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BACKGROUND: Chronic pain is a leading cause of disability worldwide. Fibromyalgia is a particularly debilitating form of widespread chronic pain. Fibromyalgia remains poorly understood, and treatment options are limited or moderately effective at best. Here, we present a protocol for a mechanistic study investigating the effects of psychedelic-assisted-therapy in a fibromyalgia population. The principal focus of this trial is the central mechanism(s) of psilocybin-therapy i.e., in the brain and on associated mental schemata, primarily captured by electroencephalography (EEG) recordings of the acute psychedelic state, plus pre and post Magnetic Resonance Imaging (MRI). METHODS: Twenty participants with fibromyalgia will complete 8 study visits over 8 weeks. This will include two dosing sessions where participants will receive psilocybin at least once, with doses varying up to 25mg. Our primary outcomes are 1) Lempel-Ziv complexity (LZc) recorded acutely using EEG, and the 2) the (Brief Experiential Avoidance Questionnaire (BEAQ) measured at baseline and primary endpoint. Secondary outcomes will aim to capture broad aspects of the pain experience and related features through neuroimaging, self-report measures, behavioural paradigms, and qualitative interviews. Pain Symptomatology will be measured using the Brief Pain Inventory Interference Subscale (BPI-IS), physical and mental health-related function will be measured using the 36-Item Short Form Health Survey (SF-36). Further neurobiological investigations will include functional MRI (fMRI) and diffusion tensor imaging (changes from baseline to primary endpoint), and acute changes in pre- vs post-acute spontaneous brain activity - plus event-related potential functional plasticity markers, captured via EEG. DISCUSSION: The results of this study will provide valuable insight into the brain mechanisms involved in the action of psilocybin-therapy for fibromyalgia with potential implications for the therapeutic action of

BackgroundPsilocybin is a serotonin type 2A (5-HT2A) receptor agonist and naturally occurring psychedelic. 5-HT2A receptor density is known to be associated with body mass index (BMI), however, the impact of this on psilocybin therapy has not been explored. While body weight-adjusted dosing is widely used, this imposes a practical and financial strain on the scalability of psychedelic therapy. This gap between evidence and practice is caused by the absence of studies clarifying the relationship between BMI, the acute psychedelic experience and long-term psychological outcomes.MethodData were pooled across three studies using a fixed 25 mg dose of psilocybin delivered in a therapeutic context to assess whether BMI predicts characteristics of the acute experience and changes in well-being 2 weeks later. Supplementing frequentist analysis with Bayes Factors has enabled for conclusions to be drawn regarding the null hypothesis.ResultsResults support the null hypothesis that BMI does not predict overall intensity of the altered state, mystical experiences, perceptual changes or emotional breakthroughs during the acute experience. There was weak evidence for greater 'dread of ego dissolution' in participants with lower BMI, however, further analysis suggested BMI did not meaningfully add to the combination of the other covariates (age, sex and study). While mystical-type experiences and emotional breakthroughs were strong predictors of improvements in well-being, BMI was not.ConclusionsThese findings have important implications for our understanding of pharmacological and extra-pharmacological contributors to psychedelic-assisted therapy and for the standardization of a fixed therapeutic dose in psychedelic-assisted therapy.

