Psychedelic-assisted Therapy Research Articles

Anxiety and Affective Symptoms Related to the Use of Classic Psychedelics: A Systematic Review.

There is a large and rapidly growing body of literature investigating the therapeutic effects of classic psychedelics in affective and anxiety disorders, but very few studies have examined the inverse of this, that is, the potential for psychedelics to inflict anxiety and affective symptoms. A systematic literature search was performed and 39 papers were included in the final review to qualitatively synthesize the current literature on anxiety and affective disorders related to the use of classic psychedelics. Persisting disorders were less frequent but generally occurred in individuals who presented with several risk factors (overdose, polydrug use, unstructured recreational setting, psychosocial stress, personal/familial psychiatric histories). When psychedelics were administered in clinical studies under the framework of psychedelic-assisted therapy, the incidence of enduring anxiety and affective symptoms was low. In most cases, acute transient anxiety emerged and resolved during the dosing session without the need for additional treatment interventions. The nuance of such cases is discussed, shedding light on the role of emotional catharsis in the therapeutic process. Several suggestions are proposed to enhance patient safety including strengthening the therapeutic alliance, ensuring adequate mental preparation, acclimating to high doses and providing on-going therapeutic support.

Moving psychedelic-assisted therapies from promising research into routine clinical practice: Lessons from the field of implementation science.

Psychedelics (e.g., 3,4-Methylenedioxymethamphetamine [MDMA], lysergic acid diethylamide [LSD], psilocybin) are molecules that have the potential to produce rapid therapeutic effects when paired with psychotherapy. Randomized clinical trials of psychedelic-assisted psychotherapy (PAT) have shown promising results for post-traumatic stress disorder (PTSD), depression, and substance use disorders. The U.S. Food and Drug Administration has acknowledged the promise of PAT, signaling potential approval of psilocybin-assisted therapy for depression by 2026. Given this timeline, implementation scientists must engage with PAT researchers, policymakers, and practitioners to think critically about bringing these promising new treatments into routine practice settings while maintaining quality and safety. This commentary aims to initiate a dialogue between implementation scientists and PAT researchers and practitioners on addressing these questions with a lens toward equity. Specifically, we discuss how the field of implementation science can support PAT stakeholders to accelerate the translational process from research into practice, focusing specifically on safety-net settings (i.e., Federally Qualified Health Centers and Veterans Affairs health systems) that serve historically marginalized populations. We use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework to illustrate five critical areas where implementation science can help move PAT from research into real-world practice. For each RE-AIM dimension, we highlight ways the field of implementation science can contribute tools (e.g., implementation strategies), methodologies (e.g., pragmatic hybrid implementation-effectiveness trials), and approaches (community-based participatory research) for establishing the safety, effectiveness, and accessibility of PAT for historically underserved communities.

Systematic Review of the Effect of Psychedelic-Assisted Therapy on Attitudes Toward Death, Life, and Spirituality on Symptoms of Distress, Depression, and/or Anxiety in Patients with Life-Threatening Illness

Systematic Review of the Effect of Psychedelic-Assisted Therapy on Attitudes Toward Death, Life, and Spirituality on Symptoms of Distress, Depression, and/or Anxiety in Patients with Life-Threatening Illness

Memory, trauma, and self: Remembering and recovering from sexual abuse in psychedelic-assisted therapy

AbstractBackground and AimsThis article examines the therapeutic potential of psilocybin in addressing Post-Traumatic Stress Disorder as the result of sexual abuse. PTSD is a prevalent form of mental distress resistant to most conventional treatment methods.MethodsThrough an in-depth analysis of the narratives of two individuals with longstanding, treatment-resistant mental health conditions, who participated in a weeklong group-based psychedelic retreat involving psilocybin, the study unveils the intricate interplay between psychedelic-assisted therapy, memory, and narrative in the healing process.ResultsThe research findings suggest that beyond the commonly acknowledged therapeutic effects of psychedelic drugs, psilocybin can facilitate the retrieval of repressed or forgotten traumatic memories, allowing for conscious awareness, recognition, and reconciliation. A noteworthy aspect of the healing progression observed is the re-narration of one's identity and biographical circumstances following the recovery of unresolved traumatic memories.ConclusionsThis study underscores the importance of memory and self-narrative in the therapeutic landscape of psychedelic-assisted therapy for trauma. The article concludes by advocating for continued exploration in future research regarding the complex dynamics of memory and self-narrative in the healing journey within psychedelic science and trauma studies.

Updates in palliative care of gynecologic oncology patients

Purpose of review This review assesses the impact of early integration of palliative care and the disparities that exist among patients with gynecologic malignancies. It also highlights the recent advances in symptom management, goals of care communication, and end of life care. Recent findings Although palliative care has been utilized earlier, there are still barriers to its integration both nationally and worldwide, manifesting as predominantly late hospice referrals and aggressive care at the end of life. However, there are increasing efforts to promote earlier integration and discussion around goals of care through multidisciplinary approaches. Apart from symptom burdens, patients with gynecologic malignancies experience financial toxicity that impact various aspects of their lives, leading to potentially harmful choices to mitigate costs. A growing area of interest in palliative care is the realm of psychedelic-assisted therapy, which has shown benefits in treating advanced cancer patients with depression. Summary While significant strides have been made in incorporating palliative care earlier, continued research in palliative care is needed to address symptomatic and psychosocial suffering worldwide.

Attitudes toward psychedelics and psychedelic-assisted therapy among potential mental health service users and the general population in Australia.

Despite rapid advances in psychedelic sciences and the increasing number of countries legalizing psychedelics for the treatment of mental illnesses, the attitudes, knowledge and readiness of both mental health consumers and the general population remain largely unknown. A cross-sectional survey was conducted among Australians, targeting individuals with mental illness as potential mental health service users. A sub-sample of individuals free of mental illness was also surveyed to assess attitudes in the general population. Participants completed the Attitudes on Psychedelics Questionnaire, the Basic Knowledge of Psychedelics Test and a questionnaire by Corrigan et al. to capture attitudes toward psychedelic therapy by mental health service users. Of the 502 respondents, 64.5% self-identified as having a mental illness. A significant proportion favored legalizing psychedelics for medical use (43%) and were open to their use (52.4%), yet fewer viewed their effects positively (24%) or considered them safe (33%). Most participants reported to be psychedelic naive (61%). Participants with mental illness had significantly more experience with psychedelics than participant free of mental illness (44.1% vs 29.7%). Experience, perceived knowledge and actual knowledge significantly predicted attitudes toward legalization, effects, risks and openness to psychedelics. While a large proportion of Australians are in favor of legalizing psychedelics for medical purposes, concerns about safety remain. People with self-identified mental illness, those with previous recreational psychedelic experience and those with greater knowledge of psychedelics were more likely to have positive attitudes toward psychedelics and psychedelic-assisted therapy.

Harnessing Pharmacogenomics in Clinical Research on Psychedelic-Assisted Therapy.

Psychedelics have recently re-emerged as potential treatments for various psychiatric conditions that impose major public health costs and for which current treatment options have limited efficacy. At the same time, personalized medicine is increasingly being implemented in psychiatry to provide individualized drug dosing recommendations based on genetics. This review brings together these topics to explore the utility of pharmacogenomics (a key component of personalized medicine) in psychedelic-assisted therapies. We summarized the literature and explored the potential implications of genetic variability on the pharmacodynamics and pharmacokinetics of psychedelic drugs including lysergic acid diethylamide (LSD), psilocybin, N,N-dimethyltryptamine (DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine and 3,4-methylenedioxymethamphetamine (MDMA). Although existing evidence is limited, particularly concerning pharmacodynamics, studies investigating pharmacokinetics indicate that genetic variants in drug-metabolizing enzymes, such as cytochrome P450, impact the intensity of acute psychedelic effects for LSD and ibogaine, and that a dose reduction for CYP2D6 poor metabolizers may be appropriate. Furthermore, based on the preclinical evidence, it can be hypothesized that CYP2D6 metabolizer status might contribute to altered acute psychedelic experiences with 5-MeO-DMT and psilocybin when combined with monoamine oxidase inhibitors. In conclusion, considering early evidence that genetic factors can influence the effects of certain psychedelics, we suggest that pharmacogenomic testing should be further investigated in clinical research. This is necessary to evaluate its utility in improving the safety and therapeutic profile of psychedelic therapies and a potential future role in personalizing psychedelic-assisted therapies, should these treatments become available.

Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response.

