a handful of other banned substances. 

A DEA notice posted earlier this month noted a request for 20,000 grams of psilocybin in its 2024 aggregate production quotas, which was previously established in October at 8,000 grams and increased later to 15,000 grams. The DEA also requested 24,000 grams of psilocin, unchanged from its November 2023 amount.

“There has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” the DEA wrote. “DEA has received and subsequently approved new registration applications for Schedule I researchers and new applications for registration from manufacturers to grow, synthesize, extract, and prepare dosage forms containing specific Schedule I hallucinogenic substances for research and clinical trial purposes.”

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The American Medical Association, aka the AMA, has recently implemented new standards to assign specific codes to psychedelic therapies. This move coincides with the Food and Drug Administration’s (otherwise known as the infamous FDA) ongoing review of an application to legalize MDMA as a prescription drug in the treatment of post-traumatic stress disorder (PTSD). These codes, known as Current Procedural Terminology (CPT) III, were established in July as a result of a collaboration between the AMA, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS), and COMPASS Pathways. 

On September 13, 2023, MAPS released the findings from their latest Phase 3 Trial, which investigates the effectiveness of MDMA-assisted therapy in treating PTSD. After intense expert peer review, these results were published in the esteemed journal Nature Medicine. The research involved 104 participants with PTSD. They were randomly assigned to receive either MDMA or a placebo pill across three sessions, each spaced a month apart, over a three-month period. Upon completion of the study, results found that 72% of the participants in the MDMA group no longer met the criteria for PTSD, in contrast to only 48% in the placebo group.

Effective starting on Monday, New Year’s Day of 2024, these codes aim to standardize psychedelic treatments and provide coverage and reimbursement for these therapies — contingent upon FDA approval, of course. 

Currently, it’s pretty impossible to get insurance to cover any psychedelic meds. This development would be a near miracle moment, an integration that previously seemed impossible to cover for many seekers or simply those trying to heal themselves. This added a financial barrier to entry for many people with PTSD, such as vets, who may have a more challenging time finding work to pay for the treatment, cruelly ironically, getting in their way of work and contributing to the economy in a way necessary to enjoy the treatment. 

The FDA is now evaluating a drug application submitted by MAPS. The FDA has a deadline of mid-February to determine whether to accept or reject this application. If granted, this would require the FDA to complete its evaluation within six months, as opposed to the typical 10-month review period.

“Having recently filed a new drug application for MDMA-assisted therapy for PTSD, these new CPT codes are an important step forward to pave the way for its future use should it be approved by the FDA,” Amy Emerson, CEO of MAPS PBC, said in a press release on Tuesday. “It is critical that there is a path to cover not only the MDMA but also the medication sessions should this novel investigational approach be approved.”

And now for some seemingly boring but crucial information: The CPT III codes are provisional classifications created to track the utilization of emerging technology. Their purpose is to make the reimbursement processes easier and support the accessibility of psychedelic therapies. If they’re deemed effective, these codes can become permanent CPT I codes, which would help facilitate the aforementioned coverage and reimbursement. Among the codes approved by the AMA, one is specifically designated for compensating healthcare professionals who oversee and intervene in psychedelic-assisted therapy. The other two are intended to reimburse ancillary health professionals and clinical staff involved in treatments.

If approved, MDMA would be the first FDA-approved psychedelic to treat a mental health condition. This comes after three decades of research into the medicine. Currently, ketamine, which is used off-label, is technically a dissociative anesthetic with hallucinogenic effects, but often embraced by the psychedelic community, it is the only federally legal similar medicine used to treat PTSD and treatment-resistant depression. 

Numerous studies have shown that psilocybin, the trippy ingredient in magic mushrooms, also has the potential to aid patients suffering from treatment-resistant depression, especially when combined with therapy.

In Oregon, the first state to legalize psilocybin (remember, it’s still illegal on a federal level), the demand for psilocybin services is so high that there are over 3,000 individuals on the waiting list to visit a legal psilocybin service center, which folks flocking from all over the world to seek treatment in a safe and monitored setting. Research also recently found that psilocybin could be a promising treatment for depression in bipolar patients. 

