Naturally derived psilocybin is widely used, yet its therapeutic potential, pharmacological distinctiveness and regulatory feasibility remain understudied. This review evaluates the potential of naturally derived psilocybin using a six-criterion framework to evaluate: (1) therapeutic benefit, (2) safety and tolerability, (3) pharmacological uniqueness vs. sy...
Psilocybin-producing mushrooms exhibit considerable biochemical diversity, yet the extent of variability among strains within a single species under standardized conditions remains insufficiently characterized. In this study, we quantified psilocybin, psilocin, baeocystin, norbaeocystin, aeruginascin, and norpsilocin in the fruiting bodies of 14 distinct str...
Microdosing and related low-dose psychoactive practices have become increasingly visible in discussions of mental health, cognition, creativity, emotional regulation, pain, sleep, spirituality, and psychological flexibility. However, the term microdosing is often used as if it referred to a single pharmacological phenomenon. More precisely, it describes a lo...
Background and objective: Anxiety disorders are among the most prevalent psychiatric disorders worldwide and affect all age groups. Current pharmacological treatments, such as selective serotonergic reuptake inhibitors (SSRI’s) and benzodiazepines, have limitations in terms of adverse effects and efficacy, which highlights the need for alternative therapies....
Interest in psychedelic-assisted therapy (PAT) is surging across research and medical communities, prompting the discussion of policy shifts that reflect growing openness to implementing psychedelics in clinical practice. State-level psychedelic reform in the United States has accelerated since 2019, with legalization projected to reach most states within th...
Psilocybin-assisted therapy (PAT) is an emerging intervention for depression. Though several clinical trials report promising results for PAT in treating depression, there remains a need for consensus on optimal methodologies and standardization of PAT protocols. The objective of this review was to assess the efficacy of PAT in treating depressive symptoms a...
Abstract Natural variation in psilocybin content across mushroom samples presents a significant challenge to consistent dosing in both research and retreat settings. In this observational report, we describe a pragmatic approach for quantifying psilocybin content in naturally sourced material to ensure more standardized dosing across participants. Eleven ind...
Background/Objectives: This study examines the development of clinical trials investigating psilocybin for the treatment of psychopathologies, with a comparative focus on the United States (US) and the European Union (EU). The objective is to identify regional differences in trial progression, research infrastructure, and regulatory frameworks. Methods: A mi...
Accumulating evidence suggests that psilocybin can produce rapid and sustained clinical benefits when administered in conjunction with psychological support. Though non-pharmacological procedures are considered integral, the field lacks therapeutic guidelines and little is known about current practices. This systematic review sought to provide a comprehensiv...
The growing body of evidence supporting the therapeutic efficacy of psychoactive substances, like psilocybin, has driven significant interest in recent decades due to their low toxicity and potential applications in treating various mental health disorders. However, producing pharmaceutical-grade psilocybin remains challenging, with three primary approaches:...
Introduction Since the last edition of the Black Book, several innovative agents have been approved or are poised to be approved in the coming year. These include novel antidepressants, the first muscarine agonist for the treatment of schizophrenia, the first psychedelic which may be approved for the treatment of PTSD (Post Traumatic Stress Disorder), and th...
BackgroundPsychedelic-assisted therapy has gained significant attention in recent years. However, there is a lack of empirical clarity on the role of psychosocial interventions (PIs) in clinical trials of psychedelic treatment due in part to deficiencies in reporting practices found in the existing literature. These PI include non-drug support or interventio...
Background: Psychedelic-assisted therapy has gained significant attention in recent years. However, there is a lack of empirical clarity on the role of psychosocial interventions (PI) in clinical trials of psychedelic treatment due in part to deficiencies in reporting practices found in the existing literature. These PI include non-drug support or interventi...
Background: Psychedelic-assisted therapy has gained significant attention in recent years. However, there is a lack of empirical clarity on the role of psychosocial interventions (PI) in clinical trials of psychedelic treatment due in part to deficiencies in reporting practices found in the existing literature. These PI include non-drug support or interventi...
With the Food and Drug Administration designation in 2017 of 3,4-methylenedioxymethamphetamine (MDMA) as a breakthrough therapy in post-traumatic stress disorder and psilocybin in treatment-resistant depression, psychedelic drugs have continued to garner the attention of researchers and clinicians for their promise of unmatched, rapid improvement in a multit...
Back to table of contents Previous article Next article Clinical & ResearchFull AccessPsychedelic Renaissance: Clinical Health Justice, Patient Safety, and Equity Need to Be Put FirstJacques Ambrose, M.D., M.P.H., Jeffrey Zabinski, M.D., M.S.W.Jacques AmbroseSearch for more papers by this author, M.D., M.P.H., Jeffrey ZabinskiSearch for more papers by this a...
BackgroundPsilocybin is a serotonin type 2A (5-HT2A) receptor agonist and naturally occurring psychedelic. 5-HT2A receptor density is known to be associated with body mass index (BMI), however, the impact of this on psilocybin therapy has not been explored. While body weight-adjusted dosing is widely used, this imposes a practical and financial strain on the...
Purpose/backgroundThere has been resurgence of interest in the therapeutic use of serotonergic ("classic") psychedelics in major depressive disorder (MDD) and end-of-life distress. This commentary offers a critical appraisal of current evidence for antidepressant effects of classic psychedelics from contemporary clinical trials and highlights pitfalls that s...
Psychedelic or ecodelic medicines (e.g., psilocybin, ayahuasca, iboga) for the care and treatment of addiction, post-traumatic stress disorder, cancer, cluster headaches, anxiety, and depression have surged to the forefront of discussions about mental health in the US, leading to the emergence of well-capitalized biotech companies offering multimillion-dolla...
