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Extension of MDMA PTSD study to be hosted by Numinus

An extension of the MAPS-sponsored trial exploring MDMA-assisted therapy for PTSD will be hosted by Numinus Wellness. 

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Extension of MDMA PTSD study to be hosted by Numinus

For the multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX) sponsored by MAPS, Numinus will manage two new clinics in Montreal and Vancouver.

The Montreal and Vancouver sites in MAPPUSX will continue to study the safety and efficacy of MDMA in treating severe PTSD, under the leadership of MAPS Public Benefit Corporation (PBC) as study organiser. 

Numinus will also financially support costs relating to therapists who deliver the therapeutic intervention in Numinus clinics during the trial.

The Vancouver and Montreal psychedelic-assisted psychotherapy clinics were previously used to conduct MAPS PBC’s earlier study, MAPP1, in which 88 per cent of participants experienced a clinically meaningful reduction in symptoms and 67 per cent no longer qualified for a PTSD diagnosis. 

See also  Data shows combination psilocybin therapy effective for TBI and PTSD

Numinus vice president and therapist for the Montreal site of the trial, Dr Joe Flanders, VP, Psychology, commented: “We are honoured to host the Canadian sites of the MAPPUSX trial as we continue to examine the important findings around MDMA-assisted therapy for PTSD.

“Our clinical and research teams are well positioned to implement MAPS’ research and, ultimately, to work with MAPS on the translation of research findings into mainstream clinical practice. We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future.”

“We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites” added Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, Ph.D..  

“As we get closer to our goal of making MDMA-assisted therapy a reality, it is critical that we work with clinics who will advance making this treatment widely accessible in real-world settings.”

Numinus CEO, Payton Nyquvest, commented: ”We are thrilled that our two new locations, which are purpose-developed for psychedelic-assisted therapy, regulatorily compliant and leading in industry standards, can be used to help advance this crucial work on psychedelic medicine. 

“We look forward to deepening our collaboration with MAPS while expanding the resources and solutions available to those suffering from PTSD.”

A total of 25 Numinus-affiliated therapists have gone through the MAPS training programme for delivery of MDMA-assisted therapy, a number of which will have roles in the trial. The trial will be open to eligible participants who were previously enrolled in the placebo arm of the MAPP1 parent study or who were not able to receive treatment due to COVID-19 restrictions.

Securing the Canadian sites will allow Numinus to expand its clinical activities in Quebec and BC, including its ketamine-assisted psychotherapy programme.

Research

Psychedelics for addiction research gets $2.7m grant

The grant will fund research to investigate the efficacy of psychedelics for treating a variety of addiction disorders.

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Psychedelics for addiction research gets $2.7m grant

The University of California, Davis (UC Davis) and the University of Colorado Anschutz Medical Campus have received a $2.7m (~£2.15m) grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to research psychedelics.

The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. 

With previous research having shown that psychedelic drugs can rewire parts of the brain involved in depression, substance abuse and post-traumatic stress disorder, David Olson, associate professor in the departments of Chemistry, and Biochemistry and Molecular Medicine at UC Davis, is searching for similar effects among compounds without the hallucinogenic effects of drugs like LSD. 

He calls these compounds psychoplastogens, for their ability to modify the brain.

See also  World’s first study on ketamine for behavioural addiction now complete

Olson commented: “I’m very excited that NIDA is recognising the potential that psychoplastogens might have for patients with substance use disorders.

“This grant will help us to understand the basic mechanisms by which these compounds impact addiction, and hopefully develop more effective and better-tolerated treatments.”

Olson’s work is part of a growing focus on psychedelics research at UC Davis and UC Davis Health. His lab has synthesised hundreds of molecules related to psychedelics in the search for new drug therapies. 

One such molecule, tabernanthalog, or TBG, produces both rapid and sustained anti-addictive effects in rodent models of heroin and alcohol self-administration.

The research will include mechanistic studies to understand how TBG impacts addiction and the development of new compounds with psychoplastogenic effects, he said. The team will use high-throughput screening to test for efficacy, safety and treatment potential. Promising compounds will undergo additional animal testing at CU Anschutz.

Delix Therapeutics, a startup founded by Olson, is also investigating non-hallucinogenic psychoplastogens for treating depression, anxiety and related disorders but is not involved in the project.

