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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 psychedelic-therapy more broadly. It will also deliver essential data to inform the design of a potential subsequent RCT.

This article provides a phenomenological account of the role of existential feelings in the acute and lasting effects of psychedelic therapy and attempts to elucidate phenomenologically why certain psychedelic experiences in specific contexts have the potential of providing long-term relief from mental suffering. First, we explain Matthew Ratcliffe’s theory of existential feelings and use it to highlight shared phenomenological characteristics between various mental disorders. Next, we discuss the phenomenology of oceanic feelings to specify the kind of existential feeling that is involved in acute psychedelic experiences and connect this to the existential reorientation that may occur after the use of psychedelics. Following this, we show how this framework of existential feelings allows us to (1) characterize the phenomenological process that takes during therapeutic use of psychedelics, and (2) describe various conditions required for a successful therapeutic psychedelic experience. [ABSTRACT FROM AUTHOR]

AbstractBackgroundMethodsResultsConclusionsCurrently, there are great hopes for psychedelic substances in treating psychiatric conditions and improving well-being. These substances are illegal in many countries, and we lack knowledge of how conflicting discourses shape psychedelic use in naturalistic settings. This study explores how psilocybin use is made meaningful by participants and staff at a retreat including psychedelic ceremonies aimed at personal growth.Ethnographic fieldwork was conducted at a psychedelic retreat with participants from Sweden. The material was organized using Zinberg’s model of drug, set, and setting. Theoretical work related to comparisons was utilized to elucidate how psilocybin use was distinguished from other illicit drug use.The participants’ desires to be fundamentally transformed, combined with the staff’s staging of the setting as a haven primed the participants to approach psilocybin as an inherently benevolent substance. Positive experiences during the ceremonies were attributed to the substance, and negative experiences to personal shortcomings.The staff and participants combined different discourses to define the meaning of psilocybin, all of which condemned using it for purely recreational purposes. The psilocybin use at the retreat was considered an improvement and wholly unrelated to illegal drug use, dissociating this practice from such use to establish legitimate transgression. [ABSTRACT FROM AUTHOR]

Recent research offers good reason to think that various psychedelic drugs—including psilocybin, ayahuasca, ketamine, MDMA, and LSD—may have significant therapeutic potential in the treatment of various mental health conditions, including post-traumatic stress disorder, depression, existential distress, and addiction. Although the use of psychoactive drugs, such as Diazepam or Ritalin, is well established, psychedelics arguably represent a therapeutic step change. As experiential therapies, their value would seem to lie in the subjective experiences they induce. As it is the only way for trainee psychedelic therapists to fully understand their subjective effects, some have suggested that firsthand experience of psychedelics should form part of training programs. We question this notion. First, we consider whether the epistemic benefits offered by drug-induced psychedelic experience are as unique as is supposed. We then reflect on the value it might have in regard to the training of psychedelic therapists. We conclude that, absent stronger evidence of the contribution drug-induced experiences make to the training of psychedelic therapists, requiring trainees to take psychedelic drugs does not seem ethically legitimate. However, given the potential for epistemic benefit cannot be entirely ruled out, permitting trainees who wish to gain first-hand experience of psychedelics may be permissible. [ABSTRACT FROM AUTHOR]

AbstractThe renewed interest in psychedelics as treatments for mental health disorders is often referred to as the “Psychedelic Renaissance.” This article assesses whether this resurgence truly constitutes a paradigm shift in psychiatry, as some proponents claim, or if it should be viewed as an integration of existing therapeutic approaches. We explore historical contexts, noting that psychedelics were extensively researched in the mid-20th century and argue that many of the current claims about their novelty overlook prior knowledge and research from that period. While psychedelics do introduce novel aspects, such as rapid therapeutic effects and unique modes of action, we challenge the idea of a full paradigm shift, suggesting that these developments are better understood as enhancements to existing frameworks rather than a wholesale replacement. We emphasize the importance of integrating psychedelics within a broader bio-psycho-social model of psychiatry, combining pharmacological, psychological, and contextual factors. The therapeutic potential of psychedelics in psychotherapy has previously been described as working as “nonspecific amplifiers” of psychological processes, rather than introducing entirely new mechanisms. We suggest a balanced, integrative approach that incorporates psychedelics into existing mental health care models, cautioning against “psychedelic exceptionalism” and the risk of overselling their potential as a revolutionary treatment. [ABSTRACT FROM AUTHOR]

People with cancer experience higher rates of psychological dysfunction than the general population, with extreme inequity among indigenous people. Psychedelic-assisted therapy (PAT) is a reemerging area with promising evidence as a treatment for mental health difficulties. The current study aimed to investigate the perceptions of PAT in indigenous (Māori) and non-indigenous cancer patients in Aotearoa, New Zealand. Eighty-five cancer patients (Māori n = 32, non-Māori n = 53) completed a brief anonymous survey assessing demographics, psychological factors, and awareness and perceptions of PAT. Participants were recruited online (via social media and cancer support e-mail lists) and in person at Auckland City Hospital. Maori had significantly poorer psychological well-being than non-Māori. All participants had low awareness of this novel treatment and held largely neutral attitudes. Regression analyses revealed that predictors of more favorable attitudes toward PAT included greater awareness of psychedelics, advanced cancer stage, younger age, poorer holistic well-being, greater demoralization, and prioritizing treatment effectiveness over possible risks and uncertainty. The current study provides a foundational step in exploring perceptions toward PAT in indigenous and non-indigenous groups. These results have the potential to shape future research trials investigating PAT and further highlight the importance of indigenous involvement in the psychedelic research space. [ABSTRACT FROM AUTHOR]

Background: Psychedelic substance use in ritualistic and ceremonial settings dates back as early as 8,500 BCE. Only in recent years, from the mid-20th century, we have seen the re-emergence of psychedelics in a therapeutic setting and more specifically for the treatment of addiction. This article aims to review research over the past 40 years using classic (psilocybin, lysergic acid diethylamide [LSD], dimethyltryptamine [DMT], mescaline) and atypical (ketamine, ibogaine, 5-MeO-DMT, 3,4-methylenedioxymethamphetamine) psychedelics for the treatment of addiction. Summary: We will start with an overview of the pharmacology and physiological and psychological properties of psychedelic substances from pre-clinical and clinical research. We will then provide an overview of evidence gathered by studies conducted in controlled research environments and naturalistic and ceremonial settings, while we identify the proposed therapeutic mechanisms of each psychedelic substance. Key Messages: Classic and atypical psychedelics show promise as therapeutic alternatives for the treatment of addiction, through the improvement of psychological and physiological symptoms of dependence. A more comprehensive understanding of the ancient and present-day knowledge of the therapeutic potential of psychedelics can facilitate hope for psychedelic therapeutics in the treatment of addiction, especially for individuals who have failed other conventional treatment methods. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Occupational Therapy is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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.

