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Study to explore how psilocybin alters brain function

The mechanistic study of psilocybin is the first to measure how the compound alters the brain’s use of contextual cues during visual tasks.



Study to explore how psilocybin alters brain function launched

The clinical trial is aiming to understand how psilocybin alters brain function in order to improve treatment options for mental illness. 

Led by the University of Minnesota Medical School (UoM), the study is also aiming to identify how long brain changes last in a bid to aid therapists in identifying a therapeutic window of opportunity for psychotherapy interventions.

Investigating the visual effects of psilocybin will illuminate general principles by which psilocybin might act on other circuits in the brain, including cognition, emotion and therapeutic outcomes, potentially yielding new scientific insights on the relationship between psilocybin and mental health.

The study is enrolling 46 carefully vetted participants with good physical health and experience taking psilocybin, but who do not have a current or previously-diagnosed major mental illness or substance use disorder.

Lead investigator, Jessica Nielson, PhD, assistant professor in the Department of Psychiatry and Behavioral Sciences and core faculty at the University’s Institute for Health Informatics, commented: “One arm of the study, which is being led by predoctoral researcher Link Swanson, looks at visual perception and how it is affected by psilocybin. Another arm of the study is looking at the time-course of brain changes produced by psilocybin, using diffusion tensor imaging (DTI), a type of MRI scan that can visualise dendritic spines, which until now, has only been shown in animal models.

“The point is to enrol people who are comfortable with psilocybin and are able to navigate their own mind very well because they will be asked to do visual performance tasks while in an altered state of consciousness.”

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Study participants will undergo a series of baseline tests to measure blood and brain biomarkers of neuroplasticity prior to taking psilocybin – including blood draws and MRI and EEG scans. They will then undergo one dosing session with psilocybin and one with a placebo (niacin).

Nielson continued: “It’s a triple-blind study, so neither the participants, researchers nor the statistician will know which compound participants get first, and we will monitor them the entirety of their session. During their session, they will be asked to wear an EEG and perform visual perception tasks on a computer.

“After that day, they come back three more times — the next day, three to four days after, and seven days after — for MRI scans. About a week after that, after the brain has had a ‘washout’ period, they will return for their second dosing session, where they will be given whatever study compound they didn’t have during their first session.”

An independent statistician will analyse all of the results, which Nielson hopes will provide new information about the mechanisms of how exactly psilocybin changes the brain and when. 

“And, if we can figure out the time-course of this therapeutic window of opportunity, it also gives therapists a more informed protocol for how long they have after a dosing session to do integrative psychotherapy — exactly how long they have to harness the brain’s neuroplasticity to get that deeply-ingrained, pathological behaviour or belief changed.”

Nielson is seeking additional funding to grow her research team and maintain the pace of enrolment for the study, which is expected to have peer-reviewed results available by 2024. Tax-deductible donations to this study can be made to the PATH Fund through the University of Minnesota Foundation.

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Canada recommends launch of Veterans psychedelic research programme



Canada launch Veterans psychedelic research programme

A new report has been released by Canada’s Senate Subcommittee on Veterans Affairs – ‘The Time Is Now: Granting Equitable Access to Psychedelic Assisted Therapies’ – which recommends the launch of a large-scale research programme on psychedelics for Veterans’ mental health.

Emphasising that around 10 to 15% of Canadian veterans are diagnosed with post-traumatic stress disorder (PTSD), the report explores the opportunity presented by psychedelic research as a treatment for alleviating symptoms of the condition.

The Subcommittee suggests the programme should be funded by Veterans Affairs Canada (VAC) and the Department of National Defence (DND) in partnership with Health Canada, the Canadian Institutes of Health Research, and other relevant partners.

The report states: “This approach would ensure, first of all, that those veterans most likely to benefit from it are given access to treatment with the best scientific support available, and second of all, that the initial findings on the effectiveness of this treatment for veterans are either proven or qualified.”

And goes on to say: “It is the Government of Canada’s duty to assure veterans that it is doing everything in its power, immediately, to respect its solemn commitment to support, at any cost, those who chose to defend us with honour.”

Psilocybin and MDMA have already been added to Canada’s Special Access Program (SAP) which enables authorised patients to access psilocybin and MDMA-assisted therapy for conditions such as PTSD and end-of-life anxiety. 

Studies are showing that both psilocybin-assisted therapy and MDMA-assisted therapy could be potentially efficacious treatments for alleviating symptoms of PTSD in Veterans.

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However, the report notes that most clinical studies involve the general population and that Veterans often respond differently to treatments, highlighting the need for further research in the Veteran population.

The report and recommendation have been welcomed by the Psychedelic Association of Canada (PAC), which works with lawmakers, healthcare workers, educators and researchers, psychedelic practitioners, businesses and the public to gain access to psychedelic medicines for Canadians.