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A company focused on developing novel treatments for mental health this week announced that it has submitted an application to the U.S. Food and Drug Administration seeking the approval of MDMA-assisted therapy. The application, which was submitted by MAPS Public Benefit Corporation (MAPS PBC) after more than three decades of clinical research into the potential use of MDMA-assisted therapy for PTSD, represents a significant achievement in the effort to develop safe and effective mental health therapies utilizing psychedelic drugs.

In 2017, the FDA granted Breakthrough Therapy designation for psychotherapy utilizing MDMA, the psychedelic drug commonly known as Ecstasy, indicating that the therapy is a significant improvement over existing treatments. But so far, MDMA-assisted therapy has not been approved by any regulatory agency as an approved option for mental health treatment. 

MAPS PBC is a subsidiary of the groundbreaking psychedelics nonprofit advocacy group the Multidisciplinary Association for Psychedelic Studies (MAPS), which has been working to develop new psychedelic-based treatments for decades. After reporting promising results from two clinical trials investigating MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD), MAPS PBC announced in January that the company planned to submit the new drug application (NDA) to the FDA in the third quarter of 2023.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, CEO of MAPS PBC, said in a statement on Tuesday. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

Application Based on Decades of Research

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies known as MAPP1 and MAPP2, which evaluated the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in the peer-reviewed journal Nature Medicine.

Earlier this year, MAPS PBC reported results from MAPP2, which enrolled 121 participants with PTSD for a 12-week treatment period. The participants recruited for the study reflected the demographics of those living with the disorder in the United States, with people of color representing more than half of those enrolled in the study. 

Of the 121 participants, 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. At the end of the study, the research showed significant improvement in PTSD among participants in the MDMA group as measured by commonly used clinical diagnostic scales.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” Emerson said in a statement at the time.

FDA To Review Application

Because of MDMA’s designation as a breakthrough therapy, MAPS PBC has requested that the FDA grant a priority review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration would be required to reschedule MDMA, making it available for prescription medical use.

Sherry Rais, the co-founder and CEO of Enthea, a licensed, third-party administrator of health insurance benefits working to provide coverage for psychedelic-based therapies as an employee benefit, said that the FDA’s pending review of MDMA-assisted therapy “represents a significant milestone, not just for the healthcare and psychedelic industries, but also for humanity as a whole.”

“Millions of people living with PTSD are hoping to access MDMA-assisted therapy as a safe, effective healing modality,” Rais wrote in an email. “This moment serves as a promising leap toward formally acknowledging this treatment and providing universal access.”

Shawn Hauser, a partner at Vicente LLP and the co-chair of the law firm’s Hemp and Cannabinoids Department, also serves as a leading member of the firm’s Psychedelics and Emerging Therapies practice. She said that the potential FDA approval of MDMA is “hopeful and promising given its incredible therapeutic potential, especially for a country devastated by an opiate crisis.”

“The submission of the first psychedelic-assisted therapy to the FDA for approval, along with the FDA’s recommendation to reclassify cannabis to Schedule III, acknowledging its medical use, highlights a very promising shift in federal drug policy,” Hauser said in a statement to High Times.

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For the first time, a psilocybin mushroom license was granted in New Zealand, marking a major milestone in a Māori health science. The effort was led by Rangiwaho marae, based south of Gisborne in New Zealand. 

According to an Oct. 26 joint media release, Rua Bioscience, a biopharmaceutical business also based in Tairāwhiti, was granted the license. The company is involved as a research and development support partner, exploring psilocybin’s potential in treating conditions like addiction.

The license is the result of a collaboration of a network of rongoā Māori practitioners, ESR (Institute of Environmental Science and Research), University of Auckland, University of Waikato, Manaaki Whenua Landcare Research, Mātai Medical Research Institute, an iwi health provider and other community stakeholders. 

