Clinical trials: Psilocybin
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
Opioid Use Disorder
Psilocybin for Opioid Use Disorder (OUD)
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who…
- Trial name
- NCT06796062
- Testing
- Psilocybin
- Where
- 5 sites in United States
- Volunteers
- 480 people
- Sponsor
- NYU Langone Health
PTSD
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with…
- Trial name
- STARLIGHT (NCT06888128)
- Testing
- Psilocybin 15mg, Psilocybin 25mg
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Baylor College of Medicine
Treatment Resistant Depression, Suicidal Ideation
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
- Trial name
- NCT05220410
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sheppard Pratt Health System
Stuttering
Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter
This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with…
- Trial name
- NCT07296328
- Testing
- Psilocybin, Speech therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NYU Langone Health
Self Harm
PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm
Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide.
- Trial name
- PsiloIMAGINE (NCT06798636)
- Testing
- Psilocybin 5 mg with cognitive behavioural therapy intervention
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Imperial College London
Opioid Dependence, Chronic Pain
Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication
This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients…
- Trial name
- NCT05585229
- Testing
- Psilocybin-assisted Psychotherapy
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- University of British Columbia
Alcohol Use Disorder, Alcohol Dependence
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD).
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
- Trial name
- Psi or Ket (NCT06405607)
- Testing
- Psilocybin, Ketamine
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Iowa
Treatment Resistant Depression, MDD
Psilocybin rTMS for Treatment Resistant Depression
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with…
- Conditions
- Treatment Resistant Depression, MDD, Major Depressive Disorder, Recurrent Depression
- Trial name
- PSILOBSD (NCT06132178)
- Testing
- Psilocybin, Accelerated intermittent theta burst (aiTBS) rTMS treatment, Low-dose psilocybin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Texas at Austin
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
Demoralization
Pragmatic Trial of Psilocybin Therapy in Palliative Care
This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years…
- Trial name
- PT2PC (NCT05403086)
- Testing
- Psilocybin, Ketamine
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Charles S. Grob, M.D.
Obsessive-compulsive Disorder
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals.
- Trial name
- NCT04882839
- Testing
- psychotherapy assisted psilocybin
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Beersheva Mental Health Center
Healthy
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy…
- Trial name
- NCT06081179
- Testing
- Psilocybin, 3,4 Methylenedioxymethamphetamine, Methylphenidate
- Where
- Switzerland
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Treatment Resistant Depression
Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression
Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to…
- Trial name
- NCT07183748
- Testing
- Psilocybin (drug)
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Beersheva Mental Health Center
Alcohol Use Disorder
Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use.
- Trial name
- NCT05421065
- Testing
- Psilocybin, Ketamine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Peggy C Nopoulos
Major Depressive Disorder
Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder.
- Trial name
- NCT03554174
- Testing
- Low Dose Psilocybin, Medium Dose Psilocybin
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Yale University
Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm
Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression.
- Trial name
- NCT05847686
- Testing
- Counseling, Psilocybin, Questionnaire Administration
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- University of Washington
Psilocybin
Precision Functional Brain Mapping in Psilocybin
This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain networks in healthy adults.
- Trial name
- Psilocybin PFM (NCT04501653)
- Testing
- Psilocybin, Methylphenidate
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Opioid Use Disorder
Wellcome Leap Psilocybin for OUD
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical…
- Trial name
- NCT06786325
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Anna Rose Childress, Ph.D.
Aging
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults.
- Trial name
- NCT06367738
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley