Psilocybin clinical trials, in English

The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active dummy treatment (placebo) (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

NCT05398484 · Official ClinicalTrials.gov record · NYU Langone Health

This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.

NCT05866471 · Official ClinicalTrials.gov record · University of Wisconsin, Madison

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.

NCT06200155 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

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. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing.

NCT06442423 · Official ClinicalTrials.gov record · Yale University

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.

NCT06512220 · Official ClinicalTrials.gov record · Centre for Addiction and Mental Health

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects. this study wants to assess the feasibility, tolerability, and preliminary how well it works of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.

NCT06518720 · Official ClinicalTrials.gov record · Centre for Addiction and Mental Health

This is an treatment, parallel arm assignment treatment study in individuals with Major Depressive Disorder (major depression). Each individual will be treated with a single dose of pimavanserin or dummy treatment (placebo) plus a single dose of psilocybin.

NCT06592833 · Official ClinicalTrials.gov record · Icahn School of Medicine at Mount Sinai

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 emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or dummy treatment (placebo) to see what dose induces increased wellbeing.

NCT06692192 · Official ClinicalTrials.gov record · University of Wisconsin, Madison

This study wants to determine the how well it works, whether it is safe and how hard side effects are to live with of CYB003 compared to matching dummy treatment (placebo) as added on top of your current treatment treatment in patients with major depression. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

NCT06793397 · Official ClinicalTrials.gov record · Cybin IRL Limited

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

NCT06801041 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active dummy treatment (placebo) (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e.

NCT06943573 · Official ClinicalTrials.gov record · Lakshmi N Yatham

This Phase 2a clinical trial is designed to measure the safety, tolerability, and preliminary how well it works of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), neither you nor the study doctors know who gets the real treatment Treatment Phase (4 weeks) Screening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility.

NCT06969170 · Official ClinicalTrials.gov record · Claudio N Soares

The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).

NCT06988319 · Official ClinicalTrials.gov record · Oregon Health and Science University

This study is assessing the how well it works and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis.

NCT07072728 · Official ClinicalTrials.gov record · Psyence Australia Pty Ltd

The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomly assigned, controlled study in participants with PTSD.

NCT07104916 · Official ClinicalTrials.gov record · Anthony P King

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. The main questions it aims to answer are: Does autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists?

NCT07180108 · Official ClinicalTrials.gov record · Johns Hopkins University

Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed.

NCT07210112 · Official ClinicalTrials.gov record · Centre Hospitalier St Anne

The purpose of this multi-site randomly assigned controlled trial is to measure the how well it works and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

NCT07226232 · Official ClinicalTrials.gov record · VA Office of Research and Development

This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to measure the safety, feasibility, and preliminary how well it works of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical outcomes in individuals who stutter, is warranted.

NCT07296328 · Official ClinicalTrials.gov record · NYU Langone Health

This pilot study will examine the safety, tolerability, acceptability, and how well it works of combination psilocybin + psychotherapy to decrease PTSD symptoms. you would be randomly assigned into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.

NCT07332143 · Official ClinicalTrials.gov record · Emory University

This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1.

NCT07386730 · Official ClinicalTrials.gov record · Jennifer Mitchell

The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomly assigned clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol.

NCT07391332 · Official ClinicalTrials.gov record · Nantes University Hospital

The goal of this clinical trial is to determine the safety and how well it works of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (major depression) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \- What is the feasibility and safety of administering PAT in adults with major depression-AUD by evaluating recruitment, retention, tolerability, and safety?

NCT07405606 · Official ClinicalTrials.gov record · Centre for Addiction and Mental Health

This study plans to learn more about the whether it is safe and how hard side effects are to live with of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

NCT07516405 · Official ClinicalTrials.gov record · University of Colorado, Denver

This study wants 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). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.

NCT07565493 · Official ClinicalTrials.gov record · Johns Hopkins University

The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.

NCT07570654 · Official ClinicalTrials.gov record · COMPASS Pathways

This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting. The study will test whether a single 25 mg dose of psilocybin, compared with dummy treatment (placebo), can improve these symptoms and improve the function of brain circuits involved in reward and motivation.

NCT07607938 · Official ClinicalTrials.gov record · NYU Langone Health

Twenty healthy adults (≥21 years old) will be enrolled to measure the how well it works of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or dummy treatment (placebo). Outcome assessments will occur at 1 week and 1 month following psilocybin administration.

NCT07610135 · Official ClinicalTrials.gov record · Johns Hopkins University

This study wants to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

NCT07610369 · Official ClinicalTrials.gov record · Yale University

Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults.

NCT07721467 · Official ClinicalTrials.gov record · National Institute on Aging (NIA)

The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are: * Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?

NCT07756736 · Official ClinicalTrials.gov record · Nicky Mehtani, MD, MPH

The primary aim of this phase I mechanistic pilot study is to measure the effects of psilocybin on aspects of cognition in healthy adult volunteers. Up to 24 participants will receive a single dose of either psilocybin or inert dummy treatment (placebo), and they will be asked to complete several computer-based behavioral tasks measuring features of learning, belief updating, and abstraction.

NCT07818564 · Official ClinicalTrials.gov record · Brown University

This study wants to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms.

NCT07920081 · Official ClinicalTrials.gov record · Johns Hopkins University