They plan to uncover the therapeutic potential of psilocybin, which has been used in traditional medicine in Aotearoa (the Māori-language name for New Zealand) and around the world for thousands of years.

Rangiwaho marae in Tairāwhiti, Gisborne is exploring psilocybin’s potential in treating methamphetamine addiction, particularly in rewiring the brain in ways traditional ways cannot. It’s based in Te Ao Māori and unlike other clinical studies that only use a single extract or synthetically produced psilocybin, this study plans to use the whole mushroom. One of the researchers is Dr. Mitchell Head (Tainui; Ngāti Mahuta, Ngāti Naho), a neuroscientist based at Waikato University. 

“We are hugely excited about this opportunity for our whānau” said Rangiwaho trustee Jody Toroa. “These taonga are provided by the atua and our people have been using them for healing and wellness for centuries. We have been learning from tohunga about how the taonga can help shift ingrained habits and unhelpful ways of thinking, to open up new possibilities.”

“It is a privilege to be involved in this ground-breaking project and we are excited to be able to support this kaupapa,” said Paul Naske, CEO of Rua Bioscience. “It is exciting to see Australia and other jurisdictions embracing innovative and potentially life-changing medical research with psilocybin and exciting for Rua Bioscience to now be part of such a great national collaboration.

Collaborating with Rangiwaho, ESR, rongoā practitioners and university medical researchers provides us with a unique opportunity to explore cultivation techniques that can contribute to research undertaken in a culturally safe environment with the support of a range of expertise. Bringing together Mātauranga Māori, psychedelic traditions and contemporary neuroscience research is world-leading innovation based here in Tairāwhiti.”

Project regulatory advisor Manu Caddie said the decision by Manatū Hauora, the Ministry of Health, to grant the cultivation license reflects sea change in the attitudes towards psychedelic substances in the field of therapy. It will help position New Zealand taking the initiative on this evolving new branch of research.

Official Information provided by Medsafe last month to the New Zealand Drug Foundation showed that no one in New Zealand has been prescribed psilocybin to date in a clinical setting. 

Psychedelic-Assisted Therapy Trials Boom in New Zealand

While Australia became the first country to legalize psilocybin (and MDMA) last June for therapeutic purposes, New Zealand has no plans to reclassify psilocybin. However, psychedelic-assisted therapy trials with exemptions are booming in New Zealand.

Three applications have been made for using psilocybin in clinical trials, all in the past 18 months.

The New Zealand Herald reported last year that a new trial is set to look into whether psilocybin could prove to be effective treatment for people with severe depression. University of Otago Christchurch professor Marie Crowe said the trial will take 10 weeks and involve eight weeks of psychotherapy and two full doses of psilocybin.

“Depression is such a pervasive thing in New Zealand, and elsewhere, and people don’t always respond to anti-depressants and some people don’t want to take them,” Crowe said at the time. “So this would provide another option.”

Researchers associated with the University of Otago, the University of Auckland and independent provider Mana Health are also currently investigating whether MDMA can help cancer patients.

Progress is being made with cannabis as well. New Zealand health regulators last year began allowing the use of domestically produced medicinal cannabis products, ending patients’ reliance on imported medical cannabis products. The Ministry of Health allowed access to local medicines beginning on Sept. 9, opening a new opportunity for New Zealand cannabis growers and manufacturers.

Under New Zealand’s medicinal cannabis legalization laws, any licensed general physician can prescribe cannabis medications to any patient to treat any health condition. But since 2017, only imported cannabis medicines have been approved for use by patients. 

A cannabis legalization initiative to legalize pot in 2020 failed, after being rejected by voters. Totals from the election held on October 17, 2020 showed that 53% of voters chose not to support the initiative, while 46% voted in favor of cannabis legalization. 

