This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder. This protocol is for a University of Toronto - sponsored, randomized, placebo-controlled crossover phase 2 study of the safety and efficacy of low doses of psilocybin in subjects with depressive symptoms who meet ...
Introduction: Major depressive disorder (MDD) affects over 21 million adults in the U.S (NIMH, 2023) and remains a significant public health challenge. Despite the effectiveness of traditional medications, 30% of patients remains resistant. Little is known about the beliefs individuals hold regarding novel treatments, such as psilocybin and the motivations b...
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet The proposed randomized, double-blind, active control study will compare a single exper...
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid use disorder (OUD). The participants will have previously undergone buprenorphine induction before. Effects of adjunctive psilocy...
This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together w...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a common and disabling condition. A large proportion of patients fail to respond to first-line treatment with serotonin reuptake inhibitors either selective serotonin reuptake inhibitors (SSRIs) or clomipramine. Preliminary evidence suggests psilocybin, a serotonin receptor agonist, might be efficacious. We ...
BACKGROUND: Psilocybin-assisted psychotherapy (PAP) is a promising treatment for various psychiatric disorders. However, the exact biological and psychological mechanisms of action of PAP remain to be determined. Examining predictors of PAP outcomes may help identify necessary processes for positive treatment outcomes. Mystical experiences are considered a k...
Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date h...
Psychedelic-assisted therapies have demonstrated promising results in treating mental disorders, with results suggesting that the subjective intensity and quality of psychedelic experiences plays a significant role in mediating therapeutic effects. However, the strength of this association across diagnoses and treatment settings remains underexplored. We sea...
This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin. Study Design Interventional, Single arm, open label 1\. Hypotheses: 1. It is feas...
This retrospective case study features a woman in her mid-50s who spent her childhood in a religious community plagued by sexual abuse of children. She was abused by her father for more than a decade. The church and her mother ignored her reports about it. In her early twenties, she enrolled herself in the Erhard Seminars Training program that destabilized h...
This retrospective case study features a woman in her mid-50s who spent her childhood in a religious community plagued by sexual abuse of children. She was abused by her father for more than a decade. The church and her mother ignored her reports about it. In her early twenties, she enrolled herself in the Erhard Seminars Training program that destabilized h...
ObjectivesMood disorders and existential distress impact those with cancer or a serious illness at higher rates than the general population. There have been limited pharmacological advances in recent years, and available psychological interventions vary in degree of impact and durability as a treatment modality in this population. A recent renaissance in psy...
The stressors that frontline healthcare workers experienced during the COVID-19 pandemic led to widespread burnout, depression, and post-traumatic stress disorder (PTSD). Based on research showing that psychedelic-assisted therapy led to improvement in symptoms of depression in various populations, investigators conducted a randomized clinical trial to evalu...
PurposeTo evaluate the current level of evidence for the use of psychedelics for the management of cancer pain and associated psychological distress.ContentPain is a common symptom of cancer and treatment. However, there are high rates of undertreatment of cancer pain due to the complex underlying biology of the condition, and potentially due to a decrease i...
ObjectiveThe authors critically examine the evidence base for psilocybin administered with psychological support/therapy (PST) in the treatment of psychiatric disorders and offer practical recommendations to guide future research endeavors.MethodsPubMed was searched for English-language articles from January 1998 to November 2023, using the search term "psil...
Psilocybin use has been increasingly popular in the United States, and its use as a novel therapeutic treatment for psychiatric conditions has led to greater public acceptance as a recreational substance. Consequently, clinicians are faced with managing complications and adverse effects associated with psilocybin use. We present three cases seen in a dual di...
This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the f...
Background SAPAP3-knockout (KO) mice develop excessive self-grooming behavior at 4-6 months of age, serving as a model for obsessive-compulsive disorder (OCD). Given that anxiety often precedes OCD diagnosis in humans, this study investigated whether juvenile SAPAP3-KO mice exhibit anxiety-like behaviors before developing the self-grooming phenotype, and whe...
Background: Psilocybin therapy (PT) produces rapid and persistent antidepressant effects in major depressive disorder (MDD). However, the long-term effects of PT have never been compared with gold-standard treatments for MDD such as pharmacotherapy or psychotherapy alone or in combination. Methods: This is a 6-month follow-up study of a phase 2, double-blind...
