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Executed search Journal: ClinicalTrials.gov 287 matching records are displayed.

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287 matching results

Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder

Effects of serotonin 2A/1A receptor stimulation by psilocybin on alcohol addicted patients: a randomized double-blind placebo-controlled study Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs). Of all the diseases, conditions...

ClinicalTrials.gov 2023-09-20 University of Zurich

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionMechanism of ActionReceptor PharmacologyAgingEmotional ProcessingClinical TrialObservational StudySafety Clinical Trial Alcohol Use DisorderPsilocybin

Phase 1, Open-Label, One-Treatment, Single-Dose, One-Period, Pharmacokinetic Study of Psilocin 4 mg as Its Mucic Acid Salt (L-130) Form, in Healthy Subjects Under Fasted Conditions

Psilocin is the active metabolite of psilocybin a natural material found in several types of fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been reported. This Phase I "First in Man" study of psilocin mucate is designed to determine ...

ClinicalTrials.gov 2023-09-12 Lobe Sciences Ltd.

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin AddictionPharmacologyClinical TrialSafetyAdverse Events Clinical Trial Side Effect of DrugPsilocin

A Phase 1, Two-Part Study in Healthy Volunteers to Evaluate The Effect of Psilocybin on Cardiac Repolarization and The Effect of Food on Psilocybin Pharmacokinetics

This study is comprised of two parts. The purpose of the first part of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization. The purpose of the second part of the study is to evaluate the effects of food on the pharmacokinetics of psilocybin. Part one of this study will be a double-blind, single-dose, rando...

ClinicalTrials.gov 2023-08-14 Usona Institute

ClinicalTrials.gov CLINICAL TRIAL psilocybin PharmacologyClinical TrialHealthy Volunteers Clinical Trial QTc IntervalPharmacokinetics

The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study

The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating...

ClinicalTrials.gov 2023-07-26 Brain and Cognition Discovery Foundation

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionClinical TrialTreatment-Resistant DepressionSafetyAdverse Events Clinical Trial Treatment Resistant DepressionPsilocybin

An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.

The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therap...

ClinicalTrials.gov 2023-07-24 The Roots to Thrive Society for Psychedelic Therapy

ClinicalTrials.gov CLINICAL TRIAL psilocybin End-of-Life DistressWellbeingResilienceObservational StudySafetyAdverse Events Observational Study End of LifePsilocybin-assisted therapy within a community of practice model (group administered)

Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD)

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will ...

ClinicalTrials.gov 2023-07-05 Cybin Therapeutics Inc.

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionReceptor Pharmacology Other DepressionMajor Depressive Disorder

Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United...

ClinicalTrials.gov 2023-06-28 Halucenex Life Sciences Inc.

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyPTSDNeuroplasticityNeurogenesisReceptor PharmacologyClinical TrialAnimal StudySafety Clinical Trial Treatment Resistant DisordersPost Traumatic Stress Disorder

Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to Pa...

ClinicalTrials.gov 2023-05-24 Combat Stress

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyPTSDTreatment-Resistant DepressionVeteransSafety Other PTSDPsilocybin

Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This...

ClinicalTrials.gov 2023-05-18 University of Wisconsin, Madison

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAddictionClinical TrialHealthy VolunteersSafety Clinical Trial Psychedelic ExperiencesAmnesia

A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin

The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks. Psilocybin, ...

ClinicalTrials.gov 2023-05-14 University of Wisconsin, Madison

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionAnxietyAddictionPharmacologyClinical TrialCancer PatientsTreatment-Resistant DepressionSafetyAdverse Events Clinical Trial HealthyOral Psilocybin

Effects of Psilocybin in Anorexia Nervosa

This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely pro...

ClinicalTrials.gov 2023-05-05 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyEating DisordersSafety Other Anorexia NervosaPsilocybin

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

ClinicalTrials.gov 2023-04-23 COMPASS Pathways

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionSafety Other Treatment Resistant DepressionPsilocybin

Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness

Mescaline (the active substance in Peyote and San Pedro cacti) is a classic and long known serotonergic psychedelic substance (hallucinogen) that is widely used for recreational, spiritual, and/or ethno medical purposes. Despite its long history, modern data on the acute effects of mescaline on human is lacking. Mescaline produces prototypical psychedelic ef...

ClinicalTrials.gov 2023-03-28 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin Receptor PharmacologyConsciousnessSpiritualityHealthy Volunteers Other HealthyPlacebo

Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects ("MELO"): A Blinded, Placebo-Controlled, Dose-Finding Study

This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic effects. Psilocybin is a natural psychoactive alkaloid component of more than 200 species of naturally growing mushrooms that can be foun...

ClinicalTrials.gov 2023-03-19 Optimi Health Corporation

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionAnxietyMicrodosingWellbeingSafetyToxicity Clinical Trial Mood DisturbanceMood Change

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period. In this pilot study, up to 12 adult outpati...

ClinicalTrials.gov 2023-03-12 New York State Psychiatric Institute

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionBrain ImagingReceptor PharmacologyAgingSafety Other Body Dysmorphic DisordersPsilocybin

SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression

Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, ...

ClinicalTrials.gov 2023-01-29 Washington University School of Medicine

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionNeuroplasticityBrain ImagingReceptor PharmacologyBiomarkersAgingClinical TrialAnimal Study Clinical Trial Major Depressive DisorderAnhedonia

Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder

Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The pur...

ClinicalTrials.gov 2023-01-16 Keith Heinzerling

ClinicalTrials.gov CLINICAL TRIAL psilocybin AnxietyAddictionMystical ExperienceClinical TrialReview ArticleSafety Clinical Trial Alcohol Use DisorderPsilocybin plus Visual Healing Set and Setting

NW Trauma Therapies, Chronic Illness of Chronic Depression, PTSD, MS, HIV, and SARS-CoV-2, Long Haulers Syndrome. Treatment of Unregulaaible Trauma by the Treatment of Enhanced Micro Dosing the Levels of 0.15, Thru 0.33, With a Maintenance Dose of 1 Gram Per Month for Neural Pathway Increase of Non Synthesized Psilocybin, Using the Actual Plant to Regulate the Highjacked Nervous System.

The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many...

ClinicalTrials.gov 2022-11-15 NWTraumatherapies

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionPTSDEnd-of-Life DistressMechanism of ActionReceptor PharmacologyMicrodosingImmune Function Other TraumaNervous System

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context ...

ClinicalTrials.gov 2022-11-07 NYU Langone Health

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionSpiritualitySafety Other Alcohol DependencePsilocybin

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.

ClinicalTrials.gov 2022-10-24 Sheppard Pratt Health System

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionSafety Other Treatment Resistant DepressionPsilocybin

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Source	Count	Share	Status
Europe PMC	2,554	64.3%	Active
PubMed	302	7.6%	Active
ClinicalTrials.gov	287	7.2%	Active
OpenAlex	283	7.1%	Active
PsyArXiv	216	5.4%	Active
Crossref	157	3.9%	Active
bioRxiv	142	3.6%	Active

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