Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (Phase 2, Johns Hopkins University, completed) — This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD).…
Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy (Phase 2, Kyle Greenway, n=16, recruiting) — The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences.…
Mechanistic Studies of Psilocybin in Headache Disorders (Observational, Yale University, n=50, recruiting) — In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect.…
Psilocybin-assisted Interpersonal Therapy for Depression (Observational, University of Otago, n=5, completed) — This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin.
Prophylactic Effects of Psilocybin on Chronic Cluster Headache (Phase 1, Gitte Moos Knudsen, n=10, completed) — The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week.…
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD (Phase 2, Beersheva Mental Health Center, n=15, recruiting) — Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment .…
Psilocybin for Treatment-Resistant Depression (Phase 2, Brain and Cognition Discovery Foundation, n=30, completed) — The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression.…
Psilocybin for the Treatment of Migraine Headache (Phase 1, Yale University, n=14, completed) — 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.…
Study results of psilocybin treatment in bipolar II depression published in JAMA Psychiatry (Phase 2, Sheppard Pratt, n=15) — An investigator-initiated open-label study of COMP360 psilocybin treatment in 15 participants with treatment-resistant bipolar II depression showed a significant reduction in depressive symptoms, with 12 participants meeting response criteria and 11 meeting remission criteria. No increase in suicidality, manic symptoms, or unexpected adverse events were reported.
Magic mushrooms may reshape the brain long after the trip ends (Observational, University of California - San Francisco, n=28) — A single dose of psilocybin produced measurable changes in brain activity and possible changes in brain structure that lasted for up to a month. Participants who experienced the greatest increase in flexible, varied brain activity also reported more personal insight and later improvements in well-being.
What Does a Dose of Magic Mushrooms Actually Do to Your Brain? (News) — # What does a dose of magic mushrooms actually do to your brain? A study has found one single dose of magic mushrooms can transform the brain physically — with changes lasting as long as a month.…
Psychedelic drugs are showing promise in treating mental health conditions (News) — Psychedelic drugs like psilocybin are being studied for their potential to treat mental health conditions such as depression and PTSD. Early research suggests these substances, when used in controlled therapeutic settings, may offer new avenues for treatment.
MDMA
Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing (Observational, University Hospital, Basel, Switzerland, n=28, completed) — The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation on empathy, mood perception, and amygdala activity to fearful stimuli.…
Clinical Trial of MDMA-Assisted Therapy for Military Service Members With Posttraumatic Stress Disorder (Phase 2, U.S. Army Medical Research and Development Command, n=86, recruiting) — This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.…
The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD. (Phase 1, Yale University, completed) — This study aims to investigate the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD.
Effects of Intranasal Ketamine on Depression and Anxiety in Palliative Care Cancer Patients (Observational, University of Zurich, n=100, recruiting) — With progression of cancer, patients and their caregivers experience challenging emotional distress, which can make them feel depressed and very anxious. Patients with advanced cancer often do not have long to live.…
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants (Phase 1, Janssen Research & Development, LLC, n=17, completed) — The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
Intravenous Ketamine Plus Neurocognitive Training for Depression (Phase 1, Rebecca Price, n=154, completed) — This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training.…
Ketamine Treatment Plans for Chronic Conditions (Observational, RIVER Foundation, n=500, recruiting) — A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder (Phase 1, VA Office of Research and Development, n=65, completed) — The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial.…
A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants (Phase 1, Janssen Research & Development, LLC, n=34, completed) — The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.
Low-dose S-ketamine in Women With Prenatal Depression (Observational, Peking University First Hospital, n=364, completed) — Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression.…
A Single Ketamine Infusion Combined With Music for Suicidal Ideation (Phase 2, The University of Texas Health Science Center at Tyler, n=200, active) — Suicidal ideation (SI) associated with major and bipolar depression is commonly seen in a wide range of clinical practice situations including the emergency room (ER). Current treatment regimens are often unsatisfactory.…
IV Ketamine vs. IN Esketamine for MDD TRD (Observational, Gustavo Vazquez, n=80, recruiting) — The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations.…
Ketamine for the Treatment for Alcohol Use Disorder in the ED (Phase 2, Brigham and Women's Hospital, completed) — The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo.…
Mood Effects of Serotonin Agonists (Phase 1, University of Chicago, n=80, completed) — The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.
The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers (Observational, Psychiatric University Hospital, Zurich, n=25, completed) — Aim of the present study is to investigate the neuronal correlates of self and of personal meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.
DMT
Safety and Pharmacokinetics of GH002 in Healthy Volunteers (Phase 1, GH Research Ireland Limited, n=64, completed) — The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002.…
What Is Ibogaine? Trump Admin Fast-Tracks Psychoactive Drug for Approval (News) — Ibogaine, a psychoactive compound derived from the Tabernanthe iboga shrub, is being studied as a potential treatment for addiction, PTSD, and depression. While supporters see it as a breakthrough, researchers caution about limited evidence and serious safety risks, including heart problems. The Trump administration is accelerating research and review pathways for ibogaine compounds.
Trump signs executive order accelerating research into psychedelic drug therapies (Regulatory) — President Trump signed an executive order to accelerate research and approval of psychedelic-based therapies, particularly ibogaine, for conditions like PTSD, depression, and addiction. The order aims to help veterans with severe mental health issues by providing new treatment options.
Trump accelerates research on psychedelic treatments and asks, ‘Can I have some?’ (News, HHS) — President Trump signed an executive order to encourage expanded research into psychedelic drugs, including a $50 million investment for ibogaine research. The order aims to accelerate research approval and access to new mental health treatments, potentially moving drug approvals from over a year to weeks.
Other
Psychedelics Deserve Real Science (News) — On April 18, 2026, President Donald Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness.”6 The order directs the FDA to issue National Priority Vouchers for Breakthrough Therapy-designated psychedelics, targets a 1- to 2-month review timeline, creates patient access pathways under the Right to Try Act, and mandates rescheduling on the heels of successful phase 3 trials.…
How Trump’s executive order could accelerate widespread access to psychedelic therapies (News) — President Trump issued an executive order directing federal agencies to accelerate access to psychedelic drugs, including ibogaine, psilocybin, and LSD, as potential treatments for serious mental illnesses. The order aims to expedite FDA reviews for qualifying psychedelic drugs and create pathways for access under the Right to Try Act.