Tema: Psilocybin Clinical Trials Approved by FDA

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  1. #1
    Un Viejo Conocido Avatar de Yyy
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    Smile Psilocybin Clinical Trials Approved by FDA

    Es algo que se veia venir. Algo de lo que se viene hablando cada vez mas fuerte y seguramente un exito asegurado
    (alga la redundancia ). Lamentablemente el tiempo que lleva este tipo de ensayos es largo y recien seria el primero. Pueden ver el caso de MDMA por ej. Mientras tanto sigamosla activando desde el autocultivo para beneficio de todos.

    The United States Food and Drug Administration has approved Compass Pathways’s clinical trials directed to using psilocybin for treating depression, namely “Treatment Resistant Depression,” aka “TRD.”

    In a statement released by Compass Pathways, 216 patients with treatment-resistant depression will take part in a phase two clinical trial across 12 to 15 research sites in North America and Europe, which will start in the U.K. later this month. The clinical trial is a dose-ranging study, which aims to determine the best dose of psilocybin to use for treating TRD.

    The U.S. FDA’s approval of Compass’s trial represents a significant departure from the the governments position that psilocybin, cannabis, and MDMA are “substances, or chemicals … with no currently accepted medical use and a high potential for abuse.” See DEA Drug Scheduling. For many, this is perceived as the first step in correcting mistakes made in scheduling several promising drug treatments.

    Compass Pathways’s Clinical Trials
    As we reported previously, Compass Pathways is partnering with Worldwide Clinical Trials in conducting the first clinical trials for treating “Treatment Resistant Depression” (“TRD”) with psilocybin-assisted psychotherapy. See Financial Times, September 20, 2017.

    The first round of clinical trials are focused on “Dose Finding,” which means determining the correct dosing regimen for treating TRD. The clinical trial participants “will be given synthetic psilocybin” in trials designed to determine the best dose of psilocybin–whether 1 mg, 10 mg, or 25 mg – is most effective.

    Notably, Compass’s study is measuring the effects of a known amount of a known drug. Accordingly, the Compass studies already represent a significant improvement over existing psilocybin dosing methods, which rely on eating magic mushrooms. (Magic mushrooms contain many active ingredients in variable concentrations). See “Compass Pathways is NOT giving Magic Mushrooms to Depressed Patients.”

    Significant Step Forward in Establishing Baseline Benefits

    The effects provided from “magic mushrooms” arise from combining multiple different active ingredients to arrive at an “entourage effect.”
    To understand the full potential of psilocybin derivatives, the community must first understand how each piece works in isolation. Compass Pathways is leading the charge towards understanding the first piece.
    These studies by Compass Pathways represent a significant first step towards creating psilocybin based formulations. Improving our understanding of pure synthetic psilocybin treatments provides a baseline for studying formulations that leverage the full potential of magic mushrooms. See Entourage Effect (discussing synergistic benefits of psilocybin derivatives and drawing an analogy to cannabis research). Akin to cannabis, once scientists have a baseline for how one component works in isolation, the community can quantify the benefits of specific combinations having optimized benefits and/or reduced side-effects.
    Fuente: https://psilocybintechnology.com/psi...proved-by-fda/
    Última edición por Yyy; 23/08/2018 a las 20:19

  2. #2
    Un Viejo Conocido Avatar de v.js
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    Che que zarpado. Me gusta que se esté apuntando a éste tipo de cosas. Más allá de que éstos ensayos lleven un tiempito, por algo se empieza, y si tiene resultados (que no creo que sean negativos) va a crecer exponencialmente.
    El Exceso y/o Abuso de Drogas y Alcohol es Perjudicial Para tu Salúd... ¡Cuidate, Nadie Lo Hará Por Vos!

  3. #3
    Un Viejo Conocido Avatar de Melkor
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    Grata noticia

    Pensaba que iba a tener que esperar más para escuchar esto. Ahora nos queda la larga espera. Al MDMA le dieron la categoria de "breakthrough treatment" y se supone que la fase 3 de los ensayos clinicos tendria que concluir en 2021, despues de eso entra al mercado como psicofármaco. Cuanto tardarán con la psilocybina?

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