Riley D. Kirk, Olivia M. Uhley, Paloma Lehfeldt, C. Shields, M. Garretson, Alanna Collins, H. Wahbeh, S. Dahmer
Entheogen use is becoming increasingly popular and a potential option for treatment or adjuvant treatment for various medical conditions. Clinical studies are needed to determine the efficacy, safety, and possible role of these traditional medicines in the context of modern society and the Western medicine paradigm. The willingness of patients to participate in such studies is currently unknown.In September 2021 we implemented an anonymous, observational pilot survey to determine the general public's willingness to participate in future entheogen research. All participants were English-speaking adults and had participated in therapy or a retreat utilizing entheogens in a naturalistic setting in the last five (5) years. Participants were recruited through community outreach via email.The response rate for this data set was estimated to be 48.3% (n = 84/174). Nearly all (95.5%) participants believed this research should be done and 86.9% said they would participate in entheogen research that lasted longer than one year. A greater proportion of participants were willing to participate in remote interviews (73.5%) rather than in-person surveys (64.7%). A majority of participants (78%) also noted the importance of financial compensation for their time influencing the willingness to participate in future entheogen studies.The willingness to participate in research involving traditional entheogens is not the limiting factor in facilitating further studies. Participants held overwhelmingly positive perceptions indicating that they believed this research should be done. Future longitudinal clinical studies with financial compensation and controlled set and settings will be necessary to expand the evidence base for naturalistic entheogen use.
{"title":"Willingness to participate in entheogen use research in naturalistic settings","authors":"Riley D. Kirk, Olivia M. Uhley, Paloma Lehfeldt, C. Shields, M. Garretson, Alanna Collins, H. Wahbeh, S. Dahmer","doi":"10.1556/2054.2022.00238","DOIUrl":"https://doi.org/10.1556/2054.2022.00238","url":null,"abstract":"Entheogen use is becoming increasingly popular and a potential option for treatment or adjuvant treatment for various medical conditions. Clinical studies are needed to determine the efficacy, safety, and possible role of these traditional medicines in the context of modern society and the Western medicine paradigm. The willingness of patients to participate in such studies is currently unknown.In September 2021 we implemented an anonymous, observational pilot survey to determine the general public's willingness to participate in future entheogen research. All participants were English-speaking adults and had participated in therapy or a retreat utilizing entheogens in a naturalistic setting in the last five (5) years. Participants were recruited through community outreach via email.The response rate for this data set was estimated to be 48.3% (n = 84/174). Nearly all (95.5%) participants believed this research should be done and 86.9% said they would participate in entheogen research that lasted longer than one year. A greater proportion of participants were willing to participate in remote interviews (73.5%) rather than in-person surveys (64.7%). A majority of participants (78%) also noted the importance of financial compensation for their time influencing the willingness to participate in future entheogen studies.The willingness to participate in research involving traditional entheogens is not the limiting factor in facilitating further studies. Participants held overwhelmingly positive perceptions indicating that they believed this research should be done. Future longitudinal clinical studies with financial compensation and controlled set and settings will be necessary to expand the evidence base for naturalistic entheogen use.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48325632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Coinciding with and responding to a growing crisis in the diagnostic, explanatory and treatment systems of psychiatry, the last couple of decades have seen a growing amount of evidence regarding the therapeutic potential of psychedelic drugs to treat a variety of mental health conditions. Broadly, this crisis can be construed as that of “indivi/dualist” approaches which aim to treat patients who are construed as separated from their social and material contexts, which are taken as given. The implicit premise: the self, but not the world, is the site of therapeutic intervention. By contrast, researchers insist that psychedelic therapy functions by on producing an experience of “connectedness” to self, world, and others, which is heavily influenced by context. However, by remaining in an indivi/dualist thoughtspace, neurological and psychological perspectives betray these recurring themes. In this essay, I approach psychedelic therapy for depression through the lens of phenomenological psychiatry to take these themes seriously–a task which passes by considering experience as embodied, and therefore embedded. Starting off from an analysis of depression as a bodily detunement (disconnection), I argue that, through a process of “immersive reflection”, psychedelic therapy transforms not only the self, but patients’ sense of reality. This will allow me to answer several questions pertaining to psychedelic therapy regarding its therapeutic mechanism, why it transforms reality and not only the self, why it transforms and not merely amplifies experience, why its effects last beyond the drugs’ psychoactive duration, and in what their paradigm-shifting potential for mental health consists of.
