Patients in Australia will soon have legal access to the psychedelic drugs psilocybin and MDMA under a plan announced by regulators last month. But with no approved source of the drug available to therapists, patients will likely face bills in the tens of thousands of dollars to obtain the promising treatment.
Last month, the Therapeutic Goods Administration (TGA), the Australian government’s medicine and therapeutic regulatory agency, announced that qualified psychiatrists will be able to prescribe the psychedelic drugs psilocybin and MDMA for the treatment of certain mental health conditions beginning later this year. But the agency has not approved any products containing the promising psychedelic drugs, leaving mental health professionals to source the drugs themselves. Without a government subsidy to help cover the cost of the medications, psychiatrists estimate that patients will have to pay as much as AU$25,000 (nearly $17,000) and more out of pocket for psychedelic-assisted therapy.
“For the actual patient, it might be $25,000, $30,000 for a treatment,” said Dr. Stephen Bright, a senior lecturer at Edith Cowan University and director of the charity Psychedelic Research In Science & Medicine.
“I honestly don’t think, for the next 12 to 18 months post July 1, that these treatments will be very widely available at all,” he added. “The tight controls of therapy mean there are very few psychologists who put their hand up. There will be a few clinics that open up, but I don’t think we’re going to see the floodgates open.”
Dr. Paul Liknaitzky, the head of the Clinical Psychedelic Lab at Monash University, revealed last month that he and other mental health professionals will be partnering with investors to open a psychedelic-assisted therapy clinic in Melbourne. But training requirements for therapists and detailed guidelines for such therapy have yet to be issued by government regulators.
“There is a lack of detailed clarity from the TGA to help us understand how it’s going to roll out. We are concerned but cautiously optimistic,” he said.
Liknaitzky said that he and his colleagues will help establish protocols that set high standards for ethical and effective psychedelic-assisted therapy. But he warned that the high cost of treatment might make the treatment inaccessible to most Australians.
“Sensible and safe treatment approaches, based on decades of best-practice development, will include considerable screening, psychotherapy and other support. A typical course of treatment, spanning a few months, may be in the order of $25,000, plus or minus $10,000,” he said. “If it turns out to be cost-effective, it will be in the government’s interest to fund it.”
Psychedelic-Assisted Therapy Shows Promise
Ongoing research has shown that psilocybin, the primary psychoactive compound in magic mushrooms, has the potential to be an effective treatment for several serious mental health conditions, including PTSD, major depressive disorder, anxiety and substance misuse disorders. A study published in 2020 in the peer-reviewed journal JAMA Psychiatry found that psilocybin-assisted psychotherapy was a quick-acting and effective treatment for a group of 24 participants with major depressive disorder.
Separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. And in 2021, a study published in the journal NatureMedicine determined that MDMA, commonly known as ecstasy, is a highly efficacious and safe treatment for individuals with severe PTSD.
But Professor Chris Langmead of the Monash Institute of Pharmaceutical Sciences says that it is unlikely that public health agencies will cover the cost of such treatment until further research including a cost-benefit analysis has been completed.
“We’re trying to get a groundswell of research and funding so we can do the research, clinical studies and practice rollout [to ensure] that this is not purely a market-led solution where the most disadvantaged populations are missing out,” he said. “The TGA has put Australia at the forefront of the world and we really need to take the opportunity and make the most of it.”
University of Melbourne associate professor Gillinder Bedi said that a shortage of clinical staff trained in psychedelic-assisted therapy will also make the treatment difficult for patients to obtain.
“The infrastructure will get set up. There will be clinics. But the problem is we don’t have staff. People can’t even see psychiatrists under normal conditions,” she said. “If you put two clinical psychologists in a room for eight hours, at a [Medicare] billing rate of $120 an hour – which is not what people charge, they charge $200 to $300 – you have an enormously expensive treatment. I think it could get higher [than $25,000].
“No matter which way you look at it, it will take time away from other treatments and cost a whole bunch of money. It’s unclear who will foot the bill, some organizations are trying to set up philanthropic funding,” Bedi added. “But it’s going to be for people with money, in the initial stages at least.”
