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Discover the world’s first VR-assisted psychedelic therapy

A new partnership hopes to facilitate patients in Europe to access a quality of mental health care “that leapfrogs traditional approaches”.

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Discover the world’s first VR-assisted psychedelic therapy

Enosis Therapeutics, OVID Clinics and the MIND Foundation for Psychedelic Research have joined together to implement the world’s first in-clinic application of Virtual Reality (VR) combined with psychedelic-assisted psychotherapy.

Patients will now have the opportunity to receive psychedelic-assisted psychotherapy integrated with Enosis’ science-backed virtual technology protocols.

Enosis collaborated with the Swinburne University of Technology in Australia In June 2022, announcing positive results from the world’s first study on the synergistic application of VR in psychedelics. 

See also  German government ministry funds psilocybin study with €2.6m

The preliminary results showed that Enosis’ bespoke VR scenarios, combined with a guided psychedelic experience, generated high levels of acceptance and satisfaction. The positive results from this first study have led Enosis’ to begin offering VR scenarios with psychedelic-assisted therapy inside OVID Clinics.

Psychedelic Health spoke to Enosis, OVID and the Mind Foundation about the partnership to find out more.

Psychedelics and VR

With patient enrolment now in progress, Enosis and OVID say the new partnership shows further proof that VR is a powerful technology for enhancing mental health, highlighting that VR capabilities and protocols are gaining strong momentum in psychedelics research and clinical settings.

The teams told Psychedelic Health: “Ketamine-assisted psychotherapy follows the protocol developed in house by the medical staff at OVID Clinics and is provided by medical officers and psychotherapists at OVID. 

“One arm of the ketamine psychotherapy program also uses Virtual Reality scenario, designed and licensed to OVID Clinics by Enosis Therapeutics. AnchoringVR™ is be used in both the dosing and the integration sessions, along with one VR introductory practice session during preparation phase, to familiarise the patient with use of VR technology. 

See also  Partnership to launch world’s first in-clinic VR psychedelic-therapy

“The treatment is offered to patients at the moment and is a part of official OVID programme, through commercial partnership with Enosis. Patients who express willingness to contribute to scientific research can also opt to participate in the research study through OVID-Enosis academic partnership.”

Beyond offering the in-clinic protocol in Berlin, Enosis and OVID will be gathering data for a research collaboration aiming to investigate the synergistic effects of psychedelic and digital interventions in hopes that the results demonstrate better therapeutic patient outcomes and enhance overall patient wellbeing.

“This research uses questionnaires to document clinical outcomes and psycho-emotional experiences of patients diagnosed with depression, following ketamine psychotherapy programme and VR-assisted ketamine psychotherapy programme,” they added.

The group says that the main objectives of this study, achieved through both quantitative and qualitative (interview) data, are to:

1) Examine the acceptability, feasibility and appropriateness of the combined use of VR and ketamine in psychotherapy treatment of depression (three outcome measures: acceptability, appropriateness and feasibility).

2) Document clinical outcomes and psycho-emotional experiences of patients undergoing VR-facilitated ketamine psychotherapy treatment for depression (Hamilton Depression Scale, Beck Depression Inventory, State-trat anxiety inventory).

3) Compare the effects of ketamine psychotherapy treatment and the VR-facilitated ketamine psychotherapy treatment (psychedelic integration scales, working alliance inventory, the empowerment scale, state mindfulness scale and affect checklist)

Results so far

The therapy uses bespoke VR scenarios – AnchoringVR™ – which the team highlights has been previously studied in combination with psilocybin at a psychedelic retreat in the Netherlands, in collaboration with Swinburne University and Psychedelic Society Belgium.

“Following the completion of the retreat, all four participants felt that the use of VR intervention was acceptable, appropriate and feasible during the psychedelic retreat,” they said. 

“Three out of four participants gave a maximum total score for all three measures. Subjective accounts suggest that no negative impact or major discomfort has been experienced as a result of using VR within the retreat setting.

“Data on state mindfulness and on affect, along with interview answers point to the capacity of Anchoring VR to remind of the thoughts and insights that emerged during the psychedelic experience, to evoke strong emotions during the integration process that are similar to those experienced during the psychedelic session, and that Anchoring VR is perceived to be useful in the integration process.”

How VR is integrated into psychedelic therapy 

The partnership says the VR treatment sees patients receive medical and psychiatric screening sessions, along with preparation sessions including one VR practice, ketamine sessions including AnchoringVR™ and integration sessions including AnchoringVR™, as well as follow-up sessions.

Enosis’ AnchoringVR™ contains partially scenic and partially abstract content, is static, fully interactive and with very low intensity stimuli such as low lights, no rapidly changing shapes or colours, say the team. 