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Much like the United States, Europe is currently figuring out how to incorporate psychedelic therapy into its healthcare landscape most effectively. A lobby group representing developers and professionals within the industry advocates for including seasoned practitioners as integral members of a “multidisciplinary advisory body.” They would serve as a guiding authority, offering essential insights to regulators and healthcare practitioners regarding optimal practices as the field expands and changes. This effort comes from the European Psychedelic Access Research and European Alliance (PAREA), as reported by Politico, as per a briefing document slated for submission to the European Medicines Agency (EMA).

It basically says that those with actual experience with psychedelics should have influence. In both legal cannabis and psychedelics space, there is often a feeling that those with an actual relationship with the substance, rather than simply a desire to profit from it, makes for better business. 

Europe still needs to legalize any psychedelic treatments. However, as Australia and parts of the United States are already offering psychedelic therapy, many lawmakers in Europe want to be prepared to hit the ground running. Having such an advisory board (with people who have experience with these substances) will make psychedelic treatment easier to implement. 

In July, Australia became the first country in the world to authorize psilocybin and MDMA use through a doctor’s prescription to treat mental health conditions like post-traumatic stress disorder (PTSD) and depression. Both were legalized for therapeutic use. 

In 2019, Denver, Colorado, became the first U.S. city to decriminalize psilocybin. Cities such as Oakland, Santa Cruz, and Washington D.C. have followed suit. In 2020, Oregon both decriminalized it and legalized supervised therapeutic use, with Colorado passing a similar law in 2022. 

Psilocybin remains illegal under federal law.

Ketamine, which is technically a (legal) dissociative anesthetic with hallucinogenic properties, is FDA-approved for treatment-resistant depression in the U.S. under as “esketamine,” the S enantiomer of ketamine, as that’s how Johnson & Johnson could patent and sell it under the brand name Spravato. Often, doctors prescribe an off-label actual ketamine nasal spray that one can have made in a compound pharmacy. 

A study by the American Medical Association, published late last month, found growing evidence that psilocybin, the mind-altering ingredient in magic mushrooms, is a potentially effective treatment for those suffering from depression. Psilocybin is also being tested to treat people with anorexia. 

MDMA is currently being studied with successful results for its capacity to treat PTSD, among other mental health conditions.

Such substances would be under review of the proposed multidisciplinary advisory body. Before an upcoming EMA workshop on psychedelic treatments, PAREA urged the regulator to provide centralized leadership for the practical and clinical aspects of these therapies, including their delivery methods.

Unlike conventional pills, such as SSRI antidepressants, psychedelics require a comprehensive regimen of pre- and post-care, as well as support during the experience itself. PAREA wants to ensure that this care is uniformly standardized, drawing upon consensus from a diverse group of stakeholders. 

In psychedelic spaces, this pre- and post-care is known as integration, or the belief that one needs more than the drug itself. Integration typically involves therapy before the trip and afterwards, helping one take what they learned and “integrate” it into everyday life. One may also need more than one session or return for boosters, as with ketamine IV therapy and other psychedelic therapies. Even within recreational psychedelic spaces, many people use a “trip sitter,” or at least one trusted person to abstain and look after them. 

An EU advisory body “would benefit from the collective knowledge of various stakeholders, including the EMA, [the European Monitoring Centre for Drugs and Drug Addiction], national competent authorities, professional organizations, health care professionals and managers, psychedelic organizations, patients’ organizations, drug developers, and the wider community,” the briefing states.

PAREA told POLITICO these professional organizations could include the Open Foundation and the Beckley Academy in the Netherlands and the Mind Foundation in Germany. These groups train therapists in psychedelics using the latest research from institutions like Imperial College London and Johns Hopkins University. Some programs include experiential learning (getting high) on substances like psilocybin or ketamine. The Beckley group teaches people to “navigate non-ordinary states to better serve your clients,” and also runs psilocybin retreats. 

“The importance of ensuring that the therapeutic model adopted is evidence-based and in the best interest of the patients cannot be overstated,” the lobby group’s briefing states.