Advocates for the medical use of psilocybin mushrooms in Canada launched a petition to call upon the federal government to take action. Interest in psilocybin-assisted therapy continues to grow to combat end-of-life anxiety, depression, addition, and PTSD, among many other conditions.
Petition e-4334 was launched on March 16—an online “Petition to the Government of Canada,” which, according to law, will have to be presented in the House of Commons if it meets certain conditions, Microdosereports. Petitions must be certified by the Clerk of Petitions, for instance, in order to be presented to the House. They also must be signed by at least 500 residents of Canada, and a Member of Parliament must authorize them.
Advocates want to green-light therapeutic psilocybin in any form, and listed several specific conditions that can be improved.
“We, the undersigned, compassionate Canadians, call upon the Government of Canada to allow Canadians to have timely unrestricted access to therapeutic psilocybin in any form as needed to alleviate their suffering via Section 56 exemptions,” the petition reads.
The petition provides three reasons why psilocybin-assisted therapy should be legalized, including the mushroom’s low potential for harm:
Strong medical evidence exists that access to psychedelic-assisted therapy can effectively treat existential suffering in dying, depression, anxiety, addiction, PTSD, and other mental health conditions, improving quality of life;
Psilocybin required for psilocybin-assisted therapy is currently only available in clinical trials and by special individual permission from Health Canada despite its low potential for harm; and
It is paradoxical and unethical to allow physicians to provide MAID for their patients while preventing the same physicians from treating their end of life distress with psilocybin.
In order to sign the petition, signers must be a Canadian citizen or a resident of Canada.
Psilocybin-Assisted Therapy in Canada
Meanwhile, one particular case is drawing attention to the issue of psilocybin-assisted therapy.
Thomas waited for over 500 days for approval, but his exemption to continue to use psilocybin for medical purposes was denied by Minister Carolyn Bennett. Health Canada denied Hartle’s permission to continue psilocybin-assisted therapy, which attracted a lot of attention and criticism from the psychedelic community. Hartle believes Health Canada and the Ministers of Health are just waiting for him to die.
Psilocybin-assisted psychotherapy is the only thing that has helped him deal with his end-of-life anxiety and he says that he needs safe, legal access to it.
It’s stories like Hartle’s that are fueling the effort to legalize psilocybin-assisted therapy in Canada.
Apex Labs will launch a trial that will explore the efficacy of APEX-52 (psilocybin) for veterans suffering from depression and post-traumatic stress disorder. Apex Labs received a “no objection letter” from Health Canada on Oct. 24, 2022.
Welcome to TheCannadelics Sunday Edition, our weekly newsletter, sent to you every Sunday morning at 11am est with the main articles of the week. This week we look into DIY mushroom grow kits, and DIY mushroom spores, as well as other drugs your can grow on your own.
If you happen to like mushrooms, we have a great newsletter for you!
But first thing first, Prof. Raphael Mechoulam, the ‘godfather’ of cannabis research passed away this weekend. We would like to honor and celebrate his life and groundbreaking work on Cannabis and cannabis research. Rest in peace dear payoneer.
In our deals section, you could find rare opportunities on Amanita gummies, Power 9 gummies and Magic Mushroom spores.
As always, the best deals on cannabis and psychedelic products are saved to our subscribers, as well as free premium content, so subscribebelow:
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Welcome to the Cannadelics Sunday edition, going out every Sunday with the top stories from the cannabis and psychedelics industries. This week we have an interesting selection of stories, as well as an exciting deal on magic mushroom spores. Scroll down to learn more.
Before moving forward, let us take a moment to honor and celebrate the life and groundbreaking work of Professor Raphael Mechoulam, who recently passed away on Friday. Widely regarded as the “godfather” of cannabis research, Professor Mechoulam made significant contributions to the field and helped pave the way for a better understanding of the potential benefits of cannabis.
We extend our heartfelt condolences to his loved ones and colleagues. May he rest in peace and be forever remembered as a beloved pioneer in the field of cannabis research.