{"title":"Psychedelic therapy as reality transformation: A phenomenological approach","authors":"Mateo Sanchez Petrement","doi":"10.1556/2054.2023.00231","DOIUrl":"https://doi.org/10.1556/2054.2023.00231","url":null,"abstract":"Coinciding with and responding to a growing crisis in the diagnostic, explanatory and treatment systems of psychiatry, the last couple of decades have seen a growing amount of evidence regarding the therapeutic potential of psychedelic drugs to treat a variety of mental health conditions. Broadly, this crisis can be construed as that of “indivi/dualist” approaches which aim to treat patients who are construed as separated from their social and material contexts, which are taken as given. The implicit premise: the self, but not the world, is the site of therapeutic intervention. By contrast, researchers insist that psychedelic therapy functions by on producing an experience of “connectedness” to self, world, and others, which is heavily influenced by context. However, by remaining in an indivi/dualist thoughtspace, neurological and psychological perspectives betray these recurring themes. In this essay, I approach psychedelic therapy for depression through the lens of phenomenological psychiatry to take these themes seriously–a task which passes by considering experience as embodied, and therefore embedded. Starting off from an analysis of depression as a bodily detunement (disconnection), I argue that, through a process of “immersive reflection”, psychedelic therapy transforms not only the self, but patients’ sense of reality. This will allow me to answer several questions pertaining to psychedelic therapy regarding its therapeutic mechanism, why it transforms reality and not only the self, why it transforms and not merely amplifies experience, why its effects last beyond the drugs’ psychoactive duration, and in what their paradigm-shifting potential for mental health consists of.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44748250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Benjamin R. Lewis, K. Byrne, J. Hendrick, E. Garland, P. Thielking, Anna Beck
Psilocybin-assisted psychotherapy has demonstrated significant promise as a treatment for depression, anxiety, and existential distress associated with serious medical illness and has generally been employed on an individual basis, which presents challenges for scaling and resource availability. There are also compelling theoretical reasons to suggest that group-based formats-if utilized in a thoughtful fashion-might offer unique or enhanced therapeutic benefits for certain conditions or populations. The HOPE trial is an IRB-approved open-label feasibility and safety pilot study of psilocybin enhanced group therapy in patients with a DSM-5 depressive disorder associated with a cancer diagnosis completed at the Huntsman Cancer Institute (HCI) in Salt Lake City, Utah (HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer). We report here qualitative survey-based data, impressions, and suggestions for group-based psychedelic-assisted therapy interventions based on our observations to inform future studies.Patients with a DSM-5 depressive disorder with an underlying cancer diagnosis were recruited from HCI by referral from oncology providers, palliative care, and social work. Following screening and consenting, 4-6 participants per cohort (with three total cohorts) were enrolled in a protocol involving 3 120 min group preparatory sessions, a single high-dose (25 mg) group psilocybin session, and 3 subsequent group integration sessions. Primary clinical outcomes are still in process of data collection and analysis. Qualitative data was gathered from patient written reports and a survey administered at 2 weeks post intervention. Qualitative reports were also gathered from the therapist team at a post-study group process session.We report here results from a qualitative survey of participant experiences with group format study design, as well as impressions and guidelines for group format and group psychotherapeutic process to inform other studies pursuing group-based interventions in psychedelic therapy. Suggestions are provided for protocol design, screening processes, space considerations, therapist team structure, group process, music, timeline, as well as potential issues and challenges.
