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TGA announces final decision: MDMA and psilocybin will not be rescheduled

<p>In October, Cosmos <a style="font-size: 14px;" rel="noopener" href="https://cosmosmagazine.com/health/body-and-mind/tga-psilocybin-report/" target="_blank">reported</a><span style="font-size: 14px;"> on the pending decision from Australia’s drug regulator on the potential rescheduling of psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard.</span></p> <div class="copy"> <p>The shift would see these treatments move beyond their current use solely in restricted clinical trials to broader applications in the treatment of a range of psychiatric disorders.</p> <p>At the time the article was written, the Therapeutic Goods Administration (TGA) had received 453 supportive submissions for MDMA and 575 for psilocybin, and 11 opposed for each. A growing body of experts was pushing strongly to have the two treatments down-scheduled.</p> <p>Earlier this week, the TGA announced its <a rel="noopener" href="https://www.tga.gov.au/scheduling-decision-final/notice-final-decisions-amend-or-not-amend-current-poisons-standard-relation-psilocybin-and-mdma" target="_blank">final decision</a>: MDMA and psilocybin will not be rescheduled for use as medicines at this time.</p> <p>This will be a blow to those who have been advocating for the substances’ inclusion as controlled medicines, citing evidence of safety and efficacy for a range of clinical treatments. However, a number of researchers have welcomed the news.</p> <p>Citing research published by Dr Martin Williams, Executive Director of Psychedelic Research In Science &amp; Medicine (PRISM Ltd), and colleagues, the TGA announcement notes that any changes to the scheduling of MDMA and psilocybin must be done with the current Australian clinical context in mind, ensuring that Australia’s medical community is adequately equipped with expertise in both administration and ethical use.</p> <p>Williams has subsequently expressed his support for the announcement, noting that this decision reflects insufficient evidence rather than any identified safety concerns.</p> <div class="newsletter-box"> <div id="wpcf7-f6-p177271-o1" class="wpcf7"> <p style="display: none !important;"> </p> <!-- Chimpmail extension by Renzo Johnson --></div> </div> <p>“While excellent late-phase clinical research is ongoing around the world, and the results so far have been very promising, we agree that the standards of evidence required for formal approval and implementation still need to be met,” Williams says.</p> <p>He reiterates that the decision doesn’t mark the end of the road for the drugs in a clinical setting, but simply ensures research continues to work towards establishing safe practices.</p> <p>“Australian research needs to be conducted to ensure successful implementation in the local environment, to engage our medical community, and to pave the way towards appropriate training and accreditation of Australian mental health professionals in this game-changing area of mental health practice,” he says.</p> <p>Fellow PRISM director Dr Stephen Bright agreed with this position, stating that rescheduling at this time would be “premature given there is still no accredited training in Australia”.</p> <p>“My concern was that the application for rescheduling, as submitted, did not go far enough to ensure adequate clinical governance for the use of these powerful therapeutic drugs,” says Bright.</p> <p>“Without an established and integrated system of clinical governance for the provision of psychedelics, rescheduling alone may open the door to unsafe and unethical practices. Appropriate training in this novel and paradigm-changing approach is still broadly lacking, even among mental health professionals.”</p> <p>“At PRISM Ltd, our focus remains on completing the research we are engaged in that will put Australia in a better position to make these drugs medicines.”</p> <!-- Start of tracking content syndication. Please do not remove this section as it allows us to keep track of republished articles --> <img id="cosmos-post-tracker" style="opacity: 0; height: 1px!important; width: 1px!important; border: 0!important; position: absolute!important; z-index: -1!important;" src="https://syndication.cosmosmagazine.com/?id=177271&amp;title=TGA+announces+final+decision%3A+MDMA+and+psilocybin+will+not+be+rescheduled" alt="" width="1" height="1" /> <!-- End of tracking content syndication --></div> <div id="contributors"> <p><em><a rel="noopener" href="https://cosmosmagazine.com/australia/psychedelics-will-not-be-rescheduled/" target="_blank">This article</a> was originally published on <a rel="noopener" href="https://cosmosmagazine.com" target="_blank">Cosmos Magazine</a> and was written by <a rel="noopener" href="https://cosmosmagazine.com/contributor/jamie-priest" target="_blank">Jamie Priest</a>. Jamie Priest is a science journalist at Cosmos. She has a Bachelor of Science in Marine Biology from the University of Adelaide.</em></p> <p><em>Image: Getty Images</em></p> </div>

Mind

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Jacinda Ardern replicated in unusual object

