Clinical trials: Psilocybin
Opioid Use Disorder
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…
- Trial name
- NCT05242029
- Testing
- Psilocybin
- Sponsor
- Johns Hopkins University
Healthy
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common…
- Trial name
- MDMA-Psilo (NCT06884514)
- Testing
- Psilocybin, 3,4-Methylenedioxymethamphetamine
- Where
- Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Gambling Disorder
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder.
- Trial name
- PASSENGER (NCT07391332)
- Testing
- Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Nantes University Hospital
Alcohol Use Disorder (AUD)
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).
- Trial name
- NCT04718792
- Testing
- Psilocybin
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Anders Fink-Jensen, MD, DMSci
Psychological Distress
Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress.
- Trial name
- NCT07063862
- Testing
- Psilocybin
- Where
- 7 sites in Canada
- Volunteers
- 120 people
- Sponsor
- Bruyère Health Research Institute.
Alcohol Dependence
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence.
- Trial name
- NCT02061293
- Testing
- Psilocybin, Diphenhydramine, Motivational Enhancement and Taking Action (META)
- Where
- 2 sites in United States
- Volunteers
- 95 people
- Sponsor
- NYU Langone Health
Premenstrual Dysphoric Disorder ( PMDD), PMDD
MLS101 Study in PMDD
The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD).
- Trial name
- NCT07818720
- Testing
- MLS101 psilocybin
- Volunteers
- 32 people
- Sponsor
- MycoMedica Life Sciences PBC
Post-traumatic Stress Disorder, Depression
Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With 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.
- Trial name
- SUMMIT-90 (NCT06141876)
- Testing
- APEX-002-A02
- Volunteers
- 160 people
- Sponsor
- Apex Labs Ltd.
Psilocybin, Hallucinogens
Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
This is a pilot study to finalize methods for a larger study being planned for the future. This research is being done to characterize performance of tasks, brain functioning, and the effects of psilocybin in individuals with a…
- Conditions
- Psilocybin, Hallucinogens, Pharmacologic Actions, Central Nervous System Agents
- Trial name
- NCT01988311
- Testing
- psilocybin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05711940
- Testing
- Psilocybin
- Where
- 116 sites in United States, Canada and 10 more
- Volunteers
- 572 people
- Sponsor
- COMPASS Pathways
Migraine Headache
Repeat Dosing of Psilocybin in Migraine Headache
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.
- Trial name
- NCT04218539
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Yale University
Psychological Stress, Depression
Psilocybin-Assisted Therapy for Intergenerational Trauma
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.
- Conditions
- Psychological Stress, Depression, Anxiety
- Trial name
- NCT06899165
- Testing
- Psilocybin, Integration sessions
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Rachel Yehuda
Anorexia Nervosa
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)…
- Trial name
- NCT04505189
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Imperial College London
Aging, Longevity
Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life
The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults.
- Conditions
- Aging, Longevity, Biomarkers of Aging
- Trial name
- LONG-LIFE (NCT07719088)
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Charles Raison
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
PTSD, PTSD - Post Traumatic Stress Disorder
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm).
- Conditions
- PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression, Suicidality
- Trial name
- PRE-EMPT (NCT07745569)
- Testing
- Transcranial Magnetic Stimulation, Psilocybin (drug), Neurofeedback
- Volunteers
- 150 people
- Sponsor
- University of New Mexico
Major Depressive Disorder
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
- Trial name
- NCT05385783
- Testing
- CYB003, Psychotherapy, Psychological Support
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Cybin IRL Limited
Treatment Resistant Depression
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
- Trial name
- SYNVEST (NCT06512220)
- Testing
- Psilocybin 25 mg, Risperidone 1 MG
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Centre for Addiction and Mental Health
Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first…
- Trial name
- NCT06644170
- Testing
- Behavioral Intervention, Group Therapy, Psilocybin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Washington
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