{"title":"Group format psychedelic-assisted therapy interventions: Observations and impressions from the HOPE trial","authors":"Benjamin R. Lewis, K. Byrne, J. Hendrick, E. Garland, P. Thielking, Anna Beck","doi":"10.1556/2054.2022.00222","DOIUrl":"https://doi.org/10.1556/2054.2022.00222","url":null,"abstract":"Psilocybin-assisted psychotherapy has demonstrated significant promise as a treatment for depression, anxiety, and existential distress associated with serious medical illness and has generally been employed on an individual basis, which presents challenges for scaling and resource availability. There are also compelling theoretical reasons to suggest that group-based formats-if utilized in a thoughtful fashion-might offer unique or enhanced therapeutic benefits for certain conditions or populations. The HOPE trial is an IRB-approved open-label feasibility and safety pilot study of psilocybin enhanced group therapy in patients with a DSM-5 depressive disorder associated with a cancer diagnosis completed at the Huntsman Cancer Institute (HCI) in Salt Lake City, Utah (HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer). We report here qualitative survey-based data, impressions, and suggestions for group-based psychedelic-assisted therapy interventions based on our observations to inform future studies.Patients with a DSM-5 depressive disorder with an underlying cancer diagnosis were recruited from HCI by referral from oncology providers, palliative care, and social work. Following screening and consenting, 4-6 participants per cohort (with three total cohorts) were enrolled in a protocol involving 3 120 min group preparatory sessions, a single high-dose (25 mg) group psilocybin session, and 3 subsequent group integration sessions. Primary clinical outcomes are still in process of data collection and analysis. Qualitative data was gathered from patient written reports and a survey administered at 2 weeks post intervention. Qualitative reports were also gathered from the therapist team at a post-study group process session.We report here results from a qualitative survey of participant experiences with group format study design, as well as impressions and guidelines for group format and group psychotherapeutic process to inform other studies pursuing group-based interventions in psychedelic therapy. Suggestions are provided for protocol design, screening processes, space considerations, therapist team structure, group process, music, timeline, as well as potential issues and challenges.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42283331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Previous research has proposed that microdosing, i.e., the repeated use of sub-threshold doses of serotonergic hallucinogens, has an impact on mood by increasing emotional awareness. We propose that increased emotional awareness could translate into higher emodiversity, a balanced experience of emotions in which emotions are experienced with more similarity in intensity and duration. We examine the effect of microdosing, the day after, as well as the cumulative effect of microdosing on overall, positive and negative emodiversity.We use data collected over a period of 28 days sampled between February to June 2020 from 18 users that already had an active practice of microdosing at the start of the data collection. We assessed emotional states using ESM methods, i.e., signal-contingent sampling with triggers sent 5 times a day. The working dataset has a number of 224 observations days. We used mixed effects models to test our hypotheses.When taking into account the level of average affect, we found that during microdosing days positive and overall emodiversity were significantly lower. No evidence was found for a mediating role of the level of average affect. Higher cumulative instances of microdosing were not related to any of the emodiversity indexes. Participants experienced more “awe, wonder, or amazement”, “ashamed, humiliated, or disgraced” as well as less “joyful, glad, or happy” emotions during microdosing days.A microdosing practice may increase the centrality of certain emotions on microdosing days, resulting in a decrease in emotional diversity.