Under de två senaste decennierna har forskningen och intresset för psykedelisk terapii västvärlden växt. Vid en snabb översikt av fältet och det narrativ som framträder så återkommer konceptet integration i litteraturen som en viktig beståndsdel i den psykedeliska terapin. Beskrivningar av vad integration som aktivitet är, kan eller bör vara skiljer sig åt i den vetenskapliga litteraturen. Till vår vetskap har dock ingen tidigare sammanställning gjorts för integrationens roll och betydelse inom modern klinisk forskning. Att en sådan sammanställning görs är av särskild vikt som grund för eventuell framtida behandling. Detta är därmed syftet för denna uppsats. Mer specifikt ämnades följande frågeställningar att besvaras: (I) Hur beskrivs interventioner som efterföljer den psykedeliska sessionen? (II) Vad syftar den efterföljande interventionen till? (III) Hur motiverar studierna sin metod? Frågeställningen besvarades via en kartläggande litteraturöversikt och tillhörande metodologi. Litteratursökningen genererade 228 resultat där totalt 17 studier inkluderades. Datan analyserades via en basal manifest innehållsanalys. Resultatet visade att integration är minimalt beskriven i de inkluderade studierna samt att dessa har olika beskrivningar för integrationsprocessen. Vidare skiljde sig beskrivningarna av syftet med det integrativa samtalet åt i de olika studierna. Slutligen saknades en redogörelse för teoretisk grund och diskussion kring integrationen som del av behandlingen. Nyckelord: psykedelisk terapi, integration, kartläggande litteraturöversikt, In the last two decades, the research and interest in psychedelic therapy has grownin the western world. In a quick overview of the field and the narrative that emerges, the concept of integration is described in the literature as an important component of psychedelic therapy. Descriptions of what integration as an activity is, can or should be, differ in the scientific literature. However to our knowledge no previous compilation has been made of the role and importance of integration in modern clinical research. That such a compilation is made is of particular importance as a basis for possible future treatment. This is thus the purpose of this essay. More specifically, the following questions were intended to be answered: (I) How are interventions following the psychedelic session described? (II) What is the purpose of the subsequent intervention? (III) How do the studies justify their method? The questions were answered via a scoping review and associated methodology. The literature search generated 228 results in which a total of 17 studies were included. The data was analyzed via a basic manifest content analysis. The result showed that integration is minimally described in the included studies and that these have different descriptions of the integration process. Furthermore, the descriptions of the purpose of the integrative conversation differed in the various studies. Finally, an account of the theoretical basis and discussion of integration as part of the treatment was missing. Key words: psychedelic therapy, integration, scoping review

In light of high-profile cases of sexual assault and other unethical conduct by therapists, recent clinical research involving psychedelic drugs has generally mandated the video recording of therapy sessions. In this paper, I address a gap in the literature by investigating ethical issues related to video recording in the unique context of psychedelic therapy sessions. I begin by summarizing the important benefits and risks related to video recording. I then examine ethical concerns about mandatory recording of psychedelic therapy sessions from a patient perspective and argue that these concerns must be taken seriously by clinicians and researchers. I also examine the view that video recording is essential for clinician safety. Given the legitimacy of concerns from both perspectives, I outline some basic informed consent considerations that could generate dialogue around potential patient concerns and defend the option to opt-out for both patients and clinicians. In conclusion, I underscore the importance of further critical bioethical inquiry and qualitative research regarding video recording practices in the context of psychedelic-assisted therapies., Après des cas très médiatisés d’agressions sexuelles et d’autres comportements contraires à l’éthique de la part de thérapeutes, la recherche clinique récente sur les drogues psychédéliques a généralement rendu obligatoire l’enregistrement vidéo de toutes les séances de thérapie. Dans cet article, j’examine les questions éthiques liées à l’enregistrement vidéo dans le contexte unique des séances de thérapie psychédélique. Je commence par résumer les avantages et les risques importants liés à l’enregistrement vidéo, puis ensuite les préoccupations éthiques concernant l’enregistrement obligatoire des séances de thérapie psychédélique du point de vue du patient, et je soutiens que ces préoccupations doivent être prises au sérieux par les cliniciens et chercheurs. J’examine également le point de vue selon lequel l’enregistrement vidéo est essentiel pour la sécurité des cliniciens. Acceptant la légitimité des préoccupations des deux points de vue, j’expose quelques considérations de base sur le consentement éclairé qui pourraient générer un dialogue autour des préoccupations potentielles des patients. Je défends l’option de refuser, tant pour les patients que pour les cliniciens. En conclusion, je souligne l’importance de poursuivre l’enquête bioéthique critique et la recherche qualitative concernant les pratiques d’enregistrement vidéo dans le contexte des thérapies assistées par les psychédéliques.

RationalePsychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.ObjectiveIn this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.ResultsAlthough some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants' expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies are discussed in the context of study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.ConclusionIncorporating the recommended design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increases the ability to discern treatment-specific effects of psychedelic therapy.