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This week we are focusing on growing mushrooms at home! Not only DIY mushroom grow kits is a great way to save money and stress by having the product available to you at moment’s notice, but it’s a really fun hobby for someone who isn’t looking for anything too complicated or labor-intensive. Learn more below!
While gardening often requires a lot of time, labor, space, and supplies, the opposite is true for shrooms. With a few easy-to-find items, good quality mushroom spores, and some clean substrate, you can set up the whole thing in a dresser drawer then literally just sit back and watch the magic happen. If you want to stock up on spore syringes, you’re in the right place!
One of the great things about psilocybin is, much like cannabis, the mushrooms it comes from, can be grown in home. So, here are some basic instructions to highlight the general process. Prospective growers should do further research, and remember, these instructions are for growing all mushrooms.
Growing mushrooms does not have to be some intimidating and complicated endeavor. It should be fun and relatively hands off. In my opinion, the best cultivation products combine the elements of affordability, convenience, and ease of use. If a product is well-priced, user-friendly, and makes your life easier in some way, what could really be better? With that in mind, I made the following list of what I think are some of the best magic mushroom grow kits on the consumer market.
Everyone knows that you can grow weed at home, regardless of how much of a hassle it may be. But did you know you can also grow many other “drugs” at home? Psilocybin, mescaline, DMT, salvia, ibogaine, and many other hallucinogens are plant-based, and some can easily be grown in a personal garden space.
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Professor Raphael Mechoulam, an award-winning Israeli chemist, instructor of Medicinal Chemistry at the Hebrew University of Jerusalem, and esteemed medical cannabis researcher, has passed away on Thursday, March 9th, 2023, at 92 years of age. Professor Mechoulam was a respected intellectual, a visionary, and a true leader in his field. His contributions to science and medicine will continue to have a lasting impact on the cannabis industry and society as a whole. RIP dear Mechoulam, you will forever be in our hearts.
First and foremost, it’s not good to smoke anything while pregnant – point, blank, period. However, it can be safer than alternative medications when you’re at a loss for treatment options, so many women choose to self-medicate. Recently pregnant women have been checked for the compound THCM, to see if they’ve smoked weed while pregnant. What exactly is THCM? And what are the implications of the test?
We all know that pharmaceutical pain medications are much stronger than most natural alternatives. Think cannabis vs oxycontin, it’s no comparison. So why are a growing number of people turning away from opioids in favor of milder treatment options? Aside from obvious safety issues with the former, the answer to this question lies in part in how we, as a society, view pain in the first place.
To kick off the summer, Zach Leary, son of renowned psychedelic researcher Timothy Leary, is hosting a tight knit event called the Basement Tapes, during which he will share with attendees numerous different never-before-seen videos, documents, and articles that will give the public a much better understanding of psychedelic therapy. Leary is working in partnership with the Psychedelic Institute, a non-profit organization dedicated to spreading knowledge and improving access to “medically-safe and evidence-based” psychedelic therapies.
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We hope you enjoyed this week’s review. We work hard to find and verify the best products, so we may include affiliate links to support the maintenance and development of this site. We hope you enjoyed our Do It Yourself articles.
Best, The Cannadelics team
*** Disclaimer: As the legality of cannabinoids and psychedelics changes between state to state, you should always check with your local authorities first.
“Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses. It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies,” said Mace in a press release. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”
If passed, the bill would amend the CSA’s definition of “currently accepted medical use with severe restrictions” to “include the active ingredients of therapies that receive an FDA Breakthrough Therapy Designation or Expanded Access approval.” In effect, this would allow the Drug Enforcement Administration to move certain “breakthrough therapies” of Schedule I substances into the Schedule II category, which is less restrictive when it comes to research and studies regarding medical compassionate use.
“According to recent studies, certain Schedule I substances such as MDMA and psilocybin could offer major advancements in the treatment of depression, severe post-traumatic stress disorder, and addiction,” said Booker. “This bill will eliminate unreasonably burdensome rules and regulations that delay or prevent researchers from studying these breakthrough mental health treatments, and will provide access to these promising therapies for eligible patients who urgently need care.”