Psychedelic-assisted therapy (PAT) is permitted in Switzerland under its limited medical use program. Data from patients in this program represent a unique opportunity to analyze the real-world practice of PAT. This study compared the subjective effects of lysergic acid diethylamide (LSD) and psilocybin between patients undergoing PAT and healthy volunteers. For the patients, it also investigated the relationship between antidepressant effects and six measures of acute drug effects. We compared data on acute psychedelic drug effects between 28 PAT patients with data from 28 healthy participants who participated in a randomized, double-blind crossover trial. All participants received varying doses of psilocybin and LSD. Subjective effects were assessed on an hourly basis during the acute drug effects, and the Mystical Experience Questionnaire (MEQ) was completed retrospectively. For patients, depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Ratings of overall drug effect and mystical experience were similar across groups. Compared with healthy controls, patients reported lower ratings of ego dissolution. Patients showed a significant decrease in MADRS scores, and the greatest predictor of antidepressant outcome was relaxation during the PAT session. We did not observe a relationship between mystical-type experiences and antidepressant effects. Most patients experienced mild adverse effects which resolved within 48 h. PAT reduced depressive symptoms in this heterogeneous patient group. Patients may experience more challenging psychedelic effects and reduced ego dissolution. Hourly assessment of drug effects may predict clinical outcomes better than retrospectively assessed mystical experiences, and the impact of relaxation during PAT should be investigated further.

Going Underground: Demographics, Services, and Best Practices Endorsed by Practitioners Providing Support for Naturalistic Psychedelic Use

ABSTRACT Psychedelic-assisted therapy (PAT) has shown preliminary efficacy for psychiatric and physical health conditions. Although some people report naturalistic psychedelic use with so-called “underground” practitioners, little is known about PAT that occurs outside of controlled clinical settings or perspectives of these practitioners. We conducted an anonymous online survey of individuals who reported providing psychedelic support services (e.g. trip sitting and/or preparatory/follow-up psychotherapy) in naturalistic settings. We investigated demographics, including education and licensing, details about services provided, and reported client outcomes. Among 107 participants, 40.2% held a full or in-progress license and 44.9% had not obtained a relevant graduate degree. Almost all participants reported pre-screening clients before treatment, offering preparation, integration, and trip-sitting services, and most employed a range of therapeutic modalities, centering primarily on non-directive approaches. Participants reported that clients most commonly consumed psilocybin, and treated numerous conditions, primarily aligning with indications targeted in psychedelic clinical research. Perceptions of clients’ symptom changes were largely positive, although a small proportion reported worsened personality disorder symptoms. Further research delineating client and practitioner perspectives of naturalistic PAT services is warranted, and such work may shed light on the benefits and risks specific to naturalistic PAT as well as inform best practices for practitioners.

Psychedelic research at a crossroads

There is an urgent need to develop better treatments for mental health conditions that affect one in every eight people in the world. To combat this concern, psychedelic drugs have been combined with psychotherapy and studied in clinical trials in the United States and Europe. Psychedelics are hallucinogenic drugs that alter brain activity and facilitate altered states of consciousness. The proposed benefits of psychedelic-assisted therapy (PAT) include relatively short treatment times and stronger effects compared to other treatments. Although results of trials using MDMA for trauma or psilocybin for depression are promising, PAT is controversial because many questions about its safety and effectiveness are unanswered. This is evident in the recent ruling by the US Food and Drug Administration against the approval of MDMA therapy for post-traumatic stress disorder and the retraction of several papers about MDMA trials owing to unethical conduct by study therapists and data integrity, among other concerns. This field is at a crossroads, and the research community must address several obstacles to transition from exploratory trials to established, evidence-based treatments while avoiding pitfalls that can hinder advancement.

Autonomic nervous system activity correlates with peak experiences induced by DMT and predicts increases in well-being.

Non-ordinary states of consciousness induced by psychedelics can be accompanied by so-called "peak experiences," characterized at the emotional level by their intensity and positive valence. These experiences are strong predictors of positive outcomes following psychedelic-assisted therapy, and it is therefore important to better understand their biology. Despite growing evidence that the autonomic nervous system (ANS) plays an important role in mediating emotional experiences, its involvement in the psychedelic experience is poorly understood. The aim of this study was to investigate to what extent changes in the relative influence of the sympathetic (SNS) and parasympathetic nervous systems (PNS) over cardiac activity may reflect the subjective experience induced by the short-acting psychedelic N,N-Dimethyltryptamine (DMT). We derived measures of SNS and PNS activity from the electrocardiograms of 17 participants (11 males, mean age = 33.8 years, SD = 8.3) while they received either DMT or placebo. Results show that the joint influence of SNS and PNS ("sympathovagal coactivation") over cardiac activity was positively related to participants' ratings of "Spiritual Experience" and "Insightfulness" during the DMT experience, while also being related to improved well-being scores 2 weeks after the session. In addition, we found that the state of balance between the two ANS branches ("sympathovagal balance") before DMT injection predicted scores of "Insightfulness" during the DMT experience, as well as subsequent sympathovagal coactivation. These findings demonstrate the involvement of the ANS in psychedelic-induced peak experiences and may pave the way to the development of biofeedback-based tools to enhance psychedelic therapy.