<p dir="ltr">Jacinda Ardern has had an unusual item named after her, after ecstasy pills pressed with her name were discovered being sold on New Zealand’s underground drugs market.</p> <p dir="ltr">The pink pills of Class-B methylenedioxymethamphetamine (MDMA) include a crude caricature of her face, with the<span> </span><a rel="noopener" href="https://www.nzherald.co.nz/nz/ecstasy-pills-featuring-prime-minister-jacinda-arderns-name-for-sale/AAFICMYRMVQJTZJFD2337ADQWE/" target="_blank"><em>NZ Herald</em></a><span> </span>reporting that they are being sold for $NZD 30-40 each ($AUD 28-37) online</p> <p dir="ltr">When the publication asked the Prime Minister’s office for comment, they were directed to the police.</p> <p dir="ltr"><img style="width: 0px; height: 0px;" src="https://oversixtydev.blob.core.windows.net/media/7846489/jacinda1.jpg" alt="" data-udi="umb://media/ec7fa88fc2e84160b2b0f2218cd3cf8c" /></p> <p dir="ltr"><em>The illicit ‘Jacinda Ardern’ pills have surfaced online. Image: NZ Herald</em></p> <p dir="ltr">A police spokesperson said the sale of the pills is “not something we’re aware of”.</p> <p dir="ltr">MDMA is a “party drug” that is especially popular with clubbers and summer festival goers.</p> <p dir="ltr">Community drug testing service Know Your Stuff online list of flagged pills doesn’t list the “Jacinda Ardern” pills, but the group warns that doesn’t mean taking it is risk-free.</p> <p dir="ltr">“If your pill does not appear on this page, this is not a guarantee that it is safe.”</p> <p dir="ltr">The discovery comes after New Zealand recently became the first country in the world to permanently legalise drug checks at large scale events, including music festivals.</p> <p dir="ltr">Know Your Stuff was appointed to run the<span> </span><a rel="noopener" href="https://www.ladbible.com/news/latest-ecstasy-pills-made-to-look-like-jacinda-ardern-found-in-new-zealand-20211220" target="_blank">pilot program</a>, offering drug-checking services at events and helping people know what pills they intend to consume actually contain.</p> <p dir="ltr">This year, the service has reported increasing incidents of people taking what they believe to be pure MDMA which was either just cathinones or contained just enough MDMA to “spoof” the tests.</p> <p dir="ltr">Synthetic cathinones, also known as “bath salts”, have a similar euphoric effect as MDMA but wear off faster and can lead to anxiety, paranoia, gastric distress, seizures or respiratory failure.</p> <p dir="ltr">Mephedrone, a cathinone commonly found in the country, has been linked to a number of deaths in the UK and Europe.</p> <p dir="ltr"><em>Image: Getty Images</em></p>

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New psychedelic treatment for PTSD discovered

<p><span style="font-weight: 400;"> A new study has found that the key ingredient in the illicit drug known as Ecstasy or Molly could ease the symptoms of post-traumatic stress disorder.</span></p> <p><span style="font-weight: 400;">When combined with intense talk therapy, the study reports that MDMA significantly eased symptoms in those struggling with severe PTSD.</span></p> <p><span style="font-weight: 400;">“This is a big deal,” Steven Gold, a clinical psychologist in Fort Lauderdale and professor emeritus at Nova Southeastern University in Florida told </span><a href="https://www.sciencenews.org/article/mdma-ecstasy-ptsd-symptoms-psychedelic-psychology?utm_source=email&amp;utm_medium=email&amp;utm_campaign=latest-newsletter-v2&amp;utm_source=Latest_Headlines&amp;utm_medium=email&amp;utm_campaign=Latest_Headlines"><span style="font-weight: 400;">ScienceNews</span></a><span style="font-weight: 400;">. “All other things being equal, the use of psychedelic medication can significantly improve the outcome.”</span></p> <p><span style="font-weight: 400;">Though </span><a href="https://www.nature.com/articles/s41591-021-01336-3#citeas"><span style="font-weight: 400;">the findings</span></a><span style="font-weight: 400;">, published in </span><span style="font-weight: 400;">Nature Medicine</span><span style="font-weight: 400;">, are preliminary, they offer hope to the millions of people with PTSD who are in desperate need of new treatments. Antidepressants such as Zoloft and Paxil are often prescribed to these patients, but don’t work for an estimated 40 to 60 percent of people with PTSD.</span></p> <p><strong>How did they test it?</strong></p> <p><span style="font-weight: 400;">The study involved 90 people across 15 sites in the United States, Canada, and Israel. All participants received 15 therapy sessions with therapists who were trained to guide people experiencing the drug.</span></p> <p><span style="font-weight: 400;">Of the 90 participants, half received MDMA in three eight-hour therapy sessions while the other half received placebos.</span></p> <p><span style="font-weight: 400;">MDMA, true to its nickname Ecstasy, evokes feelings of bliss and social connectedness. Those who took either the drug or the placebo wore eye covers, listened to music, and occasionally talked to their therapist about their experience during the sessions.</span></p> <p><span style="font-weight: 400;">By the end of the 18-week trial, most participants showed fewer PTSD symptoms such as unwanted, intrusive memories.</span></p> <p><span style="font-weight: 400;">But, those who took MDMA experienced the best benefits.</span></p> <p><span style="font-weight: 400;">By the trial’s end, 67 percent of the participants taking MDMA had improved so much they no longer qualified for a PTSD diagnosis.</span></p> <p><span style="font-weight: 400;">In comparison, 32 percent of those taking the placebo no longer met the criteria for a PTSD diagnosis by the end of the study.</span></p> <p><span style="font-weight: 400;">Many participants had been living with severe PTSD for years.</span></p> <p><span style="font-weight: 400;">“Typically, we see PTSD as a disorder for life. Now, we may begin to let that go,” said Eric Vermetten, a psychiatrist at the Leiden University Medical Centre in the Netherlands who works with veterans and military members with PTSD and was not involved in the study.</span></p> <p><span style="font-weight: 400;">Though it isn’t exactly clear how the drug changes the brain, some imaging studies suggest MDMA dampens activity in the amygdala, a structure in the brain involved in fear. Other results from studies in mice suggest the drug may heighten social learning, which may strengthen the relationship between a patient and their therapist.</span></p> <p><span style="font-weight: 400;">The study did require a significant amount of emotional work before, during and after the MDMA sessions too.</span></p> <p><span style="font-weight: 400;">“[MDMA] is not a magic pill,” co-author Amy Emerson said.</span></p> <p><span style="font-weight: 400;">Since more than 75 percent of the cohort were white, Gold said it is unclear whether the effects would be similar with a more diverse group of people. Nor is it clear how long the effects might last.</span></p> <p><span style="font-weight: 400;">Another clinical trial is in the works, but restrictions on MDMA in the United States have complicated future research.</span></p> <p><span style="font-weight: 400;">“There are a lot of barriers to break down related to this treatment,” Emerson said. “And there is a lot of hope.”</span></p>

Mind