Introduction and aim: It is important to understand how mental health practitioners view recent findings on psychedelic-assisted psychotherapy (PAP) as there is potential this treatment may be incorporated into clinical practice. The aim of our study was to explore how psychiatrists who are not involved in psychedelic research and who are located in the European region perceive psychedelics and PAP. Methods: We conducted online semi-structured interviews with 12 psychiatry specialists and psychiatry trainees from8 European countries. Data were analyzed using a general inductive approach informed by codebook thematic analysis. Results: Based on the interviews, we developed four main themes and 14 subthemes, including (1) Psychedelics hold potential, (2) Psychedelics are dangerous, (3) Future of psychedelics is uncertain, and (4) Psychiatry is ambivalent toward psychedelics. Discussion: Our respondents-psychiatrists acknowledged the potential of PAP but remained cautious and did not yet perceive its evidence base as robust enough. Education on psychedelics is lacking in medical and psychiatric training and should be improved to facilitate the involvement of mental health experts in decision-making on PAP. [ABSTRACT FROM AUTHOR]

Abstract Psychedelic substances induce profound alterations in consciousness. Careful preparation is therefore essential to limit adverse reactions, enhance therapeutic benefits, and maintain user safety. This paper describes the development of a self-directed, digital intervention for psychedelic preparation. Drawing on elements from the UK Medical Research Council (MRC) framework for developing complex interventions, the design was informed by a four-factor model of psychedelic preparedness, using a person-centred approach. Our mixed-methods investigation consisted of two studies. The first involved interviews with 19 participants who had previously attended a ‘high-dose’ psilocybin retreat, systematically exploring their preparation behaviours and perspectives on the proposed intervention. The second study engaged 28 attendees of an ongoing psilocybin retreat in co-design workshops, refining the intervention protocol using insights from the initial interviews. The outcome is a co-produced 21-day digital course (Digital Intervention for Psychedelic Preparation (DIPP)), that is organised into four modules: Knowledge–Expectation, Psychophysical–Readiness, Safety–Planning, and Intention–Preparation. Fundamental components of the course include daily meditation practice, supplementary exercises tied to the weekly modules, and mood tracking. DIPP provides a comprehensive and scalable solution to enhance psychedelic preparedness, aligning with the broader shift towards digital mental health interventions.

Nadav Liam Modlin,1 Michael Creed,1,2 Maria Sarang,1 Carolina Maggio,1 James J Rucker,1,2 Victoria Williamson3,4 1The Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, SE5 8AF, UK; 2South London and Maudsley NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London, SE5 8AZ, UK; 3King’s Centre for Military Health Research, King’s College London, London, SE5 9RJ, UK; 4Department of Experimental Psychology, Anna Watts Building, University of Oxford, Oxford, OX2 6 GG, UKCorrespondence: Nadav Liam Modlin, The Institute of Psychiatry, Psychology and Neuroscience, King’s College London, 16 De Crespigny Park, London, SE5 8AF, UK, Email nadav.modlin@kcl.ac.ukIntroduction: Post-traumatic stress disorder (PTSD) is associated with significant patient burden. While pharmacotherapies and evidence-based psychotherapy interventions (EBPI) are effective, studies consistently highlight inadequate outcomes and high treatment dropout. Psychedelic therapy (PT) has shown preliminary promise across difficult-to-treat conditions, including MDMA-assisted therapy for PTSD, however trials of classical psychedelics in PTSD are lacking. Understanding patients’ experiences of EBPI could help promote safety in PT.Aim: To systematically review qualitative research on patients’ subjective experience of EBPI for PTSD, and of PT, and examine areas of overlap and divergence between them.Methods: Systematic literature searches for studies published between 2010 and 2023 were conducted on OVID, PubMed, Web of Science, and PsycInfo. Included were original studies in English that presented qualitative data of patient experiences of EBPI in PTSD, or PT for any indication. Extracted data from included studies were analysed using thematic synthesis. Syntheses were completed separately for EBPI and PT, before similarities and differences between the therapies were identified.Results: 40 research articles were included for review: 26 studies on EBPI for PTSD, and 14 studies on PT. EBPI studied were CBT, EMDR, CPT and PE. Psychedelic compounds studied were psilocybin, ibogaine, LSD, MDMA and ketamine, for treatment of substance use disorders, anxiety relating to physical illness, depression, and PTSD. Core themes from patient experiences of EBPI: 1) patient burden in PTSD treatment; 2) readiness; 3) key mechanisms of change; 4) psychological safety and trust. Themes identified in the review of PT: 1) indirect trauma processing; 2) reorganisation of self-narratives via processes of relatedness and identification; 3) key treatment characteristics.Conclusion: This study suggests overlap between patients’ experience of EBPI and PT in terms of key mechanisms of change, the importance of psychological safety and readiness to engage in treatment. Trauma-informed care paradigms and practices may improve safety and acceptability of PT research.Keywords: trauma, PTSD, psychotherapy, psychedelic therapy, qualitative, review

