Psychedelic News Roundup: Cybin Receives FDA Breakthrough Status & New Study Shows Natural Psilocybin Outperforms Synthetic

TIn this week’s Psychedelic News Roundup, we detail a new study that shows natural psilocybin extracts may be more beneficial than synthetic variants for mental health applications. Other news includes Utah’s passage of a new MDMA and psilocybin therapy bill, several fresh scientific studies, Cybin’s FDA Breakthrough Status, and more.

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Natural Psilocybin Extract Shows Superiority Over Synthetic in Mental Health Therapy

Published in Jama Psychiatry, a new study from the Hebrew University-Hadassah Medical Center has unveiled that psilocybin-containing mushroom extract outperforms its synthetic counterpart in enhancing synaptic plasticity, offering a new horizon in treating psychiatric disorders. Led by Orr Shahar and Dr. Alexander Botvinnik, under the guidance of Dr. Tzuri Lifschytz and Prof. Bernard Lerer, the research presents compelling evidence that natural psychedelic compounds could lead to a better understanding of the differences between natural and synthetic psychedelic compounds.

The study’s findings highlight the mushroom extract’s potent and enduring impact on synaptic plasticity, suggesting that the extract’s natural composition provides unique therapeutic benefits not replicable by synthetic psilocybin alone. The research also points to the mushroom extract’s distinct metabolic profile, indicating its unique influence on oxidative stress and energy production pathways, which could underpin its enhanced therapeutic effects.

Addressing the challenge of producing consistent natural extracts for medicinal use, the study emphasizes the feasibility of controlled mushroom cultivation. This approach could ensure the replicability of extracts with a consistent compound profile, overcoming a major hurdle in integrating natural psychedelic compounds into Western medicine. The findings not only advocate for the therapeutic superiority of natural psilocybin extracts but also underscore the potential for these nature-based solutions to fill a critical gap in psychiatric care, offering hope to millions who have yet to find relief through conventional treatments.

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Psychedelics and Mental Health in Adolescents: A Twin Study’s Insights

As detailed by Neuroscience News, a comprehensive study published in JAMA Psychiatry explores the nuanced relationship between psychedelic drug use and the onset of psychotic or manic symptoms in adolescents, with a particular focus on genetic predispositions to mental health disorders. Conducted by Otto Simonsson, Ph.D., and colleagues, the research delves into the experiences of 16,255 adolescent twins from the Swedish Twin Registry, aiming to discern the potential mental health implications of naturalistic psychedelic use during adolescence. The study’s findings suggest a complex interplay between psychedelic use, genetic vulnerability, and the manifestation of psychotic or manic symptoms.

The research reveals that adolescents who reported using psychedelics showed a lower incidence of psychotic symptoms compared to their counterparts who did not use these substances, even after adjusting for the use of other drugs. However, the study also indicates a significant association between psychedelic use and increased manic symptoms in individuals with a higher genetic risk for schizophrenia or bipolar I disorder. This dual outcome underscores the potential mental health risks and benefits associated with psychedelic use in adolescents, particularly in the context of genetic predispositions to certain psychiatric conditions.

The implications of these findings are profound, suggesting that while psychedelic use may offer some protective effects against psychotic symptoms in the general adolescent population, it could exacerbate manic symptoms in those genetically predisposed to specific mental health disorders. The study’s authors advocate for a cautious interpretation of these results, emphasizing the need for further research to fully understand the therapeutic and adverse effects of psychedelics on adolescent mental health. This research contributes to a growing body of evidence that seeks to inform harm reduction strategies and guide future investigations into the safe and effective use of psychedelics in psychiatric treatment.

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Personality Traits: Shaping the Psychedelic Experiences

As reported by Psychedelic Support, the interplay between personality traits and the effects of psychedelic substances is a burgeoning field of study, offering valuable insights for both users and practitioners in the realm of psychedelic therapy. Sam Woolfe’s exploration into this domain highlights the significant impact that individual personality characteristics can have on the nature and quality of psychedelic experiences. This understanding is crucial for tailoring harm reduction strategies and optimizing the preparation for psychedelic journeys, ensuring a safer and more beneficial experience for users.

Research, such as the study conducted by Petter Grahl Johnstad, underscores the correlation between the Big Five personality traits—extraversion, agreeableness, conscientiousness, emotional stability/neuroticism, and openness—and the propensity to use psychedelics. Notably, individuals high in openness, a trait associated with the pursuit of new experiences and a curiosity about the world, are more likely to seek out and positively respond to psychedelic experiences. This trait also predisposes individuals to more profound experiences of love, inner visions, and encounters with non-ordinary beings during psychedelic journeys. Conversely, those with high extraversion tend to experience a deeper connection with others rather than encountering transcendental entities, reflecting their predisposition for social interaction.

The study further reveals how personality traits can influence the likelihood of experiencing challenging aspects of psychedelic trips. For instance, individuals with high emotional stability are less prone to fear. In contrast, those high in neuroticism may face increased anxiety and fear, highlighting the need for careful consideration of set and setting, especially for those with certain personality predispositions. Additionally, traits such as risk-taking behavior and sensory processing sensitivity can significantly affect the intensity of psychedelic experiences and the likelihood of ego dissolution, suggesting that personalized dosing and support could enhance the therapeutic potential of psychedelics.

This nuanced understanding of the relationship between personality and psychedelic experiences not only aids in better preparing individuals for their journeys but also underscores the importance of individualized approaches in psychedelic therapy. By acknowledging and accommodating the diverse ways people may respond to these substances based on their personality traits, practitioners can offer more effective and compassionate care, potentially unlocking profound healing and transformative experiences for those they guide.

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Cybin’s Psychedelic Molecule CYB003 Receives FDA Breakthrough Designation for Major Depressive Disorder Treatment

Cybin Inc., has achieved a significant milestone with the FDA’s Breakthrough Therapy Designation (BTD) for CYB003, a novel deuterated psilocybin analog aimed at treating Major Depressive Disorder (MDD). This designation, the first of its kind for an adjunctive psychedelic therapy for MDD, promises an expedited review pathway and closer guidance from the FDA, potentially shortening the drug development timeline significantly. The BTD is a testament to CYB003’s potential to fill a critical gap in MDD treatment, offering hope to millions who have found little relief in existing medications.

In a Phase II trial, CYB003 demonstrated robust and sustained improvement in depression symptoms four months post-treatment, with 75% of participants achieving remission after two 16mg doses. This impressive outcome, marked by a mean 22-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score, underscores the molecule’s potential to provide a long-lasting solution to those battling MDD. The trial’s success paves the way for a pivotal Phase III multinational study slated for mid-2024, moving CYB003 closer to regulatory approval and commercial availability.

The FDA’s BTD for CYB003 accelerates Cybin’s development program and highlights the urgent need for innovative treatments in the mental health domain. With a significant portion of the population unresponsive to current antidepressants, CYB003 represents an advancement in psychiatric medicine.

Discover How Cybin’s Groundbreaking Molecule, CYB003, Is Setting New Standards in Mental Health Treatment With Its FDA Breakthrough Therapy Designation for Major Depressive Disorder.