Recent evidence shows significant potential for therapies involving psychedelic substances such as psilocybin and MDMA to improve clinical outcomes for patients experiencing various mental disorders. However, research to date focuses almost exclusively on adults. I argue that adolescents should be included in research into psychedelic therapies. First, I demonstrate the pressing need for novel interventions to address the growing mental health burden of adolescents, and I draw on empirical evidence to show that research into psychedelic therapies presents an opportunity to address this shortfall. Secondly, I argue that psychedelics pose low risk to young patients, particularly relative to existing psychiatric medications. I then address two major concerns specific to adolescent contexts. First, I address the risks of using psychedelic substances at earlier stages of physiological and cognitive development. I note that the lack of understanding of the risks underscores the need for including adolescents in research. I then address the added complexity of consent in the adolescent context. I highlight some additional concerns that should be addressed in an “enhanced” informed consent process for adolescents and defend the view that capable adolescents should be able to consent to psychedelic interventions. I ultimately hold that including adolescents in emerging psychedelic research has the potential to substantiate innovative treatments that could improve their clinical outcomes, long-term mental health and quality of life., Des données récentes montrent que les thérapies faisant appel à des substances psychédéliques telles que la psilocybine et la MDMA ont un potentiel important pour améliorer les résultats cliniques des patients souffrant de divers troubles mentaux. Cependant, les recherches menées à ce jour se concentrent presque exclusivement sur les adultes. Je soutiens que les adolescents devraient être inclus dans la recherche sur les thérapies psychédéliques. Tout d’abord, je démontre le besoin urgent de nouvelles interventions pour répondre au fardeau croissant de la santé mentale des adolescents, et je m’appuie sur des preuves empiriques pour montrer que la recherche sur les thérapies psychédéliques offre une opportunité de répondre à ce manque. Deuxièmement, je soutiens que les psychédéliques présentent un faible risque pour les jeunes patients, en particulier par rapport aux médicaments psychiatriques existants. J’aborde ensuite deux préoccupations majeures spécifiques aux contextes adolescents. Premièrement, j’aborde les risques liés à l’utilisation de substances psychédéliques à des stades précoces du développement physiologique et cognitif. Je note que le manque de compréhension de ces risques souligne la nécessité d’inclure les adolescents dans la recherche. J’aborde ensuite la complexité supplémentaire du consentement dans le contexte des adolescents. Je souligne certaines préoccupations supplémentaires qui devraient être abordées dans un processus de consentement éclairé “amélioré” pour les adolescents, et je défends l’idée que les adolescents capables devraient être en mesure de consentir à des interventions psychédéliques. Je soutiens finalement que l’inclusion des adolescents dans la recherche émergente sur les psychédéliques a le potentiel de justifier des traitements innovants qui pourraient améliorer leurs résultats cliniques, leur santé mentale à long terme et leur qualité de vie.

Objective: The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has positioned itself against medically controlled patient access (at this current time) to 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin-assisted therapies in its Therapeutic Use of Psychedelic Substances Clinical Memorandum, May 2020. The main reason given by the RANZCP for its stance is safety concerns. Methods: Every reference in the clinical memorandum (CM) was checked against the original publications used by RANZCP to justify its position. In addition, the search engines Google Scholar, PubMed, ScienceDirect, the Multidisciplinary Association for Psychedelic Therapies (MAPS) website, the Therapeutic Goods Administration (TGA) website, relevant Australian and New Zealand legislation were searched for pertinent and up-to-date- information. Results: There is no scientific or medical evidence from the last 70 years to suggest that either psilocybin or MDMA, when administered as an adjutant to therapy in a controlled clinical setting, are linked to either mental illness or negative health outcomes. On the contrary, MDMA and psilocybin have been shown to be safe, non-toxic, non-addictive, and efficacious when administered in a medically-controlled clinical environment. All associated risks are apparent in an uncontrolled setting. Conclusion: The RANZCP’s position is based on outdated, irrelevant, misinterpreted, and misinformed evidence. With the recent positive media coverage of the efficacy of these medicines when used as an adjunct to therapy, there is an intrinsic risk of self-medication or underground therapy. This means that any medical discussion must also purvey the ethical responsibilities and social duties associated with these substances.