The newer version of the bill includes a section stating that substances that move from Schedule I to Schedule II could be moved back to Schedule I “if the drug no longer has a currently accepted medical use with severe restrictions and the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule I pursuant to subsections,” the text states. In that case, the Attorney General would act within 90 days of receiving a letter from the Secretary to issue an interim final rule.
Originally, Booker and Paul filed the previous version of this bill in November 2022, but it did not receive any progress in the Senate. Previously, Booker and Paul also introduced “Right to Try” legislation in July 2022. “As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” said Paul last year. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”
The growing support of psychedelics as medicine also lends evidence that patients could benefit from it. A press release from Mace explains that more than 40 organizations have come out in support of the new bill, such as Veteran Mental Health Leadership Coalition, Reason for Hope, and Special Operations Association of America. It’s also important to mention that the Australian government recently announced on Feb 3 that it would be rescheduling MDMA and psilocybin to allow physicians to prescribe those substances to patients suffering from post-traumatic stress disorder (PTSD) or treatment-resistant depression.
Many patients could benefit from access to MDMA and psilocybin treatments, especially veterans. There are other efforts currently underway to help boost research efforts for cannabis as a way to treat PTSD and chronic pain in military veterans. Senate Bill 326, or the VA Medicinal Cannabis Research Act, would require that the U.S. Department of Veteran Affairs (VA) conduct research and report findings to congress regarding its therapeutic value.
Therapists who administer psychedelic treatments to patients apparently like to use psychedelics themselves.
That is the chief takeaway of a new study published in the journal Psychedelic Medicine, revealing that “Personal experience with psychedelics was notably common in this sample of psychedelic therapists.”
The findings, the authors of the study noted, are “the first to delineate the personal use of psychedelics among professionals and can inform a pressing debate for the field.”
That psychedelic therapists use psychedelics might seem like a “dog bites man” caliber headline, but as the authors noted, an “emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves.”
“Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects of their training,” they wrote.
For the study, the researchers said that they “broadly review[ed] the literature on experiential learning in psychotherapy and psychiatry as well as the history of personal use of psychedelics by professionals,” and then reported “on the results of a survey that was sent to all 145 therapists associated with Usona Institute’s Phase II clinical trial of psilocybin for major depressive disorder.”
They said that 32 of those individuals participated in the survey, representing a 22% response rate.
In their conclusion, the authors said that “study was limited by a low response rate and a lack of diversity among participants,” as “the majority of psychedelic therapists identified as white, female, and having doctoral degrees.”
The authors also noted that six individuals “did not fully complete the survey and were removed from all analyses,” and that “all six of these participants stopped the survey when prompted to answer questions regarding their personal substance use.”
“Future research is needed to address these limitations as well as to identify whether personal experience with psychedelics contributes to therapists’ competency or introduces bias to the field,” they wrote.
“One interpretation of the low response rate is that only a small proportion of the practitioners working as psychedelic facilitators felt comfortable answering questions—anonymously and confidentially—about their personal experiences with psychedelic substances, but other explanations such as the lack of compensation for participating in the study may also be relevant,” the authors added.
Still, the findings are significant, particularly as psychedelic therapy continues to become more prevalent.
“This sample of psychedelic therapists had considerable experience using classic psychedelic drugs and related hallucinogens themselves, with 28 of 32 (88%) endorsing use of a classic psychedelic and all but 1 participant trying at least one hallucinogen-related substance. This figure differs from the general population lifetime rate of psychedelic use, which tends to be around 10–15%; although several recent studies have indicated that usage seems to be increasing. Only one of four individuals without previous classic psychedelic experience had previous psychedelic training, making these individuals unique and relatively psychedelic-naive candidates to provide the treatment. Given their paucity of experience in the field, these individuals may represent interesting case studies in understanding the role of experiential learning with psychedelics,” the authors wrote.
