This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use. This pilot study will be a double blind, randomized, active-comparator controlled trial with two study arms. Subjects randomized to Arm 1 (n=10) will receive individual psych...
Background: Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental hea...
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...
BackgroundOver the past ten years, several psychedelic compounds, including tryptamines like lysergic acid diethylamide/LSD, psilocybin, ayahuasca, and dimethyltryptamine/DMT, have been tested in clinical trials for a range of psychiatric conditions, such as anxiety and depression. While these compounds are relatively available for treatment, ketamine and it...
BACKGROUND: Individuals with advanced cancer often experience high levels of distress for which there are few standardized treatment approaches. Our multidisciplinary team has combined existing evidence-based approaches into Psilocybin-assisted Existential, Attachment, and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted p...
The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive...
BACKGROUND & AIMS: There are few effective treatments for methamphetamine use disorder, despite increasing global demand. Here, we assessed the safety and feasibility of outpatient psilocybin-assisted psychotherapy for methamphetamine use disorder. DESIGN: Single arm, open label pilot study. SETTING: Outpatient public stimulant treatment program at St. Vince...
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes...
BackgroundMajor depressive disorder (MDD) is a significant public health concern, and current treatments often have limitations in effectiveness and adherence. Psilocybin, a psychedelic compound found in certain mushrooms, is being explored as a potential treatment for depression. It primarily acts through the serotonin 5-HT2A receptor but interacts with 5-H...
Background: Depressive disorders are a major global health challenge, with many individuals unresponsive to existing treatments. Novel psychedelic therapies show promise but require further research. Objectives: This study aimed to evaluate the feasibility, safety and effectiveness of psilocybin with psychotherapeutic support for treatment-resistant depressi...
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 participant...
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and post...
Recent advances in psychedelic research have renewed interest in their therapeutic potential for psychiatric disorders characterized by cognitive and behavioral rigidity. This review examines the rationale for using serotonergic psychedelics-particularly 5-HT2A receptor agonists such as psilocybin-in the treatment of eating disorders (EDs), including anorexi...
This study will examine the effects of psilocybin on Lyme disease symptom burden and quality of life in people with Post-Treatment Lyme Disease (PTLD). This pilot study will evaluate the therapeutic potential of psilocybin in people with well-documented current Post-Treatment Lyme Disease (PTLD). Study measures will assess the impact of psilocybin-assisted t...
IMPORTANCE: Psilocybin-assisted psychotherapy may offer a novel approach to treating depression, anxiety, and existential distress in individuals with life threatening illnesses, where current treatments show limited efficacy. OBJECTIVE: To evaluate the efficacy and safety of psilocybin-assisted psychotherapy versus active placebo and psychotherapy in adults...
IntroductionPsilocybin shows encouraging outcomes for patients with cancer and major depressive disorder (MDD). However, there is insufficient evidence on the use of evidence-based psychotherapeutic interventions to consistently guide and standardize psilocybin preparation, dosing, and integration. Meaning-centered psychotherapy (MCP) is a manualized, brief ...
The serotonergic psychedelic psilocybin induces neural plasticity and profoundly alters consciousness. The benzodiazepine midazolam blunts neural plasticity and induces conscious sedation and amnesia at low doses. In our recent open label pilot study, we administered oral psilocybin (25 mg) along with intravenous midazolam at doses allowing a full psychedeli...
BackgroundFluoxetine remains the only pharmacological treatment approved for Bulimia Nervosa, and no other drugs have been approved for eating disorders (EDs). The rationale for exploring psilocybin as a treatment for EDs is compelling, both from biological and psychological perspectives. Moreover, its safety profile in healthy individuals appears favorable....
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...
Background: Individuals with bipolar II disorder (BD-II) and depression face limited treatment options and are often excluded from psilocybin therapy trials due to theoretical concerns of precipitating mania or psychosis. Although psilocybin has demonstrated antidepressant effects when combined with psychotherapy, adverse event reporting is inconsistent, and...
