Randomized controlled trials (RCTs) are considered the gold standard for demonstrating the efficacy of a treatment or intervention; however, the RCT study design alone is insufficient to prevent all forms of bias. In this paper, we review conflicts of interest and other biases that pose challenges to the methodological rigor of psychedelic RCTs, and explore recommended bias mitigation measures....
Research has demonstrated both risks and benefits to using psychedelics as a therapeutic intervention for a variety of mental health conditions. In recent years, the public discourse around psychedelic treatments has been largely positive and focused on benefits more than risks. We believe the field would benefit from more balanced attention to the risks as well as benefits of psychedelics...
Objective: This article outlines recommendations from 30 psychedelic researchers on how to create a better psychedelic safety net. Methods: A survey of 30 psychedelic researchers asked them to identify key critical research gaps around psychedelic harm and safety. Results: The critical research gaps identified by the authors included defining the main types of psychedelic harm, the predictors...
Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for...
Wellcome Open ResearchJanuary 13, 2025Samuel Streicher, Christopher Register, Xiu Lim et al.2 citations
Background: Moral bioenhancement typically refers to the deliberate use of drugs or biotechnologies, potentially alongside other practices, to attempt to improve oneself morally. In addition to general concerns regarding moral self-bioenhancement, the possibility of using psychedelic substances for such purposes raises distinct ethical questions. As a first step in analysing these questions, we...
When used clinically, psychedelics may appear unusual or even unique when compared to more familiar or long-standing medical interventions, prompting some to suggest that the ethical issues raised may likewise be exceptional. If that is correct, then perhaps psychedelics should be treated differently from other medical substances: for example, by being subjected to different ethical or...
Cannabis Use Disorder (CUD) is an increasingly prevalent disorder affecting millions of Americans each year. Psychedelic compounds have recently been investigated for their therapeutic potential in treating substance use disorders, yet no prior work has examined the relationship between naturalistic use of specific psychedelic compounds and rates of disordered cannabis use. Using a nationally...
In this review, we discuss psychedelics' acute subjective and persisting therapeutic effects, outline the science of positive emotions, and highlight the value in considering distinct positive emotions in psychedelic science. Psychedelics produce a wide variety of acute subjective effects (i.e. the 'trip'), including positive emotions and affective states such as awe and joy. However, despite a...
Abstract The proportion of people who change their metaphysical beliefs after psychedelic experiences is not yet known with specificity. However, it appears that belief changes can occur in some cases, and evidence more precisely estimating the prevalence and magnitude of such belief changes is accruing. The evidence for metaphysical belief changes is reviewed and the potential psychological...
Importance A clear and comprehensive understanding of risks associated with psychedelic-assisted therapy is necessary as investigators extend its application to new populations and indications. Objective To assess adverse events (AEs) associated with classic psychedelics, particularly serious AEs (SAEs) and nonserious AEs (NSAEs) requiring medical or psychiatric evaluation. Data Sources The...
Despite widespread engagement in contemplative religious practices, comparatively little research has been conducted on their potential effects on well-being. Furthermore, few studies have focused on how an explicitly religious framing may impact the outcomes of such practices. In this online randomized controlled trial (N = 702), we tested the well-being effects of a contemplative prayer...
A number of organizations have developed or are developing psychedelic integration groups, held in person or online. In parallel, there have been calls to make enhanced integration available in the community after clinical trials. Here, we explore a potential reason why individuals may seek out these groups: namely, the feelings of disconnection and loneliness that may arise after the...
As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians,...
Prolonged Grief Disorder (PGD) is distinct from yet related to non-pathologic grief, depression, addiction, and Post-Traumatic Stress Disorder (PTSD) with a prevalence of up to 10% in bereaved populations. Hallmarks of PGD include functional impairment a year or more post-bereavement and intense yearning for the deceased. Current treatments for PGD are typically psychological rather than...
Recent studies suggest psychedelic use may be associated with changes in a variety of beliefs or belief-like states, including increased 1) mind perception, 2) non-naturalistic beliefs, and 3) Atheist-Believer status (e.g. believer, agnostic, or nonbeliever). We conducted a prospective longitudinal study among participants (N = 657) who planned to have a psilocybin experience outside a...
The first Hopkins-Oxford Psychedelic Ethics (HOPE) workshop convened to discuss ethical matters relating to psychedelics in August 2023 at the University of Oxford.The organizers (BDE, DBY, EJ) aim...
Rationale: Psychedelic research re-emerged from a period of suppression into the so-called psychedelic renaissance. In parallel, most media reporting has shifted from the overstatement of the risks of psychedelics to overly positive hype. As the empirical evidence is more equivocal than frequently portrayed, the conclusions about the effectiveness of psychedelics should be considered...
The psychedelic psilocybin has shown promise both as treatment for psychiatric conditions and as a means of improving well-being in healthy individuals. In some jurisdictions (e.g., Oregon, USA), psilocybin use for both purposes is or will soon be allowed and yet, public attitudes toward this shift are understudied. We asked a nationally representative sample of 795 US Americans to evaluate the...
Substance use disorders (SUDs) have an enormous impact on public health. With classic psychedelic-assisted therapies showing initial promise in treating multiple SUDs, it is possible that these treatments will become legally available options for patients with SUDs in the future. This article highlights how classic psychedelic-assisted therapies might be integrated into current clinical...
ABSTRACT: Psychedelics, including psilocybin, and other consciousness-altering compounds such as 3,4-methylenedioxymethamphetamine (MDMA), currently are being scientifically investigated for their potential therapeutic uses, with a primary focus on measurable outcomes: for example, alleviation of symptoms or increases in self-reported well-being. Accordingly, much recent discussion about the...
Several recent studies have investigated psilocybin as a novel therapeutic compound for the treatment of existential distress in patients with cancer, demonstrating persistent, positive effects on mood. This editorial discusses two articles in the current issue of Cancer that report findings of a group‐based psilocybin‐assisted intervention for treatment of depression in patients diagnosed with...
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ABSTRACT Reports of psychedelic experiences may contain similarities and differences across cultural contexts, but most current characterizations and quantifications of psychedelic experiences come from Western medical and naturalistic settings. In this article, we begin with a brief history of the diversity of psychedelic use in non-Western settings. We then compare and contrast accounts of...
Psychedelics such as psilocybin reliably produce significantly altered states of consciousness with a variety of subjectively experienced effects. These include certain changes to perception, cognition, and affect,1 which we refer to here as the acute subjective effects of psychedelics. In recent years, psychedelics such as psilocybin have also shown considerable promise as therapeutic agents...
Recent studies suggest psychedelic use may be associated with changes in a variety of beliefs or belief-like states, including increased 1) mind perception, 2) non-naturalistic beliefs, and 3) Atheist-Believer status (e.g., believer, agnostic, or non-believer). We conducted a prospective longitudinal study among participants (N = 657) who planned to have a psychedelic experience. We asked...