In the 2010s, psychopharmacological research and development experienced a crisis: since no genuinely new drugs for the treatment of mental illness had been successfully developed for decades, major pharmaceutical corporations decided to disinvest their neuropsychopharmacology departments. At the same time, however, one branch of psychopharmacology began to boom. The FDA declared psychedelic-assisted psychotherapy a breakthrough therapy and hundreds of start-up companies began to compete for this potentially emerging health care market. The article looks at the case of psychedelic research to examine three different responses to the innovation crisis in psychopharmacology: (1) the resumption of pharmacopsychotherapy as a half-century old but previously marginalized and discontinued practice; (2) the continuation of self-experimentation as a simultaneously repressed and revitalized method of drug development; (3) computational drug design as a cutting-edge approach currently used to create non-psychedelic psychedelics that reduce psychiatric symptoms without any mind-altering effects. These responses point to conflicting imaginaries of innovation that envisage the future of psychopharmacology and thereby provide different diagnoses of its current predicament. [ABSTRACT FROM AUTHOR]

Copyright of Kosmos is the property of Polish Copernicus Society of Naturalists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

BackgroundChronic 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).MethodsTwenty 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.DiscussionThe 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 psychedelic-therapy more broadly. It will also deliver essential data to inform the design of a potential subsequent RCT.

Introduction and aimIt is important to understand how mental health practitioners view recent findings on psychedelic-assisted psychotherapy (PAP) as there is potential this treatment may be incorporated into clinical practice. The aim of our study was to explore how psychiatrists who are not involved in psychedelic research and who are located in the European region perceive psychedelics and PAP.MethodsWe conducted online semi-structured interviews with 12 psychiatry specialists and psychiatry trainees from 8 European countries. Data were analyzed using a general inductive approach informed by codebook thematic analysis.ResultsBased on the interviews, we developed four main themes and 14 sub-themes, including (1) Psychedelics hold potential, (2) Psychedelics are dangerous, (3) Future of psychedelics is uncertain, and (4) Psychiatry is ambivalent toward psychedelics.DiscussionOur respondents-psychiatrists acknowledged the potential of PAP but remained cautious and did not yet perceive its evidence base as robust enough. Education on psychedelics is lacking in medical and psychiatric training and should be improved to facilitate the involvement of mental health experts in decision-making on PAP.

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.

Kwonmok Ko,1 Ben Carter,2 Anthony J Cleare,1,3 James J Rucker1,3 1Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, SE5 8AF, UK; 2Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, SE5 8AF, UK; 3South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Beckenham, BR3 3BX, UKCorrespondence: Kwonmok Ko, IoPPN, KCL, 16 De Crespigny Park, London, SE5 8AB, UK, Email kwon.ko@kcl.ac.ukIntroduction: In psychedelic therapy, mystical as well as challenging experience may influence therapeutic outcome. However, predictors of such experience have not been sufficiently established. Determining predictors of their intensity is, therefore, potentially beneficial in targeting psilocybin therapy for depression.Methods: In a post hoc data analysis of a Phase 1, randomised, double-blind, placebo-controlled, between-groups clinical trial, dosage, personality traits, affect, and individual data were analysed as possible clinical predictors. Eighty-nine healthy volunteers were randomised to receive a single dose of placebo, 10 mg of psilocybin, or 25 mg of psilocybin. ANOVA was used to analyse the relationship between dosage and mystical and/or challenging experience, and correlation analysis for all other variables.Results: The intensity of both mystical and challenging experience was strongly associated with higher dosage. Age was negatively correlated with intensity of challenging experience. Correlation between identified personality traits and either mystical or challenging experience was minimal, with the exception of positive correlation between neuroticism and challenging experience at higher dose. Neither positive nor negative affect indicated correlation with the intensity of either type of experience.Discussion: A limitation of this study is its post hoc, exploratory design; recommendations for further research are provided.Keywords: mystical experience, challenging experience, psilocybin, psychedelic therapy

Psychedelic therapy is, arguably, the next frontier in psychiatry. It offers a radical alternative to longstanding, mainstays of treatment, while exciting a paradigm shift in translational science and drug discovery. There is particular interest in 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT)--a serotonergic psychedelic--as a novel, fast-acting therapeutic. Yet, few studies have directly examined 5-MeO-DMT for trauma- or stress-related psychopathology, including post-traumatic stress disorder (PTSD). Herein, we present the first longitudinal case study on 5-MeO-DMT for chronic refractory PTSD, in a 23-year-old female. A single dose of vaporized bufotoxin of the Sonoran Desert Toad (Incilius alvarius), containing an estimated 10-15 mg of 5-MeO-DMT, led to clinically significant improvements in PTSD, with next-day effects. This was accompanied by marked reductions in hopelessness and related suicide risk. Improvements, across all constructs, were sustained at 1-, 3-, 6-, and 12-months follow-up, as monitored by a supporting clinician. The subject further endorsed a complete mystical experience, hypothesized to underly 5-MeO-DMT's therapeutic activity. No drug-related, serious adverse events occurred. Together, results showed that 5-MeO-DMT was generally tolerable, safe to administer, and effective for PTSD; however, this was not without risk. The subject reported acute nausea, overwhelming subjective effects, and late onset of night terrors. Further research is warranted to replicate and extend these findings, which are inherently limited, non-generalizable, and rely on methods not clinically accepted. [ABSTRACT FROM AUTHOR]

Today, practitioners of contemporary psychedelic medicine are faced with a unique challenge: supporting clients in integrating transpersonal and mystical experiences within a paradigm based on a materialistic, reductionist, and dualistic understanding of reality. Operating on assumptions of pathology and problem-solving, the Western medical model often lacks the theoretical basis to make sense of and integrate the full potentiality of psychedelic medicine. Nondualism can offer an alternative guide to engaging with and transmuting the beliefs and traumas that lie at the root of paradigms based on assumptions of separation. These frames can be deeply resourcing for both psychedelic guide and client. This article explores the challenges and limitations of the modern Western paradigm, as well as possibilities for how nondualism could be incorporated into future training of psychedelic guides. [ABSTRACT FROM AUTHOR]