{"title":"Microdosing psychedelics – Does it have an impact on emodiversity?","authors":"I. Pop, Jannis Dinkelacker","doi":"10.1556/2054.2022.00208","DOIUrl":"https://doi.org/10.1556/2054.2022.00208","url":null,"abstract":"Previous research has proposed that microdosing, i.e., the repeated use of sub-threshold doses of serotonergic hallucinogens, has an impact on mood by increasing emotional awareness. We propose that increased emotional awareness could translate into higher emodiversity, a balanced experience of emotions in which emotions are experienced with more similarity in intensity and duration. We examine the effect of microdosing, the day after, as well as the cumulative effect of microdosing on overall, positive and negative emodiversity.We use data collected over a period of 28 days sampled between February to June 2020 from 18 users that already had an active practice of microdosing at the start of the data collection. We assessed emotional states using ESM methods, i.e., signal-contingent sampling with triggers sent 5 times a day. The working dataset has a number of 224 observations days. We used mixed effects models to test our hypotheses.When taking into account the level of average affect, we found that during microdosing days positive and overall emodiversity were significantly lower. No evidence was found for a mediating role of the level of average affect. Higher cumulative instances of microdosing were not related to any of the emodiversity indexes. Participants experienced more “awe, wonder, or amazement”, “ashamed, humiliated, or disgraced” as well as less “joyful, glad, or happy” emotions during microdosing days.A microdosing practice may increase the centrality of certain emotions on microdosing days, resulting in a decrease in emotional diversity.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49059063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article reports on integration challenges that were experienced by nine individuals who attended a three-day legal psilocybin truffle retreat in the Netherlands. The study employed a qualitative phenomenological approach, using semi-structured interviews to gain an understanding of participants' (n = 30) psilocybin experiences and their after-effects. While the study did not actively seek to measure integration issues or unexpected side effects, nine out of thirty participants (30%) spontaneously reported a post-experience integration challenge. These challenges included: mood fluctuations, ‘post-ecstatic blues’, disconnection from community, re-experiencing symptoms, spiritual bypass and perceived lack of support. Integration challenges were transient; they occurred immediately after the psilocybin experience (once the main psychedelic effects had worn off) and in the days and weeks following the retreat, and resolved with time. Integration challenges were also correlated with positive after-effects including long-term remission of significant health conditions. The experiences related in this article align with existing literature that describes the ‘spiritual emergency’ phenomenon; that is, the potential challenges that can arise after ecstatic experiences and how these challenges may be integral to the transformative potential of such experiences. We discuss the implications for psychedelic integration and harm reduction practices and for future psychedelic research.
{"title":"Psychedelic integration challenges: Participant experiences after a psilocybin truffle retreat in the Netherlands","authors":"Anna Lutkajtis, Jules Evans","doi":"10.1556/2054.2022.00232","DOIUrl":"https://doi.org/10.1556/2054.2022.00232","url":null,"abstract":"This article reports on integration challenges that were experienced by nine individuals who attended a three-day legal psilocybin truffle retreat in the Netherlands. The study employed a qualitative phenomenological approach, using semi-structured interviews to gain an understanding of participants' (n = 30) psilocybin experiences and their after-effects. While the study did not actively seek to measure integration issues or unexpected side effects, nine out of thirty participants (30%) spontaneously reported a post-experience integration challenge. These challenges included: mood fluctuations, ‘post-ecstatic blues’, disconnection from community, re-experiencing symptoms, spiritual bypass and perceived lack of support. Integration challenges were transient; they occurred immediately after the psilocybin experience (once the main psychedelic effects had worn off) and in the days and weeks following the retreat, and resolved with time. Integration challenges were also correlated with positive after-effects including long-term remission of significant health conditions. The experiences related in this article align with existing literature that describes the ‘spiritual emergency’ phenomenon; that is, the potential challenges that can arise after ecstatic experiences and how these challenges may be integral to the transformative potential of such experiences. We discuss the implications for psychedelic integration and harm reduction practices and for future psychedelic research.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44839773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Publisher's note to “Culture and psychedelic psychotherapy: Ethnic and racial themes from three black women therapists”","authors":"Anne Vallely","doi":"10.1556/2054.2022.10000","DOIUrl":"https://doi.org/10.1556/2054.2022.10000","url":null,"abstract":"","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":"56 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135643998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Although large-scale population studies have linked the use of classic psychedelics (lysergic acid diethylamide, psilocybin, or mescaline) to reduced odds of physical health problems, mental health problems, and criminal behavior, the roughly 35 million adults in the United States who have used classic psychedelics are nonetheless stigmatized in the American job market. Various federal organizations in the United States automatically reject applicants on the sole basis of prior psychedelic use, thereby practicing an open form of legal discrimination against these applicants. The present study investigates whether this discrimination can be justified based on associations between lifetime classic psychedelic use and motivationally-based workplace absenteeism.Using pooled cross-sectional data from the National Survey on Drug Use and Health (2013–2019) on 193,320 employed adults in the United States, this study tests whether lifetime classic psychedelic use predicts the number of workdays employees skipped in the last month (i.e., motivationally-based workplace absenteeism).After adjusting for sociodemographics, physical health indicators, and other substance use, no significant association between lifetime classic psychedelic use and motivationally-based workplace absenteeism is found.This study builds on classic psychedelic research that is just beginning to take work-specific outcomes into account and offers empirical justification for the elimination of arbitrary drug-based recruitment policies in the workplace.