They continued: “In terms of intentions, personal development and spiritual growth were the most common reasons reported for substance use, particularly with the classic psychedelics. However, most participants also reported intentions related to having fun and curiosity … Although the role of intentions has often been noted as being critical to the acute experience and subsequent outcomes among psychedelic users … there has been limited research prospectively testing the relationship between intentions and drug effects. Nonetheless, our results add to a growing body of literature suggesting a distinct set of intentions among psychedelic users.”
With a medical cannabis program that stinks of reefer madness and the decision to create COVID internment camps, Australia is the last country you’d expect to legalize medical psychedelics. But a recent decision by the Australian Therapeutic Goods Administration (TGA) will soon make it legal for psychiatrists to prescribe psilocybin and MDMA come July 2023. This would be like if Health Canada came to their senses and made Canada’s psychedelic medicine exemption as accessible as the government-assisted suicide program. (Telling […]
Following in the footsteps of Colorado and Oregon, Utah is the latest state to consider the benefits in therapy that psilocybin mushrooms can provide.
Senate Minority Leader Luz Escamilla, (D-Salt Lake City) unveiled Senate Bill 200 on Feb. 9, a bill that would legalize psilocybin mushrooms for medical use in Utah.
Deseret Newsreports that SB 200 would set up a program that mirrors the program behind Utah’s medical cannabis market. Utah’s compromise bill, the Utah Medical Cannabis Act, which was passed in 2018 allows patients with a healthcare provider’s verification, to purchase medical cannabis.
The bill would allow Utahns ages 21 and older to receive a psilocybin-assisted treatment directly from a psilocybin therapy provider. Qualifying conditions would include depression or anxiety if the patient has tried at least one other treatment route, PTSD, and people who are receiving hospice care.
Utah’s Republican-controlled Legislature will likely whittle down some of the bill’s provisions. Escamilla, for instance, said she’s prepared to propose changes to narrow the bill to a pilot program capped at only 5,000 participants. Escamilla compared the proposal to medical cannabis in the state.
“Cannabis has given us a really good opportunity to understand that we can use other natural things … to help us. Now, we have to be careful, and I think we have really good safeguards,” Escamilla said.
“This is not a free-for-all,” she said. “This is not for everyone, but if it’s for someone that is desperate (for help) with their anxiety, depression and PTSD—that’s pushing many, unfortunately, to suicide, I want them to have access in a way that’s safe, that we can regulate.”
“Seeing all the promising research, I really wanted to understand it better for myself,” Alaina Chatterley, a clinical social worker toldDeseret News. “And I’ve had some traumas in my own life that I wanted to better understand.”
“It’s almost like finding the antidote, in my mind, to depression, to anxiety, because the antidote is (discovering) that you are ultimately powerful and ultimately lovable and loved and worthy,” she said. “And if you can find that antidote to depression and anxiety … you’ve gotten to the root cause, and everything else gets easier.”
Libertas Institute, a Utah-based libertarian think-tank, and the Utah Patients Coalition are backing the bill. “Many Utahns currently use psilocybin illegally and are seeing profound improvement in their mental health,” said Desiree Hennessy, executive director of the Utah Patients Coalition. “This medicine should be legalized so these patients don’t jeopardize their legal rights in pursuit of health.”
In 2022, the Utah Legislature passed House Bill 167, which called for the creation of a mental illness psychotherapy drug task force to review psilocybin mushroom research. The report issued by the task force found that psilocybin is safe and effective.
While the task force found psilocybin to be effective, the executive summary of the task force’s report reads that the “most rigorous and cost-effect approach to ensuring that the people of Utah have safe access to the most effective programs in psychedelic-assisted psychotherapy would be to wait for the fast-track FDA rulings for psilocybin.”
Last month, non-profit Utah Mushroom Therapy launched a petition to encourage Utah legislators to pass a bipartisan bill that allows the legal use of psilocybin for clinical and academic purposes.
Escamilla hopes the proposal could be considered in a Utah Senate committee within about a week.
Sen. Ron Kouchi introduced Senate Bill 1454 on Jan. 25, which was unanimously passed in the Hawaii Senate Committee on Health and Human Services (HHS) on Feb. 6. If the bill becomes law, it would establish a “therapeutic psilocybin working group” (managed by the Office of Wellness & Resilience [OWR]) to “Examine the medicinal and therapeutic effects of psilocybin or psilocybin-based products vis-à-vis mental health including post-traumatic stress disorder, depression, anxiety, and end-of-life psychological distress.”
The group would also be tasked with evaluating how markets such as regulators in Oregon and Colorado are tackling their own state psilocybin programs, with the goal of developing a comprehensive approach for Hawaii. In effect, the place would ensure that psilocybin access is safe, accessible, and affordable for patients.
During the hearing on Feb. 6, numerous testimonies were presented in favor of passing the bill to allow psilocybin access. The HHS compiled these testimonies on a 117-page document, which included a variety of speakers, beginning with a statement from Tia Roberts Hartsock, Executive Director of the OWR with the Office of the Governor. “As negative impacts of the COVID-19 pandemic continue to show up in our daily lives, promising interventions for mental health disorders should be included in conversations relating to trauma,” Hartsock wrote. “To make informed decisions on how we should address and resource attention on complex social issues like mental health disorders, research needs to be examined. The OWR supports the purpose of SB1454 to establish a working group to provide recommendations on their findings on the potential benefits of the therapeutic use of psilocybin.”
The Drug Policy Forum of Hawaii Board President, Nikos Leverenz, also expressed support for the bill. “Hawai῾i should endeavor to work more proactively in creating a climate that is conducive to allowing qualified medical professionals to use psilocybin as a therapeutic tool for those who could benefit from its supervised use,” Leverenz said.
Patients who had personal experiences with plant medicine treatments also shared how the bill could help countless others. “l can attest without hesitation that plant medicines are both safe and effective means by which to address and recover from intense psychological and physical trauma,” said Wyly Gray, Executive Director of Veterans of War. “Veterans of War sees firsthand the healing potential of these ancient medicines day in and day out, and we advocate strongly for their decriminalization on behalf of a nation of veterans suffering from the after-effects of war, as a group, we deserve a safe and effective path towards recovery; as a group, we simply want to come home. This is bigger than the failed War on Drugs; lives are lost every day.”
This year has been productive for Hawaii legislators looking into plant medicine and legalization. On Jan. 11, Rep. Jeanné Kapela spoke about introducing an adult-use cannabis bill. “We all know, and Hawaii’s people know, that it is high time to legalize recreational cannabis use for adults in Hawaii. This year we stand on the precipice of history,” Kapela stated. “Following the recommendations of a task force devoted to addressing cannabis policy, we now have a roadmap for legalizing recreational cannabis in our islands.” Kapela has not yet introduced her bill, but she explained that it would include a mass expungement program. “Social equity. People. That is what forms the heart of our proposal,” she explained.
The people of Hawaii also recently showed support for cannabis legalization through a poll conducted by the Hawaii Cannabis Industry Association. The survey revealed that 52% of Hawaii residents are in favor of legalization (with 31% saying they are opposed).
Regulators in Australia this week announced that qualified psychiatrists will be able to prescribe “medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) … for the treatment of certain mental health conditions” later this year.
Under newly permitted uses, those substances “will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard,” but they will “remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials” for all other uses.
The Therapeutic Goods Administration, the Australian regulatory arm overseeing medicine and therapy in the country, said on Friday that the reclassification of the substances will take effect on July 1.
“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients,” the announcement said.
The administration said that it will “permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression,” which it regards as “the only conditions where there is currently sufficient evidence for potential benefits in certain patients.”
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients,” the administration said in the announcement on Friday.
“The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling,” the regulatory agency continued. “There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.”
The administration said that the changes in classification for the substances “were made by a senior medical officer at the TGA who has been delegated by the Secretary of the Department of Health and Aged Care to exercise their authority to make decisions about the scheduling of medicines in the Poisons Standard.”