Background: In the context of increasing scientific interest in the potential therapeutic use of psychedelic agents and their underlying psychotherapeutic mechanisms, we undertake the first detailed assessment of insights and life and lifestyle changes associated with ayahuasca consumption. Methods: An international cross-sectional study of ayahuasca drinkers in a variety of settings was performed (n = 8907). Bivariate analysis and multivariate linear and logistic regressions were used to explore associations between a range of covariates and insights, life changes and lifestyle changes. The least absolute shrinkage and selection operator variable selection method (LASSO) was used to select the variables most relevant for inclusion in models assessing broader wellbeing and mental health associations. Results: Insights are almost universally reported as part of the ayahuasca experience and are highly valued by drinkers and strongly predictive of subsequent beneficial life and lifestyle changes. A range of personal, vocational, religious/spiritual and health-related life changes (attributed to ayahuasca) are also commonly identified, as are various beneficial lifestyle and health behavior changes. Demographic and ayahuasca drinking variables that are predictive of such phenomena are reported, along with associations between insights, life and lifestyle changes and perceived growth in psychological wellbeing and current mental health status (Kessler 10 and SF-12 MCS). Conclusion: Insights and subsequent life and lifestyle changes appear to have a central role in the transformative effects reported by individuals consuming ayahuasca, with these occurring across contexts of use and demographic groups. [ABSTRACT FROM AUTHOR]

Simple Summary: Understanding the cellular neurobiology of psychedelics is crucial for unlocking their therapeutic potential and expanding our understanding of consciousness. This review provides a comprehensive overview of the current state of the cellular neurobiology of psychedelics, shedding light on the intricate mechanisms through which these compounds exert their profound effects. Given the significant global burden of mental illness and the limited efficacy of existing therapies, the renewed interest in these substances, as well as the discovery of new compounds, may represent a transformative development in the field of biomedical sciences and mental health therapies. Psychedelic substances have gained significant attention in recent years for their potential therapeutic effects on various psychiatric disorders. This review delves into the intricate cellular neurobiology of psychedelics, emphasizing their potential therapeutic applications in addressing the global burden of mental illness. It focuses on contemporary research into the pharmacological and molecular mechanisms underlying these substances, particularly the role of 5-HT2A receptor signaling and the promotion of plasticity through the TrkB-BDNF pathway. The review also discusses how psychedelics affect various receptors and pathways and explores their potential as anti-inflammatory agents. Overall, this research represents a significant development in biomedical sciences with the potential to transform mental health treatments. [ABSTRACT FROM AUTHOR]

Novel and traditional psychedelic medicines are attracting interest as potential treatments of mental illness. Before psychedelic therapies can be made available in culturally safe and effective ways to diverse peoples, the field must grapple with the complex legacies of colonialism and ongoing clashes between biomedical and Indigenous Ways of Knowing. This article presents results of a pilot program offering group-based therapy augmented by three sessions of ketamine at a psychedelic dose, for a group of Indigenous participants. This unique project was undertaken in partnership between Roots to Thrive and the Snuneymuxw First Nation to assess this approach's effectiveness and safety for Indigenous peoples. Thematic analysis of qualitative interviews and anonymous feedback received throughout the program from eight participants and two Elders provided rich information on participant motivations, perceived barriers, appreciated and beneficial aspects of the program, and the psychedelic experiences, as well as important directions for further improvement. In addition to challenges, participants attributed significant benefits to the program while highlighting the importance of the involvement of Indigenous team members, the incorporation of traditional approaches to healing, and the cultivation of open and authentic relationships between group participants and facilitators. We discuss important lessons learned and the essential work of reconciliation in, and beyond, psychedelic therapies. [ABSTRACT FROM AUTHOR]

The pharmacological treatment of depression consists of taking antidepressant drugs for prolonged periods; its modest therapeutic effect can often be associated with significant adverse effects, while its discontinuation can lead to relapses. Psilocybin is today a novel and breakthrough therapy for major depression. It is a natural alkaloid in Psilocybe mushrooms, which are endemic to Mexico. Research on a larger scale is lacking in various populations, including the Mexican people. This proposal contemplates the experimental design of a preclinical (toxicity and pharmacological evaluation of an extract in mice) and clinical study by including the chemical analysis of a species of Psilocybe cubensis mushroom to characterize its main constituents. The clinical study will consider the safety evaluation by exploring tolerated doses of Psilocybe cubensis by measuring pharmacokinetic parameters after oral administration in healthy adults and an open trial on a sample of patients with major depressive disorder to assess the safety and efficacy of fully characterized Psilocybe cubensis in a two-single doses treatment, (with assisted psychotherapy), compared with the traditional care model at the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz in Mexico City. This report presents the design of a research project with preclinical and clinical experimental components. [ABSTRACT FROM AUTHOR]

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.

Psychedelic therapy is, arguably, the next frontier in psychiatry. It offers a radical alternative to longstanding, mainstays of treatment, while exciting a paradigm shift in translational science and drug discovery. There is particular interest in 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT)—a serotonergic psychedelic—as a novel, fast-acting therapeutic. Yet, few studies have directly examined 5-MeO-DMT for trauma- or stress-related psychopathology, including post-traumatic stress disorder (PTSD). Herein, we present the first longitudinal case study on 5-MeO-DMT for chronic refractory PTSD, in a 23-year-old female. A single dose of vaporized bufotoxin of the Sonoran Desert Toad (Incilius alvarius), containing an estimated 10−15 mg of 5-MeO-DMT, led to clinically significant improvements in PTSD, with next-day effects. This was accompanied by marked reductions in hopelessness and related suicide risk. Improvements, across all constructs, were sustained at 1-, 3-, 6-, and 12-months follow-up, as monitored by a supporting clinician. The subject further endorsed a complete mystical experience, hypothesized to underly 5-MeO-DMT’s therapeutic activity. No drug-related, serious adverse events occurred. Together, results showed that 5-MeO-DMT was generally tolerable, safe to administer, and effective for PTSD; however, this was not without risk. The subject reported acute nausea, overwhelming subjective effects, and late onset of night terrors. Further research is warranted to replicate and extend these findings, which are inherently limited, non-generalizable, and rely on methods not clinically accepted.

