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287 matching results

PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (MBSR) for Front-line Healthcare Provider COVID-19 Related Burnout

This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic. Following consenting and ...

ClinicalTrials.gov 2024-11-11 University of Utah

ClinicalTrials.gov CLINICAL TRIAL psilocybin Depression Clinical Trial DepressionBurnout

PsilOCD: Evaluating the Effects of the 5-HT2A Agonist Psilocybin on the Neurocognitive and Clinical Correlates of Compulsivity (A Pharmacological-Challenge Feasibility Study)

The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD). This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four we...

ClinicalTrials.gov 2024-11-05 Imperial College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin OCDNeuroplasticityBrain ImagingReceptor PharmacologyBiomarkersObservational StudySafetyInflammation Observational Study Obsessive-Compulsive DisorderPsilocybin (COMP360)

A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study

The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX...

ClinicalTrials.gov 2024-10-29 Filament Health Corp.

ClinicalTrials.gov CLINICAL TRIAL psilocybin Clinical TrialSafety Clinical Trial Stimulant Use DisorderPEX010-Assisted Therapy

Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).

ClinicalTrials.gov 2024-10-23 Imperial College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionMechanism of ActionReceptor PharmacologyClinical Trial Clinical Trial Depressive DisorderMajor

Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression: An Emotional-Processing fMRI Pilot Study

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...

ClinicalTrials.gov 2024-10-17 University Health Network, Toronto

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionBrain ImagingMechanism of ActionReceptor PharmacologyConsciousnessAgingEmotional ProcessingClinical TrialRandomized Controlled TrialHealthy VolunteersTreatment-Resistant Depression Randomized Controlled Trial Bipolar DepressionPsilocybin

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 (psilocybin) in Healthy Participants

MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult p...

ClinicalTrials.gov 2024-10-08 MycoMedica Life Sciences PBC

ClinicalTrials.gov CLINICAL TRIAL psilocybin PharmacologyMicrodosingClinical TrialHealthy VolunteersSafety Clinical Trial Healthy VolunteersPsilocybin

The Effects of Psilocybin on Shared Experience in Film Processing

The goal of this clinical trial is to learn whether certain methods of detecting awareness in vegetative or minimally conscious patients (using neuroimaging) are sensitive to the effects of psilocybin (a psychedelic drug). One of these methods includes scanning peoples\' brains while they watch a film. When different individuals watch a film, their brains be...

ClinicalTrials.gov 2024-09-26 Western University, Canada

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingConsciousnessAgingClinical TrialHealthy Volunteers Clinical Trial Disorders of ConsciousnessPsychedelic Experiences

An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder. The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD...

ClinicalTrials.gov 2024-09-24 University of California, San Francisco

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionHealthcare WorkersSafety Other Bipolar II DisorderPsilocybin therapy

Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. The proposed study will assess the safety, feasibility, preliminary results and neurological aspects of psilocybin-assisted psychotherapy in the treatment of hospitalized patients wi...

ClinicalTrials.gov 2024-09-18 University Hospital, Ghent

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyBrain ImagingObservational StudyTreatment-Resistant DepressionSafetyToxicity Clinical Trial Treatment Resistant DepressionPsilocybin

Psilocybin for Treatment of Obsessive Compulsive Disorder

This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works. The study seeks to improve our ability to treat and improve the lives of people who have obsessive-compulsive disorder (OCD) by...

ClinicalTrials.gov 2024-08-29 University of Arizona

ClinicalTrials.gov CLINICAL TRIAL psilocybin AnxietyOCDMechanism of Action Clinical Trial Obsessive-compulsive Disorder (OCD)Psilocybin 100 mcg/kg

A24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are: * Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? * Is treatment with psilocybin and therapy safe for...

ClinicalTrials.gov 2024-08-14 Clairvoyant Therapeutics

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionClinical TrialSafety Clinical Trial Alcohol Use DisorderPsilocybin

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

ClinicalTrials.gov 2024-08-08 Sheppard Pratt Health System

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionTreatment-Resistant DepressionSafety Other Treatment Resistant DepressionPsilocybin

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical Trial

The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...

ClinicalTrials.gov 2024-08-08 Ottawa Hospital Research Institute

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyEnd-of-Life DistressReceptor PharmacologyAgingMicrodosingWellbeingEmotional ProcessingClinical TrialRandomized Controlled TrialCancer PatientsHealthcare WorkersSafetyAdverse Events Randomized Controlled Trial DepressionAnxiety

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial A substantial proportion of patients with alcohol use disorder does not respond to available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assist...

ClinicalTrials.gov 2024-08-06 Brugmann University Hospital

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionNeuroplasticityMechanism of ActionBiomarkersClinical TrialSafety Clinical Trial Severe Alcohol Use DisorderPsilocybin (high dose)

Psilocybin for the Treatment of Major Depressive Disorder

The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.

ClinicalTrials.gov 2024-07-24 Washington University School of Medicine

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionMechanism of Action Other Major Depressive DisorderPsilocybin

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate...

ClinicalTrials.gov 2024-07-11 Anders Fink-Jensen, MD, DMSci

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin AddictionPharmacologyReceptor PharmacologySafetyAdverse Events Other Alcohol Use Disorder (AUD)Psilocybin

Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders

This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion,...

ClinicalTrials.gov 2024-06-23 Empower Research Inc

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin ResilienceHealthcare Workers Clinical Trial PsilocybinPsychotherapy

Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion

The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.

ClinicalTrials.gov 2024-06-17 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin General Other HealthyPsilocybin

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group. Anorexia nervosa is the most fatal of all ...

ClinicalTrials.gov 2024-06-16 Imperial College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin Eating DisordersBrain ImagingAging Other Anorexia NervosaPsilocybin

A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder

To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial. New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy...

ClinicalTrials.gov 2024-06-09 University of Sydney

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionWellbeingClinical TrialRandomized Controlled TrialSafety Randomized Controlled Trial Alcohol Use DisorderAlcohol Dependence

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