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287 matching results

An Open-Label Investigation of the Effects of Sub-Perceptual Repeat Dosing of Psilocybin on the Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients

Diverse symptomatology makes Fragile X Syndrome (FXS) difficult to treat, and currently there are no approved prevention or treatment methods for FXS. Current therapies, including pharmaceutical and behavioural interventions, offer a patchwork of solutions that have limited efficacy and high toxicity. The current study aims to examine psilocybin as a safe tr...

ClinicalTrials.gov 2024-05-07 Nova Mentis Life Science Corp

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyNeuroplasticityReceptor PharmacologyBiomarkersMicrodosingReview ArticleHealthcare WorkersToxicityInflammation Review Article Fragile X SyndromeBehavior

Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial

The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD). The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement ther...

ClinicalTrials.gov 2024-05-06 University of Calgary

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionBrain ImagingMechanism of ActionAgingClinical Trial Clinical Trial Alcohol Use DisorderAlcoholism

Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range. Thus, different doses will be tested and ...

ClinicalTrials.gov 2024-04-24 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin ConsciousnessSpirituality Clinical Trial HealthyN

The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density - A Single Dose Randomized, Double Blind, Placebo- Controlled Phase 2 Positron Emission Tomography Study

PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms Psykiat...

ClinicalTrials.gov 2024-04-18 Section for Affective Disorders; Northern Stockholm Psychiatry

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyNeuroplasticityBrain ImagingAgingClinical TrialHealthy VolunteersSafety Clinical Trial Major Depressive DisorderDepression

Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)

The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in...

ClinicalTrials.gov 2024-04-01 University Health Network, Toronto

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionClinical TrialObservational StudyTreatment-Resistant DepressionSafetyAdverse Events Clinical Trial Major Depressive DisorderDepression

A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of ...

ClinicalTrials.gov 2024-03-19 University of Utah

ClinicalTrials.gov CLINICAL TRIAL psilocybin Safety Other CancerPsilocybin

Repeat Dosing of Psilocybin in Headache Disorders

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. Migraine headache is a common medical condition...

ClinicalTrials.gov 2024-02-08 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineBiomarkersInflammation Other Migraine HeadachePsilocybin

A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

This study will investigate whether psilocybin administered under supportive conditions can reduce illicit opioid use and improve quality of life in individuals with Opioid Use Disorder (OUD) in Methadone Maintenance Treatment (MMT) who are concurrently using other opioids illicitly. This randomized double-blind placebo-controlled trial will investigate whet...

ClinicalTrials.gov 2024-02-01 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionChronic PainToxicity Clinical Trial Opioid Use DisorderPlacebo

Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects

LSD, psilocybin and mescaline are widely used for recreational and ethnomedical purposes. All three substances are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in the substances' molecular structures and receptor activation profiles which may induce differential subjective...

ClinicalTrials.gov 2024-01-23 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingReceptor PharmacologyConsciousnessAgingToxicity Qualitative Study HealthyLSD

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD

This open-label fMRI study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with treatment-resistant major depressive disorder.

ClinicalTrials.gov 2024-01-23 Massachusetts General Hospital

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionBrain Imaging Other Treatment-Resistant Major Depressive DisorderPsilocybin

Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action

The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia. This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, ...

ClinicalTrials.gov 2024-01-18 Imperial College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin NeuroplasticityBrain ImagingBiomarkersObservational Study Observational Study FibromyalgiaPsilocybin

Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD. The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduc...

ClinicalTrials.gov 2024-01-04 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin PTSDClinical TrialSafety Clinical Trial Post-Traumatic Stress DisorderPsilocybin

Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.

This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after...

ClinicalTrials.gov 2023-12-25 Multidisciplinary Association for Psychedelic Studies

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAgingSpiritualityMystical ExperienceSafetyImmune Function Clinical Trial AnxietyStage IV Melanoma

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders

The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in or...

ClinicalTrials.gov 2023-12-14 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineSafety Clinical Trial Cluster Headache0.143 mg/kg Psilocybin or 10 mg Psilocybin

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).

Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is...

ClinicalTrials.gov 2023-11-28 Apex Labs Ltd.

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyPTSDAddictionOCDSafetyAdverse Events Clinical Trial Post-traumatic Stress DisorderDepression

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40...

ClinicalTrials.gov 2023-11-08 COMPASS Pathways

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

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II

The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document heada...

ClinicalTrials.gov 2023-10-11 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineSafetyInflammation Clinical Trial Post-Traumatic HeadachePlacebo oral capsule

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache d...

ClinicalTrials.gov 2023-10-11 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineSafety Clinical Trial Migraine HeadacheHigh Dose Psilocybin

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in ...

ClinicalTrials.gov 2023-09-25 University of New Mexico

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietySpiritualitySafety Other Alcohol DependencePsilocybin

Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators

The investigators are doing this project to investigate potential neurophysiological synergy effects between mindfulness meditation and psychedelics. Previous studies have found that both mindfulness and psychedelics like psilocybin modulate neural activity and connectivity of the same brain network. However, little is known about the potential interactions ...

ClinicalTrials.gov 2023-09-20 Milan Scheidegger

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingReceptor PharmacologyConsciousnessAgingHealthy VolunteersDrug Interactions Other Healthy ParticipantsDMT + harmine

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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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