This article reviews the historical protocols for the administration of "classic" psychedelics in France, from the 1920s to the 1960s. Taking a chronological approach, it investigates the way mescaline, LSD, and psilocybin were administered, the subjects involved, the route of administration, the dosage, and the epistemological context of the research. From the 1930s, the Sainte- Anne school dominated French experimentation with psychedelics, inserting these studies on "hallucinogens" into a biological conception of therapeutics, where the notion of "shock" dominated. The sessions show particularly anxious experiences, sometimes described as "torture" by the patients who underwent them. With just a few rare cases of recovery reported, these substances were not considered as medicines, but rather as tools for exploration in the context of experimental research; thought of not as psychedelics ("mind manifesters") but as psychodysleptics ("mind disruptors"). While these tools could be useful for the diagnosis of sick patients, French physicians did not manage to demonstrate clear therapeutic benefits in the use of psychedelics, perhaps because of their reluctance, in most cases, to determine an optimum dose, and also very often to appreciate the context of administration and the relationship with the patient. This article allows us to understand the reasons for the therapeutic failures reported by these early French psychedelic researchers, but also to help explain the current reluctance of French health professionals who in the face of the "psychedelic renaissance" remain strongly influenced by the very negative early representations of these substances. [ABSTRACT FROM AUTHOR]

Given the mortality, chronicity, and treatment drop-out rates observed among individuals with eating disorders (EDs), innovative approaches are needed. Ayahuasca, a psychedelic plant medicine from the Amazon, is currently being investigated. This study expands on prior exploratory research by describing the perspectives of ayahuasca ceremony leaders regarding their conceptualizations of EDs and the potential therapeutic mechanisms of action of ayahuasca for individuals with EDs. Qualitative content analysis of interviews with 15 ayahuasca ceremony leaders produced two main categories, with relevant subcategories. The first category encompassed the leaders' theories of EDs from a shamanic perspective, including that EDs are symptomatic of an underlying concern, serve a function and affect health in multiple domains. The second category described leaders' perspectives on the potential mechanisms of action of ayahuasca for EDs, including that ayahuasca facilitates "energetic healing"; helps identify, process, and integrate the "root" of the ED; promotes holistic healing; and enhances and/or reorganizes relationships. From the perspectives of ceremony leaders and consistent with previous exploratory research, ceremonial ayahuasca use may offer a potentially useful, novel and complementary intervention for EDs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The psychedelic state can be thought about as an interdependent intrapsychic, somatic, interpersonal and spiritual happening which encourages, perhaps both to the relief and dismay of those participating in the experience, the shocking and impressive emergence of one's unconscious desires and traumata's; a state which may be experienced as cathartic or healing, and as anxiety‐provoking and confusing. Often, in clinical trials investigating psychedelics in mental health conditions, these go hand in hand. Amid a renewed, at times hyperbolic, interest in psychedelics as a potential treatment for mental ill health, significant gaps of knowledge remain. Additional studies exploring the impact of the extra‐pharmacological factors and adjunct therapeutic models on treatment outcomes are needed. Drawing from psychoanalytic perspectives, this paper explores points of intersectionality between psychedelic therapy under investigation and psychoanalysis in the context of traumatic stress. To that end, the psychedelic state will be considered an attempt to make the unconscious conscious by immersing self in a bewildering waking‐dream to better tolerate reality; immersing self in a wilful state of vulnerability, to develop trust in one's agency and capacity to trust others; immersing self in an indescribable experience to learn how to redescribe, to self and to others the traumatic past. [ABSTRACT FROM AUTHOR]

Psychedelic-assisted psychotherapy with psilocybin is an emerging therapy with great promise for depression, and modern psychedelic therapy (PT) methods incorporate music as a key element. Music is an effective emotional/hedonic stimulus that could also be useful in assessing changes in emotional responsiveness following PT. Brain responses to music were assessed before and after PT using functional Magnetic Resonance Imaging (fMRI) and ALFF (Amplitude of Low Frequency Fluctuations) analysis methods. Nineteen patients with treatment-resistant depression underwent two treatment sessions involving administration of psilocybin, with MRI data acquired one week prior and the day after completion of psilocybin dosing sessions. Comparison of music-listening and resting-state scans revealed significantly greater ALFF in bilateral superior temporal cortex for the post-treatment music scan, and in the right ventral occipital lobe for the post-treatment resting-state scan. ROI analyses of these clusters revealed a significant effect of treatment in the superior temporal lobe for the music scan only. Voxelwise comparison of treatment effects showed relative increases for the music scan in the bilateral superior temporal lobes and supramarginal gyrus, and relative decreases in the medial frontal lobes for the resting-state scan. ALFF in these music-related clusters was significantly correlated with intensity of subjective effects felt during the dosing sessions. Open-label trial. Relatively small sample size. These data suggest an effect of PT on the brain's response to music, implying an elevated responsiveness to music after psilocybin therapy that was related to subjective drug effects felt during dosing. • Psychedelic therapy is a promising new treatment for depression. • Music can be used to measure effects of psychedelic therapy. • Patients brain responses to music increased after therapy. • This increase was related to the drug effects experienced during the therapy. [ABSTRACT FROM AUTHOR]

In a recent article, Messell and colleagues provide a curated list, the "Copenhagen Music Program for Psilocybin". We test their music program with an experienced Indigenous therapist/psychonaut on a 3.5 gram psilocybin journey. Based on comments provided by the Indigenous therapist, we find the program contains musical choices that evoke specific colonial and religious contexts. We also find the program psychologically and emotionally coercive, meaning it is intended to contain the experience by forcing the individual on a specific experiential pathway. We conclude the program is not suitable for Indigenous travelers and suggest that curation of a wider variety of playlists, and music more in line with traditional shamanic practices, might be a better approach to psychedelic curation. [ABSTRACT FROM AUTHOR]

