BACKGROUND: Psychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This study examined the feasibility and safety of administering movement tasks following low-to-moderate doses of psilocybin in healthy volunteers....
Psilocybin-assisted therapy may be a promising new treatment for treatment-resistant depression. We examined the feasibility of administering a single 25-mg dose of psilocybin or placebo with psychological support in a randomized controlled trial design with 6 weeks of follow-up. A two-arm, double-blind, randomized, placebo-controlled feasibility trial was conducted at one National Health...
BACKGROUND AND AIMS: This study qualitatively explored psychological change processes as described by participants and therapists within a phase 2a clinical trial evaluating the safety, tolerability, and preliminary efficacy of a single dose of intranasal 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT; BPL-003) administered alongside psychological support and manualised cognitive behavioural...
Abstract Research examining psychological outcomes following psychedelic use has grown substantially, yet the role of childhood trauma in shaping these responses remains insufficiently understood. This scoping review mapped the literature examining childhood trauma in relation to post-psychedelic psychological outcomes. Thirty-four sources met inclusion criteria and investigated substances...
Setting up a psychedelic study can be a long, arduous, and Kafkaesque process. Researchers are faced with a host of challenges in this rapidly evolving field, necessitating a range of considerations that remain largely unstandardised. Many of the complexities inherent to psychedelic research also challenge existing assumptions around, for example, approaches to psychiatric prescribing, the...
Recent clinical trials have suggested the safety and efficacy of psychedelic therapy for treatment-resistant depression, posttraumatic stress disorder, addiction, and end-of-life distress. While neurobiological mechanisms such as 5-HT2A receptor activation, increased neural entropy, and default mode network modulation have been well-characterized, significantly less attention has been given to...
Despite renewed investigations into classical psychedelic compounds, their pharmacokinetic profiles remain incompletely understood. This systematic review collated data from healthy adult volunteers on the pharmacokinetic properties of lysergic acid diethylamide (LSD), psilocybin, dimethyltryptamine (DMT), mescaline, and 5-methoxy-N,N-dimethyltryptamine (5-MEO-DMT). We identified 32 eligible...
Hallucinogen persisting perception disorder (HPPD) is characterised by episodes of altered perception linked to past psychoactive drug use, accompanied by distress and functional impairment. To date, clinical characterisation has been limited in scale. Using TriNetX, a global federated health research network of electronic health records, we conducted a retrospective cohort study comparing...
Results confirmed the safety profile of BPL-003 in a TRD population. A rapid and sustained reduction in MADRS score was observed over 12 weeks, suggesting BPL-003 could be beneficial in TRD, warranting investigation in larger controlled trials.
Background: Changes in well-being, personality, and personal values have been documented post-psilocybin; however, evidence from placebo-controlled trials is limited. Aims: To examine the effects of psilocybin versus placebo on psychiatric symptoms, personality, and personal values in healthy participants. Potential mediators were also explored. Methods: This secondary analysis used data from a...
2026Canyon Akromis, Lorraine Li, Kwon Mok Ko et al.
preprint
This project is a secondary analysis of data from Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) study, a phase II, randomised, placebo-controlled clinical trial where participants with treatment resistant depression received either 25 mg of psilocybin or a placebo alongside psychotherapy. This research seeks to determine whether the therapeutic alliance, measured by the...
Abstract Background and Aims Psychedelic drugs may help treat alcohol use disorder (AUD). This study evaluated BPL‐003, a novel intranasal powder formulation of 5‐methoxy‐N,N‐dimethyltryptamine (5‐MeO‐DMT) benzoate salt, in people with moderate–severe AUD enrolled in a standard of care, 10‐week programme of relapse‐prevention oriented Cognitive Behavioural Therapy (CBT). Design Open‐label,...
Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to explore participant experiences of psilocybin...
Abstract Background: Motor functional neurological disorder (FND) is a common illness associated with significant functional impairment. There are no effective pharmacotherapies, and despite the early promise of physiotherapy studies, many suffer disabling symptoms in the long term. There is a theoretical rationale for combining psychedelics with physiotherapy; however, the potential benefit of...
As recreational psychedelics increase, it is important to understand possible consequences, like identity disturbance, and how they may be mitigated with harm-reduction techniques. For example, people may spend time in nature or engage in journaling after recreational use to “self-integrate.” The present study aimed to investigate differences in measures of well-being and identity disturbance...
Psychedelics are undergoing a clinical research renaissance, with compounds such as psilocybin advancing to Phase 3 trials for treatment-resistant depression and receiving fast-track or breakthrough designations from regulatory agencies. Despite this progress, the field lacks standardized terminology to guide clinical development, dosing, safety monitoring, and regulatory classification. Here,...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition for which there are few efficacious treatments. Psilocybin is being studied for use in treatment-resistant depression but has not yet been investigated in PTSD. Aims: The trial’s primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participants with PTSD. Methods: This was a...
Background: Current trauma treatment options often fail to meet patients' needs. Despite the availability of established interventions, many trauma treatments fail to adequately meet patients' needs. In parallel, there has been renewed scientific and public interest in the therapeutic potential of psychedelics and related compounds, accompanied by increasing unsupervised use. This underscores...
Ketamine has emerged as a putative rapid-acting treatment option for psychiatric disorders, particularly treatment-resistant depression. Chronic recreational ketamine use is associated with ketamine-induced urological toxicity, raising concerns over the safety of repeated ketamine treatments. This systematic review aimed to synthesise urological findings from clinical trials and observational...
Post-traumatic stress disorder (PTSD) and associated trauma and stressor-related disorders are common and debilitating, presenting significant treatment challenges due to their complex interplay of biological, cognitive, affective, somatic and social factors. Current treatments, while advancing and effective, yield limited efficacy for many individuals, underscoring the need for novel...
Psychedelic substances exhibit complex interactions with the 'set and setting' of use, that is, the mental state of the user and the environment in which a psychedelic experience takes place. Despite these contextual variables' known importance, psychedelic research has lacked methodological rigor in reporting extra-pharmacological factors. This study aimed to generate consensus-based...
Background Functional neurological disorder (FND) is a common cause of neurological symptoms including seizures and movement disorders. It can be debilitating, is associated with high health and social care costs, and can have a poor prognosis. Functional magnetic resonance imaging (fMRI) has suggested FND is a multi-network disorder. Converging evidence suggests that other mechanisms including...
Setting up a psychedelic study can be a long, arduous, and kafkaesque process. This rapidly-developing field poses several unique challenges for researchers, necessitating a range of considerations that have not yet been standardised. Many of the complexities inherent to psychedelic research also challenge existing assumptions around, for example, approaches to psychiatric prescribing, the...
Abstract Background and aims This is the first systematic review of the extant literature on all major psychedelic‐assisted treatment for alcohol use disorder (AUD), tobacco use disorder (TUD) and other substance use disorders (SUD). We aimed to summarise the evidence for efficacy of psychedelic‐assisted treatment for AUD, TUD, and SUD; to evaluate its quality; and to offer recommendations for...
Background: Psychedelics such as psilocybin, lysergic acid diethylamide, and 3,4-methylenedioxymethamphetamine are increasingly recognized for their potential therapeutic benefits in treating complex and chronic mental health conditions. Growing public interest in psychedelics may drive increased consumption outside of medically supervised clinical trials. Correspondingly, legality issues and...