{"title":"Recruitment discrimination of lifetime classic psychedelic users is unjustified: Evidence from employees' motivation-based workplace absenteeism","authors":"Benjamin A. Korman","doi":"10.1556/2054.2022.00240","DOIUrl":"https://doi.org/10.1556/2054.2022.00240","url":null,"abstract":"Although large-scale population studies have linked the use of classic psychedelics (lysergic acid diethylamide, psilocybin, or mescaline) to reduced odds of physical health problems, mental health problems, and criminal behavior, the roughly 35 million adults in the United States who have used classic psychedelics are nonetheless stigmatized in the American job market. Various federal organizations in the United States automatically reject applicants on the sole basis of prior psychedelic use, thereby practicing an open form of legal discrimination against these applicants. The present study investigates whether this discrimination can be justified based on associations between lifetime classic psychedelic use and motivationally-based workplace absenteeism.Using pooled cross-sectional data from the National Survey on Drug Use and Health (2013–2019) on 193,320 employed adults in the United States, this study tests whether lifetime classic psychedelic use predicts the number of workdays employees skipped in the last month (i.e., motivationally-based workplace absenteeism).After adjusting for sociodemographics, physical health indicators, and other substance use, no significant association between lifetime classic psychedelic use and motivationally-based workplace absenteeism is found.This study builds on classic psychedelic research that is just beginning to take work-specific outcomes into account and offers empirical justification for the elimination of arbitrary drug-based recruitment policies in the workplace.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41496297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Brendle, A. Ragnhildstveit, M. Slayton, Leo Smart, Sarah Cunningham, Mackenzie H. Zimmerman, P. Seli, M. Gaffrey, L. Averill, R. Robison
Ketamine and esketamine have garnered interest in both psychiatric research and clinical practice for treatment-resistant depression (TRD). In this review, we examined registered trials investigating the therapeutic use of ketamine or esketamine for TRD, with the aim of characterizing emerging trends and knowledge gaps.The ClinicalTrials.gov electronic registry and results database was queried from inception to February 5, 2022, adhering to elements of the PRISMA guideline, we evaluated trial eligibility in the qualitative synthesis. Data regarding study design, drug regimens, and measures were subsequently abstracted and descriptively analyzed.The search returned 86 records, of which 56 trials were included in the final review. The number of trials investigating ketamine and esketamine for TRD increased since 2008, with higher peaks observed in 2015 (n = 9) and 2021 (n = 9). Most trials were Phase 2 (13, 23.2%) or Phase 3 (11, 19.6%), gathering preliminary data on efficacy and/or further data on safety and efficacy with variant dosing and pharmacological approaches. By and large, trials examined ketamine and esketamine as individual versus combination treatments (45% and 25%, respectively). The Montgomery-Asberg Depression Rating Scale (MADRS) was most commonly used to assess clinical outcomes (75%).There are increasingly large-scale and late-phase trials of esketamine over ketamine for TRD, coupled with efforts to centralize evidence on these medications. Yet several trials do not assess patient characteristics that may affect treatment response, such as age, sex, and race. By understanding these design limitations, scientists and clinicians can avoid research waste and funding bodies can judiciously direct support towards high priority research.