Psychedelic therapy has witnessed a resurgence in interest in the last decade from the scientific and medical communities with evidence now building for its safety and efficacy in treating a range of psychiatric disorders including addiction. In this review we will chart the research investigating the role of these interventions in individuals with addiction beginning with an overview of the current socioeconomic impact of addiction, treatment options, and outcomes. We will start by examining historical studies from the first psychedelic research era of the mid-late 1900s, followed by an overview of the available real-world evidence gathered from naturalistic, observational, and survey-based studies. We will then cover modern-day clinical trials of psychedelic therapies in addiction from first-in-human to phase II clinical trials. Finally, we will provide an overview of the different translational human neuropsychopharmacology techniques, including functional magnetic resonance imaging (fMRI) and positron emission tomography (PET), that can be applied to foster a mechanistic understanding of therapeutic mechanisms. A more granular understanding of the treatment effects of psychedelics will facilitate the optimisation of the psychedelic therapy drug development landscape, and ultimately improve patient outcomes. [ABSTRACT FROM AUTHOR]

Psychedelics are psychoactive substances that receive renewed interest from science and society. Increasing empirical evidence shows that the effects of psychedelics are associated with alterations in biochemical processes, brain activity, and lived experience. Still, how these different levels relate remains subject to debate. The current literature presents two influential views on the relationship between the psychedelic molecule, neural events, and experience: The integration view and the pluralistic view. The main aim of this article is to contribute a promising complementary view by re-evaluating the psychedelic molecule-brain-experience relationship from an enactive perspective. We approach this aim via the following main research questions: (1) What is the causal relationship between the psychedelic drug and brain activity? (2) What is the causal relationship between brain activity and the psychedelic experience? In exploring the first research question, we apply the concept of autonomy to the psychedelic molecule-brain relationship. In exploring the second research question, we apply the concept of dynamic co-emergence to the psychedelic brain-experience relationship. Addressing these two research questions from an enactive position offers a perspective that emphasizes interdependence and circular causality on multiple levels. This enactive perspective not only supports the pluralistic view but enriches it through a principled account of how multi-layered processes come to interact. This renders the enactive view a promising contribution to questions around causality in the therapeutic effects of psychedelics with important implications for psychedelic therapy and psychedelic research. [ABSTRACT FROM AUTHOR]

Recent studies have demonstrated the promise of psilocybin therapies in creating positive changes for those with poor mental health across multiple diagnostic categories, including major depressive disorder (MDD), end-of-life anxiety, and obsessive-compulsive disorder (OCD). While there may be a large population that is eligible to participate in psilocybin therapy based on psychiatric diagnosis and medical clearance, little attention has been given to intrapersonal and interpersonal factors that might influence patient's readiness (i.e., eligibility and capacity) for psychedelic interventions. This paper proposes that readiness assessment includes both intrapersonal and interpersonal factors in order to improve safety, patient care, and treatment outcomes. While at the present time a reliable and valid instrument has not been developed, we propose that three specific areas of focus – patient presentation, therapeutic alliance, and patient safety – may be used to establish a patient's readiness for psilocybin therapy, thus increasing therapy optimization and personalization. • Psilocybin psychotherapy presents a novel opportunity for positive changes across many difficult to treat psychiatric illness. • Potential psychedelic therapy patients need to be thoughtfully and carefully prepared for optimal benefit. • The development of a novel scale which captures key elements which for positive outcomes would be helpful for the field. • The key elements for success include openness, motivation, affective tolerance, and the quality of the therapeutic alliance. [ABSTRACT FROM AUTHOR]

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This article reviews the historical protocols for the administration of “classic” psychedelics in France, from the 1920s to the 1960s. Taking a chronological approach, it investigates the way mescaline, LSD, and psilocybin were administered, the subjects involved, the route of administration, the dosage, and the epistemological context of the research. From the 1930s, the Sainte-Anne school dominated French experimentation with psychedelics, inserting these studies on “hallucinogens” into a biological conception of therapeutics, where the notion of “shock” dominated. The sessions show particularly anxious experiences, sometimes described as “torture” by the patients who underwent them. With just a few rare cases of recovery reported, these substances were not considered as medicines, but rather as tools for exploration in the context of experimental research; thought of not as psychedelics (“mind manifesters”) but as psychodysleptics (“mind disruptors”). While these tools could be useful for the diagnosis of sick patients, French physicians did not manage to demonstrate clear therapeutic benefits in the use of psychedelics, perhaps because of their reluctance, in most cases, to determine an optimum dose, and also very often to appreciate the context of administration and the relationship with the patient. This article allows us to understand the reasons for the therapeutic failures reported by these early French psychedelic researchers, but also to help explain the current reluctance of French health professionals who in the face of the “psychedelic renaissance” remain strongly influenced by the very negative early representations of these substances.

In a recent article, Messell and colleagues provide a curated list, the “Copenhagen Music Program for Psilocybin”. We test their music program with an experienced Indigenous therapist/psychonaut on a 3.5 gram psilocybin journey. Based on comments provided by the Indigenous therapist, we find the program contains musical choices that evoke specific colonial and religious contexts. We also find the program psychologically and emotionally coercive, meaning it is intended to contain the experience by forcing the individual on a specific experiential pathway. We conclude the program is not suitable for Indigenous travelers and suggest that curation of a wider variety of playlists, and music more in line with traditional shamanic practices, might be a better approach to psychedelic curation.

Psychedelic therapy has witnessed a resurgence in interest in the last decade from the scientific and medical communities with evidence now building for its safety and efficacy in treating a range of psychiatric disorders including addiction. In this review we will chart the research investigating the role of these interventions in individuals with addiction beginning with an overview of the current socioeconomic impact of addiction, treatment options, and outcomes. We will start by examining historical studies from the first psychedelic research era of the mid-late 1900s, followed by an overview of the available real-world evidence gathered from naturalistic, observational, and survey-based studies. We will then cover modern-day clinical trials of psychedelic therapies in addiction from first-in-human to phase II clinical trials. Finally, we will provide an overview of the different translational human neuropsychopharmacology techniques, including functional magnetic resonance imaging (fMRI) and positron emission tomography (PET), that can be applied to foster a mechanistic understanding of therapeutic mechanisms. A more granular understanding of the treatment effects of psychedelics will facilitate the optimisation of the psychedelic therapy drug development landscape, and ultimately improve patient outcomes.