Jay Katz, Executive Director of the Psychedelic Association of Canada, stated: “The PAC is encouraged by the contents of the Senate Subcommittee’s report. Their acknowledgement of the potential inherent in reshaping our approach to treating mental illness is an auspicious first step. It paves the way for significantly improved outcomes.”

The organisation has highlighted that, in light of growing research, Canadian citizens have demonstrated strong support for increased access to psychedelic medicines.

To read the full report please visit:

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PAREA’s psychedelic push: improving policy for mental health innovation in Europe



Medical psychedelics policy paper launched in Europe

The Psychedelic Access and Research European Alliance (PAREA) has launched a policy paper in line with a recent meeting on medical psychedelics in the European Parliament. 

In a significant step for Europe, the MEP Action Group for the Medical Use of Psychedelics meeting took place to dicuss medical psychedelics within the EU pharmaceutical legislation framework.

PAREA launched its policy paper “Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs” in line with the event, and as a follow up to the orgainsation’s recent position statement, “Leveraging the EU Pharmaceutical Package: A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines”.

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Challenging the current paradigm that narrowly defines unmet and high unmet medical needs, PAREA argues in the policy paper that “the existing focus on life-threatening or severely debilitating conditions fails to consider the broader health and societal context.”

The paper outlines the burden created by prevalent mental health conditions including on the individual as well as healthcare systems, society and the economy, arguing that “the current criteria for unmet medical needs do not adequately account for the potential to significantly improve quality of life, especially for chronic conditions.”

As this criteria dictates what receives funding, the paper argues, “a recalibration is essential for ensuring that medicine development aligns more closely with public health priorities and needs.”

The policy paper also calls for:

  • The urgent expansion of criteria used to define high unmet medical needs to include the prevalence of conditions and their societal impact.
  • The establishment of a European Hub for Mental Health Research and Development that would unite EU institutions, member states, healthcare funders, and philanthropic organizations. 
  • For mental health to be addressed as a central pillar of sustainable development.

On the European Parliament meeting, PAREA stated: “The event, which coincided with the ongoing discussions on the revision of the EU pharma package, focused on creating a supportive regulatory environment to foster innovation in novel mental health treatments, particularly psychedelic therapies.

“The gathering underscored the urgency of addressing unmet medical needs in the EU and the potential of psychedelic therapies to offer rapid, durable improvements for conditions such as depression and PTSD.”

The organisation continued: “As the EU revises its pharmaceutical legislation, PAREA’s policy paper serves as a critical voice, advocating for a recalibrated approach that aligns medicine development with public health priorities and societal needs. It is a call to action for policymakers, healthcare professionals, and stakeholders across Europe to recognise and address the unmet needs in mental health care.”

To read the full policy paper please click here.

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Study to investigate psilocybin therapy for cancer-related depression



Study investigate psilocybin therapy for cancer-related depression

Psychedelic therapy company Sunstone Therapies has announced the start of its first study investigating multiple doses of psilocybin in the treatment of major depression disorder (MDD) in patients with cancer. 

The Phase 2 two-part study, taking place at the Bill Richards Center for Healing at the Aquilino Cancer Center, will examine the safety and efficacy of up to two 25mg doses of psilocybin in 56 patients administered at an interval of 9 to 10 weeks.

The first part of the study will administer a first dose of psilocybin in a double-blind, randomized, placebo-controlled portion, while the second part of the study will take the form of an open-label portion for patients who do not achieve MDD symptom remission after the first dose.

All study participants will be supported through the first dosing sessions by a study therapist in addition to a second therapist monitoring via video feed, and in the second session, all eligible participants will receive psilocybin 25 mg in an open-label fashion using a group session model.

Chief Medical Officer at Sunstone Therapies and Principal Investigator on the study, Paul Thambi MD, commented: “The emotional distress associated with cancer is often as significant as the physical effects, and yet oncologists have few effective treatments to tackle this important aspect of the patient experience. 

“More recently, the use of psychedelic-assisted therapy has seen renewed interest and a number of studies show a positive impact on symptoms of depression in patients with cancer, including our own open label study published in JAMA Oncology. 

“This new study includes a placebo control arm, the use of group administration, and – for the first time – multiple doses. We believe this adds significantly to the understanding of the role psilocybin-assisted therapy could play in improving patients’ lives and how it might best be delivered.”

Chief Executive Officer at Sunstone Therapies, and Clinical Investigator on the study, Manish Agrawal MD, added: “The Sunstone team has a longstanding commitment to advancing clinical research in psychedelic-assisted therapy in cancer patients, and unique depth of experience across psychedelic modalities and indications. 

“This study builds on our pioneering approach to clinical trial design: there is limited data addressing the question of whether multiple administrations of treatment doses of psilocybin in patients with cancer lead to improved efficacy. 

“We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”

The primary efficacy endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8, and secondary endpoints – which include the onset and durability of response, response rate and remission, and the effect on pain – will be used to assess parameters in both the placebo-controlled and open label study conditions.

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