Psychedelics represent a potential breakthrough for treatment-resistant depression; however, the prolonged in-clinic monitoring required for compounds such as psilocybin and lysergic acid diethylamide is a logistical hurdle to widespread use. Intranasal mebufotenin (5-methoxy-N,N-dimethyltryptamine), a 5-hydroxytryptamine 1A (5-HT1A) and 5-HT2A agonist associated with brief psychedelic...
BackgroundWhile psychedelic treatments for difficult-to-treat mental health conditions are advancing, participant perspectives remain under-explored. This study examined former participants’ experiences across recruitment, preparation, dosing, integration and study ending, and generated recommendations for future trials and treatment delivery.MethodsThis qualitative descriptive study, informed...
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...
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.
Emerging evidence supports 5-MeO-DMT as a promising, ultra-short-acting psychedelic for treatment-resistant depression and other psychiatric conditions, warranting larger RCTs.
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,...
5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a naturally occurring psychedelic tryptamine. Plants containing 5-MeO-DMT have been used throughout history, and in recent years both synthetic and toad-derived 5-MeO-DMT use is being increasingly reported in naturalistic settings as well as clinical research. However, its subjective effects are not well characterised, and no qualitative research...
Matt Butler has nothing to declare. Sanjay Cheema: Received a research fellowship sponsored by Abbott. Giorgio Lambru: Co-chair of the Medical Advisory Board of the Trigeminal neuralgia Association (TNA) UK; received personal fees from Abbvie, Teva, Novartis, Eli Lilly, Lundbeck; participated in clinical trials as principal investigator for Novartis, Eli Lilly, Teva, Nevro. Manjit Matharu:...
Abstract Background Short‐lasting unilateral neuralgiform headache attacks (SUNHA) are trigeminal autonomic cephalalgias that feature intense and recurrent paroxysms of pain and autonomic symptoms. Many patients are left with debilitating symptoms despite best‐available treatment. Psychedelics, such as the serotonin 2A partial agonist psilocybin, have shown promise in related disorders such as...
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BPL-003, a novel intranasal benzoate salt formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), in healthy participants. In all, 44 psychedelic-naïve participants enrolled in the double-blind, placebo-controlled single ascending dose study (1-12 mg BPL-003). Concentrations of 5-MeO-DMT and its...
Classic psychedelics: safety, side effects and medication interactions Given the growing scientific and social interest in the use of classic psychedelics for psychiatric disorders, physicians are increasingly confronted with patients resorting to these drugs. To this date, treatment with classic psychedelics within a medical framework is non-existent. Patients could seek such a treatment...
Psilocybin is being studied for use in treatment-resistant depression. In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the...
Objective: Functional neurological disorder (FND) causes a high burden of disability and distress. Although it is a common disorder, there is a pressing need for improved access to evidence-based treatments. With difficulties in finding effective treatment, some people with FND may seek alternative means of symptom relief, such as legal and illicit psychoactive substances, although the...
Approximately 1.25 million people in the UK suffer from an eating disorder, yet the treatment options show limited efficacy, warranting the need for novel approaches. This study aimed to investigate the perspectives of people with eating disorders on the use of complementary therapies and psychedelic research and treatment. Two hundred participants with eating disorders took part in this web...
Aims Functional neurological disorder (FND), formerly known as conversion disorder, causes a high burden of disability and distress, and is amongst the most commonly encountered conditions in neurology clinics and neuropsychiatry services, yet the therapeutic evidence base is limited. Research into psychedelics such as psilocybin and lysergic acid diethylamide (LSD) is currently being...
Functional neurological disorder (FND), formerly known as conversion disorder, causes a high burden of disability and distress, and is amongst the most commonly encountered conditions in neurology clinics and neuropsychiatric services, yet the therapeutic evidence base is somewhat limited. There has been recent interest in the therapeutic potential of psychedelics such as psilocybin and...
Background: 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), also officially known as Mebufotenin, is a naturally occurring serotonergic psychedelic alkaloid found in the venom of the Sonoran Desert toad (Incilius alvarius) and various plant species. Areas of Uncertainty: Trace levels of 5-MeO-DMT may be produced endogenously in humans, but its physiological role remains unclear. Safety profiles...