Background: Psychedelic therapy shows promise for Major Depressive Disorder, especially when treatment-resistant, as well as life-threatening illness distress. The objective of this systematic review, inclusive of meta-analysis, is to examine recent clinical research on the therapeutic effects of classic psychedelics on depressive symptoms.Methods: Fourteen psychedelic therapy studies, utilising psilocybin, ayahuasca, or LSD, were systematically reviewed. For the meta-analysis, standardised mean differences were calculated for seven randomised controlled trials.Results: The systematic review indicated significant short- and long-term reduction of depressive symptoms in all conditions studied after administration of psilocybin, ayahuasca, or LSD, with psychological support. In the meta-analysis, symptom reduction was significantly indicated in three timepoints out of four, including 1-day, 1-week, and 3-5 weeks, supporting the results of the systematic review, with the exception of the 6-8 weeks follow-up point which was less conclusive.Limitations: The absence of required data for 2 studies necessitated the less precise use of graphical extraction and imputation. The small sample size in all but one study negatively affected the statistical power. None of the studies had long-term follow-up without also utilising the cross-over method, which did not allow for long-term results to be included in the meta-review.Conclusions: This review indicates an association between psychedelic therapy and significant reduction of depressive symptoms at several time points. However, the small number of studies, and low sample sizes, calls for careful interpretation of results. This suggests the need for more randomised clinical trials of psychedelic therapy, with larger and more diverse samples. [ABSTRACT FROM AUTHOR]

Ayahuasca is a psychoactive Amazonian plant brew. It is usually made from the Banisteriopsis caapi vine (Spruce ex Griseb. Morton, Malpighiaceae), which contains three primary harmala alkaloids, along with the leaves of Psychotria viridis (Ruiz et Pavon, Rubiaceae) in which the potent psychedelic dimethyltryptamine (DMT) is found. DMT-harmaloid concoctions have gained popularity in recent years, due to growing anecdotal and scientific reports of therapeutic benefits associated with their consumption. Ayahuasca is now ingested in a variety of different settings across the globe, from traditional ethnobotanical to so called "neo-shamanic" ceremonies. Furthermore, related preparations involving alternative sources of DMT and harmala alkaloids are becoming increasingly common as knowledge of ayahuasca continues to spread internationally. This article reviews the existing literature and draws on original qualitative data from a large cross-sectional study of ayahuasca drinkers, to propose a model of psychotherapeutic processes associated with the consumption of ayahuasca. We assert that it is these processes, facilitated by a range of neurobiological effects, that lead to beneficial mental health and wellbeing outcomes. Our proposed model identifies five key psychotherapeutic processes or effects inherent to the ayahuasca experience; somatic effects; introspection and emotional processing; increased Selfconnection; increased spiritual connection, and finally the gaining of insights and new perspectives. We note some important differences in these processes compared with other classic psychedelics as well as the implications of the model for the therapeutic use of ayahuasca. Improved understanding of the psychotherapeutic processes involved with the ayahuasca experience will better equip practitioners to work with this potentially transformative concoction and enable the optimization of therapeutic treatment models for potential clinical use. [ABSTRACT FROM AUTHOR]

This article provides an overview of the fields of psychosocial and integrative oncology, highlighting common psychological reactions to being diagnosed with and treated for cancer, including distress, anxiety, depression, fear of cancer recurrence and caregiver burden, as well as symptoms of fatigue, pain, and sleep disturbance. Patterns of symptomatology across the disease continuum are also discussed. Interventions targeted at treating these symptoms are reviewed, including acceptance-based and mindfulness therapies, mind-body therapies, and meaning-based approaches designed for people with advanced stages of disease, including psychedelic therapy. Common methodological issues and shortcomings of the evidence base are summarized with design recommendations, and a discussion of trends in future research including pragmatic research design, digital health interventions, and implementation science completes the article. [ABSTRACT FROM AUTHOR]

In 1991 the U.S. Congress mandated that the National Institutes of Health (NIH) form the Office of Alternative Medicine to study alternative medical therapies, especially in oncology care. Shortly after, the National Cancer Institute (NCI) created its own division of complementary and alternative medicine (Office of Complementary and Alternative Medicine). At the genesis of the field 30 years ago, what were we hoping to see accomplished by now? In this article we take a look back at milestones, shortfalls and future directions. Exciting opportunities exist to direct our established subspeciality's future directions and we have made valuable advances the field of integrative oncology over the last 30 years: 1, IV high dose ascorbate has clinical research-based applications when used concurrently with some chemotherapeutic agents. 2. Whole body, extracorporeal and locoregional hyperthermia are being applied in treating solid tumors, including brain tumors. 3. PDL-1 tumor microenvironment testing and PDL-1 inhibitor immunotherapies have surprisingly excellent outcomes in a subgroup of cancer patients. 4. Tumor DNA sequencing (resected tumor and circulating tumor DNA in blood) has led to personalized precision targeted treatments. 5. Glucose metabolism's role in cancer progression is better understood and better therapies are available (e.g., intermittent fasting, metformin). 6. Medical cannabis has a larger role in treating chemotherapy-related side effects and shows promise for anti-proliferative effects. 8. Greater understanding has been gained of the interdependence and mutual regulation of processes in psychoneuroendocrinoimmunology (PNEI). The burgeoning field of PNEI has exponentially expanded the discussion of tumorigenesis, apoptosis, and introduced to the field the investigation of more holistic approaches to immune regulation and cancer care. 8. Psychedelic-assisted psychotherapy is gaining traction especially for cancer patients facing demoralization, existential and spiritual distress, anxiety, depression and trauma related to the diagnosis and treatment of their cancer. 9. Spiritual health of cancer patients is more commonly addressed and measurable with an NIH validated scale. 10. Mind-Body therapies are efficacious for reducing cancer-related distress and are included in many cancer care programs. [ABSTRACT FROM AUTHOR]