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World’s first study on ketamine for behavioural addiction now complete

Awakn Life Sciences will now carry out a larger study following positive results.

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World’s first ketamine for behavioural addiction study now complete

Awakn Life Science’s study exploring the use of ketamine as a treatment for Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior is now complete.

Ketamine may provide a new treatment solution for behavioural addictions, according to the study researchers.

Gambling Disorder, Internet Gaming Disorder and Binge Eating Disorder affect up to 450 million, 235 million and 100 million people across the globe respectively. Compulsive Sexual Behavior affects up to 350 million people. 

Awakn, which highlights that the current standard of care for these conditions is poor, investigated ketamine as a new treatment approach for behavioural addictions by opening a window in which the brain can make new connections to change behaviour. 

See also  Awakn initiates first ever ketamine treatment study for gambling addiction

The findings indicated the desired effects via potentially novel mechanisms – results that merit a larger study and further exploration, which Awakn is now initiating.

The study was led by Professor Celia Morgan, Awakn’s head of ketamine-assisted therapy, Professor of psychopharmacology at the University of Exeter, and an internationally respected expert in the therapeutic use of ketamine. 

Morgan commented: “These promising early findings may suggest a new treatment solution in behavioural addictions, which are growing rapidly across the globe, and as yet, are a completely unmet treatment need. 

See also  Groundbreaking ketamine study receives approval for expansion

“The team are excited to be starting these new significant studies which promise to bring considerable innovation to the field.”

According to Awakn, the study also supports its Intellectual Property (IP) strategy and existing filed patent applications.

Awakn CEO, Anthony Tennyson commented: “This study is hugely encouraging and gave us all the data we could have hoped for. Critically, it also showed us that a larger study is merited, and we will now pursue this. 

“For such a huge cohort of over a billion people to be suffering with no pharmacological treatment available to them, is unacceptable and we will strive to deliver therapies to patients who are in desperate need.”

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New partnership to harness digital tools to enhance psychedelic care

Beckley Psytech is entering into a partnership with Empatica to carry out one of the world’s first trials with psychedelics and digital tools.

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New partnership to advance personalised psychedelic patient care

Beckley Psytech and Empatica are collaborating to support the collection and analysis of data in Beckley Psytech’s future clinical trials.

The partnership will capture behavioural and physiological signals and predictive biomarkers in Beckley Psytech’s upcoming Phase 2 clinical trials. To do this, Beckley Psytech will harness Empatica’s medical-grade EmbracePlus wearable and software.

The trials will be evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

See also  Beckley Psytech doses first patients in novel 5-MeO-DMT study

Empatica, Inc., specialises in medical wearables and digital biomarkers, offering continuous, passive and unobtrusive monitoring for patients with neurological conditions. Beckley has stated the partnership is the latest step in its digital strategy to develop personalised treatment programmes for patients in need. 

The digital enhancement of the psychedelic treatment pathway aims to support patients before, during and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse.

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “As we look to enhance the safety and effectiveness of our psychedelic treatments with patient-centric digital tools, this partnership with Empatica accelerates our strategy of creating an integrated treatment model to ensure patients are fully supported through the treatment journey. 

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

“We are thrilled to be working with Empatica, a pioneering digital health company, through our upcoming clinical trials and look forward to further evolving our understanding of how digital tools can support and potentially improve outcomes for patients with neurological and psychiatric conditions.”

Beckley Psytech aims to establish a complete, end-to-end personalised psychedelic treatment programme, combining advanced digital phenotyping capabilities, such as those developed by Empatica, with psychedelic-assisted psychotherapy. 

The company has stated that this approach will allow clinicians to provide patients with continuous access to personalised therapy support beyond their treatment, delivering potentially improved outcomes and safety for patients and healthcare systems.

Matteo Lai, CEO of Empatica, commented: “We couldn’t be more excited to collaborate with Beckley Psytech on this important project, especially since over the past two years, we have witnessed how critical mental health and depression have become globally. 

“The potential of psychedelic treatments in the field can help millions of patients, and Empatica is honoured to contribute its technology in one of the world’s first trials with psychedelics and digital tools, to advance these novel therapies with targeted help and better engagement.”

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