PAREA also advocates for the EMA to ensure consistent delivery strategies throughout Europe. “Centralized coordination would offer an efficient mechanism to propel the field forward, rather than individual EU countries initiating their own work groups,” it states.

Meanwhile, setting the stage for future generations, psychedelic knowledge and industry are now being taken seriously in academia. Last month, the University of California, Berkeley’s Center for the Science of Psychedelics launched a free online course titled “Psychedelics and the Mind.” The new class is another expansion (and win) for the Center, launched three years ago. The course will be available for free. 

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The Land Down Under made a historic move over the weekend, though some experts are cautious as to how exactly the major change will fully pan out.

Australia became the first country in the world to authorize psilocybin and MDMA use through a doctor’s prescription to treat psychiatric conditions like post-traumatic stress disorder (PTSD) and depression. Beginning Saturday, July 1, both drugs were authorized for therapeutic use after regulators approved the up-and-coming treatment option earlier this year.

Australia Makes Psychedelic History

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), approved the move back in February and indicated that the change wasn’t made lightly. Rather, it came after a nearly three-year decision-making process, including extensive consultation with a number of experts on the topic. MDMA, also known as ecstasy or molly, was approved as a treatment for PTSD, while psilocybin, the psychoactive substance in psychedelic mushrooms, was approved for treatment-resistant depression.

Both drugs will be down-scheduled from Australia’s strictest category, schedule 9 donating “prohibited substances,” to schedule 8, or controlled drugs, but solely for medical use in psychedelic-assisted psychotherapy.

While cities and states in the United States have gradually eased restrictions on psychedelics to similarly usher in a new era of therapeutic care, Australia is the first country in the world to down-schedule psilocybin and MDMA for clinical treatments. The country will now allow these substances to be adopted as part of therapy sessions under the guidance of a qualified and authorized practitioner. 

Mounting Evidence on the Potential of Psychedelic Treatments

While psychedelic drugs like psilocybin and MDMA have been long criminalized, research has opened the doors to a potentially game-changing alternative for mental health treatment, especially for conditions that cannot be treated with traditional methods.

Among myriad other studies on the topic, one 2022 study involving the largest randomized, controlled, double-blind study of psilocybin to date showed “significant” improvements to treatment-resistant depression among participants. The study involved two doses, 1 mg and 25 mg of psilocybin, and found that those who received a 25 mg dose with psychological support experienced a “highly statistically significant reduction in symptoms of depression after three weeks.”

Similarly, researchers have heavily examined MDMA as a potential treatment for PTSD as the ongoing psychedelic renaissance unfolds. The results of one clinical trial from earlier this year “support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” according to Amy Emerson, chief executive officer of MAPS Public Benefit Corporation which conducted the study.

These studies are just two of many in the growing psychedelic medicine field, though more research is still needed to fully unravel the potential of drugs like MDMA and psilocybin. And some Australian experts have expressed concern about the recent move.

Concerns and Hopes for the Future of Mental Health

For one, these are psychedelic drugs, so using them carries the risk of having a bad trip. Susan Rossell is a psychiatrist at Swinburne University of Technology in Melbourne and is working on Australia’s only active clinical trial to test psilocybin-assisted psychotherapy for treatment-resistant depression. Rossell indicated that one of the gaps research has yet to close is determining what type of patient is best suited to the treatment.

“It’s not for everybody. We need to work out who these people are that are going to have bad experiences, and not recommend it,” Rossell told Nature, adding that she fears, should the drug be improperly administered, treatment could result in bad trips and leave patients with more psychological issues than they came in with.

In a broader sense, it’s clear that the shift around psychedelic medicine is moving much more quickly than cannabis did prior, as a similarly criminalized drug that is now undergoing major reform. Beyond Australia, some leaders and experts have similarly questioned whether things are moving too quickly.

Others have indicated Australia’s move sets a major milestone for psychedelic-assisted therapies. Payton Nyquest, co-founder and CEO of psychedelic-focused mental healthcare company Numinus, praised regulators for making the bold move.