RATIONALE:Recent studies have supported the safety and efficacy of psychedelic therapy for mood disorders and addiction. Music is considered an important component in the treatment model, but little empirical research has been done to examine the magnitude and nature of its therapeutic role. OBJECTIVES:The present study assessed the influence of music on the acute experience and clinical outcomes of psychedelic therapy. METHODS:Semi-structured interviews inquired about the different ways in which music influenced the experience of 19 patients undergoing psychedelic therapy with psilocybin for treatment-resistant depression. Interpretative phenomenological analysis was applied to the interview data to identify salient themes. In addition, ratings were given for each patient for the extent to which they expressed "liking," "resonance" (the music being experienced as "harmonious" with the emotional state of the listener), and "openness" (acceptance of the music-evoked experience). RESULTS:Analyses of the interviews revealed that the music had both "welcome" and "unwelcome" influences on patients' subjective experiences. Welcome influences included the evocation of personally meaningful and therapeutically useful emotion and mental imagery, a sense of guidance, openness, and the promotion of calm and a sense of safety. Conversely, unwelcome influences included the evocation of unpleasant emotion and imagery, a sense of being misguided and resistance. Correlation analyses showed that patients' experience of the music was associated with the occurrence of "mystical experiences" and "insightfulness." Crucially, the nature of the music experience was significantly predictive of reductions in depression 1 week after psilocybin, whereas general drug intensity was not. CONCLUSIONS:This study indicates that music plays a central therapeutic function in psychedelic therapy.

Due to the illegality of psychedelic substances, and despite proven efficiency, people suffering from various psychiatric illnesses and disorders are unable to receive potentially life-changing psychedelic therapy. With the recent technological development of computer-mediated realities, designers and developers now have the opportunity to digitally recreate such treatments. Through practical application along with the review of literature and conferences, this study aims to analyse the potential of mediated realities to convincingly simulate psychedelic therapy. Augmented reality (AR) and modulated realities (ModR) such as modified and diminished reality show insufficient evidence for practical use in simulated psychedelic therapy. Augmented virtuality (AV), mixed reality (MR), virtual reality (VR) and modulated virtuality (ModV) contain a range of characteristics fundamental to potentially simulating mind manifesting psychedelic therapy. However, mediated reality in general appears to be extraneous for practical use in mind loosening psychedelic therapy. Currently, virtual reality (VR) shows the greatest potential for healing, trauma release, personal growth and exploration of the psyche by simulating closed-eye psychedelic experiences through adding virtual information via an HMD. Accordingly, the author of this study has proposed a proof of concept (POF) for a neurofeedback driven VR experience which simulates aspects of both mind loosening and mind manifesting psychotherapy. This POF is intended to simulate the transformation of phosphenes into complex geometric pattern based hallucinations. With further development in this field, one day people suffering from various mental conditions might be able to receive safe, accessible and legal forms of simulated psychedelic therapy.

Předložená diplomová práce se zabývá možným využitím psychedelické terapie za účelem léčby drogové závislosti. V teoretické části práce mapuji základní termíny týkající se problematiky drogové závislosti a psychedelické zkušenosti. Hlavním tématem této části práce je zaostření na využití vybraných způsobů navození psychedelické zkušenosti za účelem terapie s drogově závislými. Praktická část je tvořena kvalitativním výzkumem. Jejím cílem je za pomoci hloubkových rozhovorů postihnout u vybraných respondentů subjektivní vnímání přínosů psychedelické terapie ve vztahu k jejich problému s drogami. Na zachycení subjektivního vnímání respondentů jsou zaměřeny i dílčí cíle týkající se drogové anamnézy, motivace k léčbě drogové závislosti a důvodů pro výběr psychedelické terapie. Výpovědi respondentů shrnuji do kazuistických studií. V příloze je pro ilustraci přiložen audiovizuální záznam s výpověďmi respondentů popisující své autentické zkušenosti s psychedelickou terapií., This thesis deals with the possible use of psychedelic therapy for the treatment of drug addiction. The theoretical part describes fundamental terms relating to the issue of drug addiction and psychedelic experiences. The main theme of this part is to focus on the use of selected methods of inducing psychedelic experience to therapy with drug addicts. The practical part includes qualitative research. Its goal with the help of depth interviews with selected respondents describe the subjective perception of the benefits of psychedelic therapy in relation to their drug problem. To capturing perceptions of respondents are focused even sectional aims regarding the drug anamnesis, motivation for treatment of drug addiction and the reasons for the selection of psychedelic therapy. Interviews with respondents are summarized to case studies. To illustrate i attached the audiovisual record with interviews of respondents describing their authentic experience with psychedelic therapy., Fakulta filozofická