{"title":"Registered clinical trials investigating ketamine and esketamine for treatment-resistant depression: A systematic review","authors":"M. Brendle, A. Ragnhildstveit, M. Slayton, Leo Smart, Sarah Cunningham, Mackenzie H. Zimmerman, P. Seli, M. Gaffrey, L. Averill, R. Robison","doi":"10.1556/2054.2022.00234","DOIUrl":"https://doi.org/10.1556/2054.2022.00234","url":null,"abstract":"Ketamine and esketamine have garnered interest in both psychiatric research and clinical practice for treatment-resistant depression (TRD). In this review, we examined registered trials investigating the therapeutic use of ketamine or esketamine for TRD, with the aim of characterizing emerging trends and knowledge gaps.The ClinicalTrials.gov electronic registry and results database was queried from inception to February 5, 2022, adhering to elements of the PRISMA guideline, we evaluated trial eligibility in the qualitative synthesis. Data regarding study design, drug regimens, and measures were subsequently abstracted and descriptively analyzed.The search returned 86 records, of which 56 trials were included in the final review. The number of trials investigating ketamine and esketamine for TRD increased since 2008, with higher peaks observed in 2015 (n = 9) and 2021 (n = 9). Most trials were Phase 2 (13, 23.2%) or Phase 3 (11, 19.6%), gathering preliminary data on efficacy and/or further data on safety and efficacy with variant dosing and pharmacological approaches. By and large, trials examined ketamine and esketamine as individual versus combination treatments (45% and 25%, respectively). The Montgomery-Asberg Depression Rating Scale (MADRS) was most commonly used to assess clinical outcomes (75%).There are increasingly large-scale and late-phase trials of esketamine over ketamine for TRD, coupled with efforts to centralize evidence on these medications. Yet several trials do not assess patient characteristics that may affect treatment response, such as age, sex, and race. By understanding these design limitations, scientists and clinicians can avoid research waste and funding bodies can judiciously direct support towards high priority research.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2023-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43643461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Atoian, Harry C. R. Bowles, Sarah Gerhke, Suzy Atoian, N. Bowles, D. Thangathurai
The COVID-19 pandemic exacerbated pre-existing high-levels of physician stress and burnout1. In order to help treat frontline colleagues who were diagnosed with acute stress disorder, we chose a non-psychedelic, ketamine micro-dose treatment strategy for symptom management.We provided care virtually, and all patients were prescribed sublingual ketamine once daily. Each patient was evaluated using the NIH-PROMIS CAT assessments for stress, depression, anxiety, and PTSD via a remote, HIPAA compliant patient self-reporting platform. Progress was tracked and assessed against a baseline value obtained prior to the start of treatment. Patient progress was evaluated at a 4–6-week interval. Patients did not report any significant side effects to the treatment regimen.100% (25/25) of patients experienced improved anxiety, 92% (23/25) experienced improved stress, 96% (24/25) experienced improved PTSD, and 91% (20/22) experienced improved depression.While we cannot draw definitive conclusions from the association demonstrated by this data, we believe these results demonstrate that further research into the efficacy of daily, short-term ketamine micro-doses for treatment of acute stress disorder is warranted.