Lost in translation? Qualitative interviews with Australian psychedelic-assisted therapy trial clinicians.

Policy changes in Australia mean that psychedelic-assisted therapy (PAT) is now available to consumers outside of clinical trials. Yet, the regulatory frameworks guiding the practice of PAT are underdeveloped, and the evidence base for guiding clinical practice is diverse and emerging, resulting in anticipated challenges in translation to community practice. Mental health clinicians who have experience delivering PAT in clinical trials are likely to be at the forefront of community practice and training, and influential in discussions about implementation. Yet little is known of their perspectives, preferences, and practices associated with the implementation of PAT. Interviews with 11 clinicians working on clinical trials of PAT were thematically analysed. Four themes were identified, describing the therapeutic frames that interviewees used to understand PAT and shaped their views on its interface with the mental health system: (1) therapeutic eclecticism, (2) enhanced reflexivity for PAT providers, (3) legitimisation of extra-medical perspectives in mental health, and (4) what might be lost in translation? We argue that clinicians' perspectives on PAT are reflective of existing tensions between a medical model of mental health care and other psychosocial, relational models. Therapists' ideals for the delivery of PAT can be conceptualised as a sort of 'enhanced care' approach, but workforce development and economic constraints are likely to challenge the accessible and impactful translation of this vision.

Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases.

Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases.

A Cross-Sectional Survey Investigating Māori and Non-Māori Cancer Patients' Views on Psychedelic-Assisted Therapy in Aotearoa New Zealand.

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.

Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis.

A clear and comprehensive understanding of risks associated with psychedelic-assisted therapy is necessary as investigators extend its application to new populations and indications. To assess adverse events (AEs) associated with classic psychedelics, particularly serious AEs (SAEs) and nonserious AEs (NSAEs) requiring medical or psychiatric evaluation. The search for potentially eligible studies was conducted in the Scopus, MEDLINE, PsycINFO, and Web of Science databases from inception through February 8, 2024. Two independent reviewers screened articles of classic psychedelics (lysergic acid diethylamide [LSD], psilocybin, dimethyltryptamine [DMT], and 5-methoxy-N,N-dimethyltryptamine [5-MeO-DMT]) involving administration in clinical or research contexts. AE data were extracted and synthesized by 2 reviewers and were used for random-effects meta-analysis of AE frequency and heterogeneity. Risk of bias assessment focused on AE ascertainment (eg, systematic assessment and quality of follow-up). A hybrid approach was used for capture of all reported AEs following high-dose classic psychedelic exposure and confirmatory capture of AEs of special interest, including suicidality, psychotic disorder, manic symptoms, cardiovascular events, and hallucinogen persisting perception disorder. AEs were stratified by timescale and study population type. Forest plots of common AEs were generated, and the proportions of participants affected by SAEs or NSAEs requiring medical intervention were summarized descriptively. A total of 214 unique studies were included, of which 114 (53.3%) reported analyzable AE data for 3504 total participants. SAEs were reported for no healthy participants and for approximately 4% of participants with preexisting neuropsychiatric disorders; among these SAEs were worsening depression, suicidal behavior, psychosis, and convulsive episodes. NSAEs requiring medical intervention (eg, paranoia, headache) were similarly rare. In contemporary research settings, there were no reports of deaths by suicide, persistent psychotic disorders, or hallucinogen persisting perception disorders following administration of high-dose classic psychedelics. However, there was significant heterogeneity in the quality of AE monitoring and reporting. Of 68 analyzed studies published since 2005, only 16 (23.5%) described systematic approaches to AE assessment, and 20 studies (29.4%) reported all AEs, as opposed to only adverse drug reactions. Meta-analyses of prevalence for common AEs (eg, headache, anxiety, nausea, fatigue, and dizziness) yielded comparable results for psilocybin and LSD. In this systematic review and meta-analysis, classic psychedelics were generally well tolerated in clinical or research settings according to the existing literature, although SAEs did occur. These results provide estimates of common AE frequencies and indicate that certain catastrophic events reported in recreational or nonclinical contexts have yet to be reported in contemporary trial participants. Careful, ongoing, and improved pharmacovigilance is required to understand the risk and benefit profiles of these substances and to communicate such risks to prospective study participants and the public.

Examining the influence of team-based learning on medical students' comprehension and attitudes regarding psychedelic therapies.