Ayahuasca is a psychoactive Amazonian plant brew. It is usually made from the Banisteriopsis caapi vine (Spruce ex Griseb. Morton, Malpighiaceae), which contains three primary harmala alkaloids, along with the leaves of Psychotria viridis (Ruiz et Pavon, Rubiaceae) in which the potent psychedelic dimethyltryptamine (DMT) is found. DMT-harmaloid concoctions have gained popularity in recent years, due to growing anecdotal and scientific reports of therapeutic benefits associated with their consumption. Ayahuasca is now ingested in a variety of different settings across the globe, from traditional ethnobotanical to so called “neo-shamanic” ceremonies. Furthermore, related preparations involving alternative sources of DMT and harmala alkaloids are becoming increasingly common as knowledge of ayahuasca continues to spread internationally. This article reviews the existing literature and draws on original qualitative data from a large cross-sectional study of ayahuasca drinkers, to propose a model of psychotherapeutic processes associated with the consumption of ayahuasca. We assert that it is these processes, facilitated by a range of neurobiological effects, that lead to beneficial mental health and wellbeing outcomes. Our proposed model identifies five key psychotherapeutic processes or effects inherent to the ayahuasca experience; somatic effects; introspection and emotional processing; increased Self-connection; increased spiritual connection, and finally the gaining of insights and new perspectives. We note some important differences in these processes compared with other classic psychedelics as well as the implications of the model for the therapeutic use of ayahuasca. Improved understanding of the psychotherapeutic processes involved with the ayahuasca experience will better equip practitioners to work with this potentially transformative concoction and enable the optimization of therapeutic treatment models for potential clinical use.

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.

Background: Naturalistic and placebo-controlled studies suggest ayahuasca, a potent psychedelic beverage originating from Indigenous Amazonian tradition, may improve mental health, alter personality structure, and reduce alcohol and drug intake. To better understand ayahuasca's therapeutic potential and to identify factors that influence therapeutic efficacy, we conducted a naturalistic, longitudinal study of facilitated ayahuasca consumption in naïve participants using a comprehensive battery of self-report questionnaires. Materials and Methods: Ayahuasca naive individuals registering for ayahuasca ceremonies were asked to complete a range of validated questionnaires assessing mental health, alcohol/cannabis use, relationships, personality, and connection to self and spirituality, prior to and 1 month after attending an ayahuasca ceremony. Data for two mental health measures (the DASS-21 and PANAS) and acute subjective effects via the MEQ-30 were also assessed 7 days post-ceremony. Repeated measures ANOVA were used to examine pre-topost changes, and Pearson correlations explored predictors of improvement in outcomes. Results: Fifty-three attendees (32 women, 21 men) completed pre and post ayahuasca assessments with 55.6% of the sample reporting a complete mystical experience based on the MEQ-30. One-month post-ayahuasca, significant reductions were identified in depression, anxiety, stress, alcohol and cannabis use, body dissociation, accepting external influence, self-alienation, impulsivity, and negative affect/emotionality. Significant increases were identified in positive mood, self-efficacy, authentic living, extraversion, agreeableness, open-mindedness, spirituality, and satisfaction with relationships. While facets of the mystical experience held little predictive validity on outcome measures, baseline traits, particularly high negative emotionality and body dissociation, and low sense of self-efficacy, robustly predicted improvements in mental health and alcohol/cannabis use, and alterations in personality structure which are linked to better mental health. Discussion: This study suggests facilitated ayahuasca consumption in naïve participants may precipitate wide-ranging improvements in mental health, relationships, personality structure, and alcohol use. Associations between baseline traits and therapeutic improvements mark an important first step toward personalized, precision-based medicine and warrant randomized controlled trials to confirm and elaborate on these findings. Contribution Statement: Longitudinal, observational studies and randomized clinical control trials suggest ayahuasca may exert therapeutic effects on mental health and alcohol/cannabis use, and alter personality structure. However, it is unclear if improvements are diagnosis-specific and factors that predict therapeutic gains have yet to be extensively elucidated. This longitudinal, observational study examined the effects of facilitated ayahuasca consumption in naive participants on mental health, alcohol and substance use/abuse, personality traits, relationships, and connection to self and spirituality. We found wide-ranging improvements 1-month post-treatment across these domains, and identified baseline traits which predict pre-to-post changes on primary outcome measures. Improvements were not diagnosticspecific, suggesting ayahuasca may be generally efficacious. Personality traits, body dissociation, and self-efficacy were strong predictors of therapeutic improvements, marking an important first step toward personalized, precision-based medicine. Randomized controlled trials are warranted to confirm and elaborate on these findings. [ABSTRACT FROM AUTHOR]

A striking feature of psychedelics is their ability to increase attribution of truth and meaningfulness to specific contents and ideas experienced, which may persist long after psychedelic effects have subsided. We propose that processes underlying conferral of meaning and truth in psychedelic experiences may act as a double-edged sword: while these may drive important therapeutic benefits, they also raise important considerations regarding the validation and mediation of knowledge gained during these experiences. Specifically, the ability of psychedelics to induce noetic feelings of revelation may enhance the significance and attribution of reality to specific beliefs, worldviews, and apparent memories which might exacerbate the risk of iatrogenic complications that other psychotherapeutic approaches have historically faced, such as false memory syndrome. These considerations are timely, as the use of psychedelics is becoming increasingly mainstream, in an environment marked by the emergence of strong commercial interest for psychedelic therapy. We elaborate on these ethical challenges via three examples illustrating issues of validation and mediation in therapeutic, neo-shamanic and research contexts involving psychedelic use. Finally, we propose a pragmatic framework to attend to these challenges based on an ethical approach which considers the embeddedness of psychedelic experiences within larger historical and cultural contexts, their intersubjective character and the use of practices which we conceptualise here as forms of psychedelic apprenticeship. This notion of apprenticeship goes beyond current approaches of preparation and integration by stressing the central importance of validation practices based on empathic resonance by an experienced therapist or guide. [ABSTRACT FROM AUTHOR]