Clinical trials: Psilocybin, open to volunteers
Alzheimer's Disease
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking.
- Trial name
- NCT07721467
- Testing
- Psilocybin, Cognitive Training
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI
Psilocybin Microdosing on Cognition, Mood and Quality of Life
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo.
- Trial name
- NCT07449351
- Testing
- Psliocybin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yale University
Depressive Disorder
Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a…
- Trial name
- COGUNILA (NCT06898606)
- Testing
- Psilocybin and Psilocyn, Psychotherapy-assisted session, Fluoxetine
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Federal University of Latin American Integration
Caregiver Distress
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer
The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.
- Trial name
- PEARL-C1 (NCT07048743)
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Depression - Major Depressive Disorder, Anhedonia
Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1.
- Trial name
- NCT07490353
- Testing
- Psilocybin (Usona Institute), Risperidone 1 MG, MRI
- Where
- Austria
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Healthy
Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs
This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences.
- Trial name
- (DIPP-RCFT) (NCT06815653)
- Testing
- Psilocybin 25mg
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University College, London
Healthy Adults
Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.
Self-awareness, the capacity of becoming the object of one's own awareness, is a frontier of scientific knowledge. Over centuries, distinct philosophical and religious traditions have grappled with the subject, but only recently…
- Trial name
- NCT07732166
- Testing
- Psilocybin (Usona Institute), Niacin 100 mg
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Pontifícia Universidade Católica do Rio de Janeiro
Healthy Volunteer, Older Adults (65-85 Years)
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
- Trial name
- Psil-Pk (NCT07516405)
- Testing
- Psilocybin (Usona Institute)
- Where
- 6 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Perception Disorders
Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain
The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment.
- Trial name
- NCT05265546
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Mood (Psychological Function), Well Being
Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo.
- Conditions
- Mood (Psychological Function), Well Being, Mood, Healthy
- Trial name
- PRISMatic (NCT07610135)
- Testing
- Psilocybin, Pimavanserin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Phase I
Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation
The primary aim of this phase I mechanistic pilot study is to evaluate the effects of psilocybin on aspects of cognition in healthy adult volunteers.
- Trial name
- NCT07818564
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Brown University
Healthy
Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants
The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin.
- Trial name
- LPD (NCT06899334)
- Testing
- LSD, Psilocybin, DMT
- Where
- Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Healthy Volunteers
Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1.
- Trial name
- NCT07079930
- Testing
- Psilocybin and D-Serine, Physical Examination, Vital signs
- Where
- Israel
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Psilocybin Intoxication
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
This study will evaluate the subjective and behavioral effects of psilocybin relative to placebo and alcohol.
- Trial name
- NCT07877987
- Testing
- 0mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 1mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink, 5mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Psychedelic Effects in Healthy Volunteers
Psilocybin Administration With 5-HT1a Blockade
The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG).
- Trial name
- PsilBlock1 (NCT07565493)
- Testing
- Pindolol, Psilocybin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Psilocybin
The RECAP2 Study: Midazolam and Psilocybin
The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in…
- Trial name
- NCT06692192
- Testing
- Psilocybin, Midazolam, Saline
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Psilocybin, Music Intervention
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75.
- Trial name
- PRoMiSS (NCT07180108)
- Testing
- Psilocybin (high dose), Playlist 1, Playlist 2
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Mental Health
Mindfulness-Assisted Psychedelic Therapy
The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy…
- Trial name
- MAPT (NCT06233344)
- Testing
- Psilocybin plus mindfulness training, Psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Transdiagnostic, Depression - Major Depressive Disorder
Open-Label Psilocybin Study in Transdiagnostic Population
The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms.
- Conditions
- Transdiagnostic, Depression - Major Depressive Disorder, Anxiety, PTSD Symptoms
- Trial name
- NCT06442423
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yale University
Healthy Participants, Placebo - Control
The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.
In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug).
- Conditions
- Healthy Participants, Placebo - Control, Psilocybin
- Trial name
- PSILOBIOMARKER (NCT07433452)
- Testing
- Psilocybin (drug)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Gabriella Gobbi