“The decision maker recognised there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions,” the administration explained. “However, as with all medicines, there are risks with psilocybin and MDMA. Although these substances are themselves relatively safe when administered in the doses used in conjunction with psychotherapy and in a medically controlled environment, patients are in an altered state of consciousness when undergoing psychedelic-assisted psychotherapy. It was decided that by limiting prescribing to authorised psychiatrists and for TRD or PTSD the benefits for patients and public health will be greater than the risks.”
As we venture further into this new era of psychedelic innovation and discovery, more folks are becoming aware of the potential benefits of substances like psilocybin, LSD, or ketamine. But what about dimethyltryptamine, or DMT, an active chemical in the hallucinogenic plant brew ayahuasca?
U.K.-based biotech company Small Pharma is conducting the first major study of DMT and its potential for treating major depressive disorder (MDD). The company, which focuses on short-duration psychedelic-assisted therapies for mental health conditions, completed its Phase IIa clinical trial, finding a “significant and clinically relevant reduction in depression symptoms” two weeks after dosing, compared to the placebo group, according to a news release.
“SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57% at three months following a single dose of SPL026,” said Dr. Carol Routledge, Small Pharma’s chief medical and scientific officer.
Because of DMT’s short hallucinogenic duration, it’s possible the substance could be an even better clinical alternative to other psychedelics requiring longer treatment sessions.
The trial, and one of the largest for a short-acting psychedelic, involved 34 patients with moderate to severe MDD, and those who were already medicated were withdrawn from treatment prior to dosing. Participants were given a short IV fusion of 21.5 mg of intravenous DMT, resulting in a 20 to 30-minute psychedelic experience.
The two-phased study also included a blinded, randomized, placebo-controlled phase, where the primary endpoint assessed the DMT group versus the control group at two weeks post-dose. All participants were enrolled into an open-label phase of the study, which enabled the assessment of the “durability of the antidepressant effect,” along with comparative efficacy and safety of a one-dose versus a two-dose regimen of DMT.
Researchers said, following analysis of key secondary endpoints, that there was a rapid onset of antidepressant effects one week post-dose, though no apparent antidepressant effect was observed between a one- and two-dose regimen of intravenous DMT.
The intravenous dose of DMT was also well tolerated by all patients who received an active dose, with no drug-related serious adverse events, including suicidal ideation or behavior, reported.
“The results are exciting for the field of psychiatry,” said Dr. David Erritzoe, a clinical psychiatrist at Imperial College London and chief investigator of the Phase I/IIa study. “For patients who experience little benefit from existing antidepressants, the potential for rapid and durable relief from a single treatment, as shown in this trial, is very promising.”
Small Pharma CEO George Tziras also spoke to the potential impact of the trial’s results, particularly for those hundreds of millions of people who live with MDD worldwide. Citing the greater confrontation of psychedelic medicine, addressing the decades of failure on behalf of pharmaceutical drugs, Tziras said the “scale of unmet needs” merits the further investigation of other more effective remedies.
“Our goal is to develop proprietary, scalable and reimbursable short-duration psychedelics with supportive therapy to address this need,” Tziras said. “I am delighted with our top-line results, which demonstrate proof-of-concept for SPL026 and provide encouraging support for our broader portfolio. I want to thank each patient who took part in this trial, as well as their families, the trial investigators, the employees of the trial sites and everyone who has supported the successful completion of this study.”
Research surrounding DMT, and ayahuasca, is still limited—as is psychedelic research surrounding mental health in the grand scheme—though it’s slowly beginning to amp up, as similar studies boast promising results for psychedelic treatment of otherwise treatment-resistant mental health conditions.
One recent study found that ayahuasca use, although a different experience than that of Small Pharma’s study participants, resulted in a high rate of adverse physical effects and challenging psychological effects, though they were generally not severe. In fact, the study found that many participants continued to attend ceremonies and generally perceived that the benefits overshadowed any adverse effects—88% of people surveyed considered adverse effects as an expected part of the process of growth or integration.
Next up, the detailed results of the Phase IIa trial are expected to be presented at upcoming scientific meetings and published in a peer-reviewed journal.