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The Bloom #142
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The FDA has received Lykos' (MAPS PBC) application and has given it priority review. This means a decision can be expected as soon as August this year.
In the meantime, several research articles investigated the effects of MDMA in two very different settings. The first looked at the impact of recreational use of MDMA, showing that intention predicted long-term positive outcomes (not setting). The second study compared methylone against MDMA in (rat) brain cells, showing the former to have less off-target effects.
Many studies pose different theories as to why psychedelics work. Two broad theories (at the psychological level) pit mysticism against insights. An analysis of online trip reports now argues that psychological insight predicted positive outcomes (not mystical beliefs).
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Latest Psychedelic Research
This analysis (n=240) of online trip reports examines the mechanisms behind the therapeutic potential of psychedelics, comparing metaphysical belief theory and predictive self-binding theory. Path analysis and structural equation modelling reveal that psychological insight, rather than metaphysical beliefs, uniquely predicts beneficial outcomes. Additionally, the positive effects of ego dissolution and therapeutic intent on beneficial outcomes are fully mediated by psychological insight, thereby supporting the predictive self-binding model over the metaphysical belief theory.
Related: Who Are You After Psychedelics?
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This survey study (n=766) explores the consumption habits and perceived long-term social-emotional effects of MDMA use among individuals aged 18–61, primarily from Western countries. Utilizing a K-medoids clustering algorithm, researchers identified three consumption setting types—party settings with friends (n=388), private home settings (n=132), and mixed settings (n=246)—and three intention types—euphoria and energy (n=302), self-insight (n=219), and mixed intentions (n=245). The study found that individuals in the self-insight and mixed intentions clusters reported more long-term socio-emotional benefits compared to those seeking solely euphoria and energy, with no significant differences observed between the setting clusters.
This preclinical study (in cells) investigated methylone's potential for treating PTSD, comparing it with MDMA. Methylone showed rapid antidepressant and anxiolytic effects in preclinical models, affecting gene expression related to neuroplasticity in brain areas associated with PTSD and MDD. Unlike MDMA, methylone demonstrated no off-target effects at various receptors, indicating potential higher specificity, and suggesting its potential use in treating PTSD and other neuropsychiatric disorders.
This Phase I study (n=44) investigates the safety, tolerability, pharmacokinetics, and -dynamic profile of escalating doses of SPL026 (DMT fumarate; 9-21.5mg) in psychedelic-naïve healthy participants. The RCT concludes that SPL026 was well-tolerated, showing an acceptable safety profile, with potential correlations between plasma concentration and psychometric measures.
This double-blind, placebo-controlled crossover trial (n=36) investigates the effects of two doses of MDMA (52.5-105mg/70kg) compared to both placebo and methamphetamine (20 mg) on responses to personalized social feedback in healthy adults. The study concludes that the higher dose of MDMA increases positive affective responses to social feedback, suggesting a potential mechanism by which MDMA may enhance social connection.
More new research