This study evaluates the impact of a two-hour team-based learning (TBL) curriculum on medical students' knowledge, comprehension, ethical understanding, and attitudes towards psychedelic therapies. Sixty-three pre-surveys and fifty post-surveys assessed students' perceived knowledge and attitudes using Likert scales. Forty-eight matched pre/post-knowledge tests with multiple-choice questions quantified changes in comprehension. The TBL approach featured independent learning, team readiness assessments, and application exercises. Post-curriculum, students demonstrated significantly improved test scores (mean 41.4% increase, p < 0.0001) and more positive attitudes across 16 of 18 items (p ≤ 0.0495). Overall attitude scores increased 23% (p < 0.0001). Qualitative feedback reflected enhanced comfort discussing psychedelics clinically. While some students expressed support for psychedelic-assisted therapy, others cited reservations. This innovative curriculum bridged an important education gap given the increasing relevance of psychedelic medicine. Findings suggest TBL enhances medical student preparedness in this emerging field. Continued curricular development is warranted to ensure proper psychedelic education aligns with patient needs and legislative policies. As psychedelic research progresses, maintaining instructional excellence is crucial for future healthcare professionals.

Fire Kasina advanced meditation produces experiences comparable to psychedelic and near-death experiences: A pilot study

Psychedelic-assisted therapy studies suggest that the induction of “mystical experiences” combined with psycho-therapy is a possible intervention for psychiatric illness. Advanced meditation may induce powerful experiences comparable to psychedelics. We investigated effects of an intensive meditation practice called Fire Kasina. Six individuals completed a retreat, and participated in an interview in which they described their experiences. They also completed the Revised Mystical Experience Questionnaire (MEQ), Hood Mystical Experience Scale (HME), and Cole's Spiritual Transformation Scale. Mean MEQ scores were 85 %, similar to prior observations of high-dose psilocybin and were stronger than moderate-dose psilocybin (t(5) = 4.41, p = 0.007, d = 1.80; W(5) = 21, p = 0.031). Mean HME scores were 93 %, exceeding levels reported for NDEs (mean 74 %) and high-dose psilocybin (mean 77 %). In qualitative analysis, experiences were described as the most intense of the individual's life, while subsequent transformational effects included substantial shifts in worldview.

Validation of the Swiss Psychedelic Side Effects Inventory: Standardized assessment of adverse effects in studies of psychedelics and MDMA

IntroductionStudies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and sensitivity to context. A systematic questionnaire describing important characteristics of side effects of psychedelics and MDMA would greatly improve on previous methods. We aimed to create a standardized tool for recording clinically relevant side effects of psychedelics and MDMA, including their severity, duration, impact, and treatment-relatedness. MethodsWe constructed the Swiss Psychedelic Side Effects Inventory (SPSI) based on insights from previous research. It was pilot tested in 145 participants from three studies. Structured feedback from an expert panel was used to improve validity and feasibility. ResultsThe final SPSI contains 32 side effects and standardized follow-up questions about their severity, impact, treatment-relatedness, and duration. It is compatible with any study design and can be administered as an interview or self-report at any timepoint after treatment with psychedelics or MDMA. LimitationsThe SPSI omits relatively unimportant side effects for brevity's sake, though space for additional symptoms is given. Future studies are needed to confirm its validity in different contexts. ConclusionsThe SPSI is available in English and German for collecting systematic data on side effects from psychedelics and MDMA. This information is vital for improving clinical decisions, informed consent, and patient safety.

Comforting delusions? How to evaluate the plausibility of mystical-type insights in psychedelic experiences

ABSTRACT Psychedelics can facilitate mystical-type insights and beliefs, such as the belief that the fundamental nature of reality is loving consciousness. These belief changes could underlie the positive effects of psychedelics on wellbeing. However, mystical-type beliefs have been criticized of being delusional, as they contradict naturalism. Here I argue that naturalism is one metaphysical position among several competing ones. There is no definite way of choosing one metaphysical theory over others, as there are several metaphysical positions that are internally consistent and compatible with scientific knowledge. This calls for metaphysical agnosticism, which entails that psychedelic-facilitated metaphysical beliefs cannot be considered as delusional simply if they contradict naturalism. However, the challenge is to distinguish between beliefs that are strictly metaphysical and other mystical-type beliefs, which can include, for example, paranormal beliefs. Metaphysical agnosticism does not apply to the latter and they can be considered as problematic. I apply metaphysical agnosticism to evaluate mystical-type belief changes associated with the use of psychedelics, as indicated by empirical research. I consider the possibility that mystical-type beliefs are ineffable and non-conceptual, which entails that we should not take conceptualizations of them too seriously. I conclude by discussing the implications of metaphysical agnosticism for psychedelic-assisted therapy.

A framework for assessment of adverse events occurring in psychedelic-assisted therapies.

Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed. A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research. Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement). This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.