The VR headset and hand-held controllers are applied in a seated or semi-seated position and there is no music. The team highlight that specifications for the VR were determined by software providers, Enosis Therapeutics Pty Ltd, based on previous research and clinical applications of therapeutic VR scenarios as well as research on mystical-type experiences and psychedelic experiences.

“In dosing sessions: AnchoringVR™ is a multisensory self-expression scenario, which is used by the patients to create multisensory records of thoughts, feelings or insights that emerged during their ketamine session,” the team said. 

“Patients use the VR to create audio recordings or visual expressions, building a memory library of their psychedelic experience. VR is applied immediately after the ASC experience with ketamine.

“In integration sessions: AnchoringVR™ preserves the therapeutic framework, psychotherapeutic approach and the exchange between the patient and the therapist; the main difference to standard talk therapy is that at a portion of that engagement is extended through multisensory expressions which represent what is being discussed, and audio recordings that are generated by the patient to aid patient notes. 

“Patients can listen to those audio expressions and inspect those visual expressions that were created during experiential sessions and generate new ones during integration process. VR is applied throughout every integration session, either for a portion of it or through the entire session.”

Helping patients in Europe

Research into psychedelics is showing increasing promise for the treatment of mental health conditions, however the team highlights that innovation in psychedelics has been largely focussed on drug development.

They note that increased focus should be put on supporting patients before and after psychedelic experiences.

“While necessary to ensure that the industry is able to scale, this offers far less direct benefit to the patient. Patient outcomes rely not only on the induction of an altered state of consciousness, which, quite frankly, most of the currently available substance do well already,” they said.

“Most patients need support before and following the experience, through an adequately designed and implemented psychotherapy program. At this point, we can’t know what such ‘adequate’ program looks like. We have only relied on therapeutic methods which have been designed for cognitive-heavy approaches, not for an altered state of consciousness. Through inclusion of immersive therapy frameworks patients get the choice of continuing the emotional, explorative, experiential engagement also during the psychotherapy process. 

“They also get to preserve their experience and their therapeutic engagement permanently, through the VR model and audio-visual recordings they generate, as these can be shared both as VR files but also as 360 exports and audio files, that can be accessed even from their phone. Introducing this model into therapeutic care also allows therapists to learn more experiential approaches in addition to talk therapy methods.

“Ovid Clinics, has from the beginning, been interested in supporting and introducing innovation that leads directly to improved patient outcomes. Their reputation in Europe puts them as an ideal candidate to demonstrate the standard for high-quality care and thus open the eyes of the European ecosystem to the possibilities that a judicious introduction of technology can do to optimise their practice.

“We trust that this will lead to patients in Europe being able to access a quality of care that leapfrogs traditional approaches and is more in line with a health care delivery model of the next decade than that of the past.”

Digital support tools for psychedelic therapy

Enosis told Psychedelic Health that it will now be further exploring partnerships with research institutions and clinics globally that may be interested in using this psychotherapy tool in combination with other psychedelic medicines. 

Enosis said: “We want to ensure access to high quality care and give everyone an equal chance for it- hence our pricing model has a sliding scale to make it accessible for anyone, and fees can be waived if data collection is of interest.

“As for our local market in Australia, in line with the recent TGA rescheduling of psilocybin and MDMA, Enosis has committed to giving out access to its software for free to any Australian therapist looking to start working with psychedelics. 

“Through it’s immersive, emotional, experience based mechanisms of action, AnchoringVR™ acts as a therapeutic framework in itself, and can be an effective, reliable, easily scalable bridge, that can help to guide therapists who are trying to acclimatise themselves to working with altered states of consciousness.

“Our focus is on the human elements of psychedelic therapy and how we can optimise these factors whilst allowing the psychedelic experience to proceed undisturbed.

“It is vital for us to distinguish that what we are building is a psychotherapy tool in VR which supports both the patient and the therapist in their journey. It is not a replica of a psychedelic experience nor simply a nice setting for the psychedelic journey; it is not meant to replace the drug nor is it meant to exist in silo as ‘meditation app’. 

“In fact, it is a mental health tool that, whilst inspired by the novel way of processing and healing that psychedelics offer, it is not limited to use with psychedelics. It can be used in any mental health or well-being treatment that wants to expand its experiential components.

“Psychotherapy has been getting increasingly reductive and the move to zoom therapy and app-led prescribing is a further demonstration of this. 

“Our goal is to return therapy to being involved, engaged and immersive, ensuring the therapeutic frame and presence is maximised so that the insights from psychedelic sessions are fed into the most optimal psychotherapeutic container in which to integrate them into psycho-behavioural outcomes.”

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Canada recommends launch of Veterans psychedelic research programme

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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.

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: sencanada.ca/en/info-page/parl-44-1/veac-psychedelic-therapies/

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

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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”.

See also  PAREA launches psychedelics manifesto for mental health in Europe

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

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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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