“The TGA’s approval surrounding MDMA and psilocybin for specific and controlled usage is a welcome step forward for Australia as well as the entire mental health field,” Nyquvest wrote in an email to Forbes. “This decision impacts the millions of people who are enduring treatment-resistant mental health conditions and opens a pathway to profoundly change their lives. I look forward to watching progress being made on a global scale as a result of our industry’s collective mission to help the world heal.”

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Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/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. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

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A Utah lawmaker has introduced a bill to explore the potential of psychedelic drugs to treat serious mental health conditions including depression, anxiety and PTSD. The legislation, House Bill 167, was introduced on Tuesday by Utah state Representative Brady Brammer, who noted that the measure “doesn’t legalize anything.”

“It asks our Huntsman Mental Health Institute and other experts in the field to review the science that’s out there, the research that’s out there, and make any recommendations that they have if they feel psychedelics can be safely administered through a prescription basis and under what circumstances,” Brammer said in a television news interview.

If passed, HB 167 would direct the state’s Health and Human Services Department to create a Mental Illness Psychotherapy Drug Task Force. The group would “study and make recommendations on drugs that may assist in treating mental illness,” according to the text of the legislation. The legislation specifies the makeup of the task force, which would include mental health professionals, researchers and patients.

Although the bill does not specifically mention psychedelics or any particular drug, the task force would be authorized to “provide evidence-based recommendations on any psychotherapy drug that the task force determines may enhance psychotherapy when treating a mental illness.” The legislation would empower the task force to study the research into psychedelic drugs, which has shown the potential to treat serious mental health conditions.

“We need effective tools to treat mental illness,” Brammer said in a statement to local media. “If psychedelics can be helpful and safely administered, we need them in our toolbox.”

Cannabis Activists Support Utah Psychedelics Bill

Brammer’s bill is supported by groups that campaigned for Proposition 2, the 2018 ballot initiative that legalized medical marijuana in Utah. Kylee Shumway, the medical director for the Utah Patients Coalition, said that psychedelics may be able to help residents of the state who are struggling with mental illness.

“We have higher rates of depression and anxiety than a lot of other states and even for people that are looking for help, there’s not enough psychiatrists; there’s not enough mental health professionals to help them,” said Shumway. “And a lot of the medications aren’t working.”

Research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. Research published in the journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

“It’s very promising,” Shumway exclaimed. “There are some huge studies that have just been finished recently on psilocybin that put it head to head against SSRIs which are antidepressants and psilocybin performed better across the board.”

“Utah has some of the finest researchers in the areas of psychiatry and neurosciences at Huntsman Mental Health Institute,” said Brammer. “This bill seeks to leverage that expertise, along with other experts grappling with mental illness, to review the research results, and if appropriate, make recommendations on how to safely administer these therapeutics under the care of qualified physicians.”

Steve Urquhart, a former Republican Utah state senator, also supports Brammer’s bill to explore the therapeutic potential of psychedelic drugs.

“Psychedelics changed my life,” he told local media. “It changed the way I see myself, the way I regard myself, and that allows me to see others and love others a lot more.”

Urquhart is the founder of The Divine Assembly, a Utah church that promotes religious and responsible use of psilocybin. 

“I’ve always been a bit of an activist at heart, and I decided I wanted to form a church where people can have these freedoms to worship with psychedelics,” Urquhart said. “I tell people, don’t get too lost on psychedelics; The Divine Assembly is about connection, and psychedelics can help with that.”

Urquhart believes that state lawmakers are likely to appreciate the cautious approach HB 167 takes to explore the benefits of psychedelics and may eventually support the legislation.

“Remember, this is Utah. Of course, we’re likely to take a slower approach to something like this,” he noted. “But on things like this, when the process runs, when it works, Utah can kind of come up with some magic. I’m optimistic about this.”

Brammer introduced HB 167 in the Utah House of Representatives on January 18. The bill has been referred to the House Rules Committee for consideration.

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