{"title":"Micro-dose, macro-impact: Leveraging psychedelics in frontline healthcare workers during the COVID-19 pandemic","authors":"A. Atoian, Harry C. R. Bowles, Sarah Gerhke, Suzy Atoian, N. Bowles, D. Thangathurai","doi":"10.1556/2054.2022.00227","DOIUrl":"https://doi.org/10.1556/2054.2022.00227","url":null,"abstract":"The COVID-19 pandemic exacerbated pre-existing high-levels of physician stress and burnout1. In order to help treat frontline colleagues who were diagnosed with acute stress disorder, we chose a non-psychedelic, ketamine micro-dose treatment strategy for symptom management.We provided care virtually, and all patients were prescribed sublingual ketamine once daily. Each patient was evaluated using the NIH-PROMIS CAT assessments for stress, depression, anxiety, and PTSD via a remote, HIPAA compliant patient self-reporting platform. Progress was tracked and assessed against a baseline value obtained prior to the start of treatment. Patient progress was evaluated at a 4–6-week interval. Patients did not report any significant side effects to the treatment regimen.100% (25/25) of patients experienced improved anxiety, 92% (23/25) experienced improved stress, 96% (24/25) experienced improved PTSD, and 91% (20/22) experienced improved depression.While we cannot draw definitive conclusions from the association demonstrated by this data, we believe these results demonstrate that further research into the efficacy of daily, short-term ketamine micro-doses for treatment of acute stress disorder is warranted.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2022-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47782423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The hallucinogenic drug psilocybin is being widely tested in humans for the treatment of psychiatric disorders. Psilocybin and other psychedelics are proposed to work through serotonin 2a (5-HT2a) receptors, which are tightly linked to immune function. The purpose of the present study was to assess the effects of a single dose of psilocybin on a panel of cytokines, chemokines, and peptides in the short term (24 h) and long term (seven days) in female rats.Female rats were given a dose of psilocybin (20 mg kg−1, i.p.} or a dose of synthetic interstitial fluid. At 24 h, the control group and one group of rats were anesthetized, and blood was withdrawn by intracardiac puncture. In a third group of rats, blood was withdrawn after seven days. Serum was analyzed by a separate lab (Eve Laboratories, Calgary, Canada) for 27 immunomodulators.Serum levels of IL-1β, TNF-α, MCP-1, IP-10, G-CSF, IFN-γ, IL-10, IL-13, and leptin were significantly increased compared to controls after 24 h and were increased further after 7 days. Most of the other assays showed this same pattern of increase, although not statistically significant.Psilocybin induces the release of multiple immune factors, consistent with a generalized activation of the immune system, which can persist for at least seven days after a single dose. These findings may relate to the mechanism of action. The implications of these findings require additional research to determine how these finding relate to the clinical effects of psilocybin.
{"title":"Effects of a single dose of psilocybin on cytokines, chemokines and leptin in rat serum","authors":"G. Bove, D. Mokler","doi":"10.1556/2054.2022.00230","DOIUrl":"https://doi.org/10.1556/2054.2022.00230","url":null,"abstract":"The hallucinogenic drug psilocybin is being widely tested in humans for the treatment of psychiatric disorders. Psilocybin and other psychedelics are proposed to work through serotonin 2a (5-HT2a) receptors, which are tightly linked to immune function. The purpose of the present study was to assess the effects of a single dose of psilocybin on a panel of cytokines, chemokines, and peptides in the short term (24 h) and long term (seven days) in female rats.Female rats were given a dose of psilocybin (20 mg kg−1, i.p.} or a dose of synthetic interstitial fluid. At 24 h, the control group and one group of rats were anesthetized, and blood was withdrawn by intracardiac puncture. In a third group of rats, blood was withdrawn after seven days. Serum was analyzed by a separate lab (Eve Laboratories, Calgary, Canada) for 27 immunomodulators.Serum levels of IL-1β, TNF-α, MCP-1, IP-10, G-CSF, IFN-γ, IL-10, IL-13, and leptin were significantly increased compared to controls after 24 h and were increased further after 7 days. Most of the other assays showed this same pattern of increase, although not statistically significant.Psilocybin induces the release of multiple immune factors, consistent with a generalized activation of the immune system, which can persist for at least seven days after a single dose. These findings may relate to the mechanism of action. The implications of these findings require additional research to determine how these finding relate to the clinical effects of psilocybin.","PeriodicalId":34732,"journal":{"name":"Journal of Psychedelic Studies","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2022-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42918139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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