Australia's reclassification of psilocybin as a Schedule 8 substance for treatment-resistant depression represents a significant shift in psychiatric policy. While this regulatory change positions Australia as a global leader in psychedelic medicine, its implementation has revealed substantial challenges. This article critically examines the regulatory, ethi...
This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psiloc...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
OBJECTIVES: To assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy (PAT) for demoralisation in terminally ill patients receiving home hospice care. METHODS: In this open-label pilot trial, 4607 home hospice patients at a large community hospice were screened over 22 months; 66 were approached, 15 enrolled and 10 received ps...
This retrospective observational study examines the effects of psychedelic-assisted psychotherapy (PAP) with lysergic acid diethylamide (LSD) or psilocybin in patients with treatment-resistant depressive, anxiety, or addictive disorders. Data will be analyzed from patients treated at the University Hospitals of Geneva between June 2020 and April 2025 who obt...
Based on promising preliminary results from clinical trials, it seems likely that psychedelic substances (classic serotonergic psychedelics, such as psilocybin, and entactogens, such as MDMA) will be introduced into psychiatry as psychedelic-assisted therapy. This also raises a range of ethical questions that urgently need to be addressed before widespread r...
The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive...
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...
Classic psychedelics are increasingly studied as potential treatments for different psychiatric disorders. Current research protocols often require patients to discontinue antidepressants (ADs) for at least 2 weeks before psychedelic administration to decrease the risk of serotonin syndrome and limit their effect on efficacy and the acute subjective effects ...
Psychedelic substances have experienced a resurgence of clinical interest in recent years, particularly for their promising effects in the treatment of psychiatric disorders such as depression and anxiety. While evidence regarding their role in chronic pain management remains limited, emerging studies suggest potential therapeutic benefits. This case report ...
Abstract Background Psychedelic-assisted therapy (PAT) is gaining attention as a potential treatment for cancer-related psychosocial symptoms. While growing evidence highlights its promise, little is known about how different stakeholder groups perceive its use in oncology and palliative care. Objectives This study aimed to assess stakeholder-specific perspe...
Psychedelics are often queried as a potential therapeutic option in a multitude of conditions, including pain and mental health disorders, with a growing body of patient reports and scientific publications describing potential benefit. This article reviews recent research on psychedelic compounds for treatment of headache disorders. Observational data, case ...
BACKGROUND AND AIMS: Psilocybin has emerged as a potential treatment for alcohol use disorder (AUD), but early efficacy data are inconsistent. Depression following alcohol detoxification significantly increases the risk of relapse. This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of psilocybin-assisted psychotherapy...
Background: Alcohol Use Disorder (AUD) is a chronic pathological condition with significant burdens throughout the world. Despite the effectiveness of the current pharmacological treatments, the ongoing issues with AUD and the high relapse rates necessitate the exploration of innovative therapies, including the use of psychedelic drugs, which have shown prom...
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, unde...
This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Sc...
Psilocybin-assisted psychotherapy represents a promising addition to palliative care interventions, potentially improving quality of life by addressing existential distress. Despite its safety and effectiveness, this therapy remains limited in Canada, underscoring the need for improved access to ease suffering from life-threatening illnesses. However, import...
Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation...
Clinical trials using full doses of psychedelics have provided preliminary evidence supporting their safety and efficacy in treating a variety of physical and psychological conditions. Anecdotal reports indicate that even very small amounts of these substances may provide therapeutic benefits, though robust clinical studies are still needed. This chapter rev...
