Psilocybin's effect on human brain synaptic plasticity. (Phase 2) — Psychedelics such as psilocybin have been linked to enhanced neuroplasticity and symptom relief in affective disorders, but the neurobiological mechanisms and impact of environmental context remain unclear.…
Psilocybin-induced behavioral and cellular effects. (Phase 2) — Psilocybin, a prominent psychedelic, recently emerged as a potential therapeutic agent for psychiatric disorders, yet the molecular and cellular mechanisms driving its effects remain poorly understood.…
The RECAP2 Study: Midazolam and Psilocybin (Phase 1, University of Wisconsin, Madison, n=60, recruiting) — 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.…
Effects of SERT Inhibition on the Subjective Response to Psilocybin in Healthy Subjects (Phase 1, University Hospital, Basel, Switzerland, n=27, completed) — Psilocybin is a classic serotonergic hallucinogen acting on the 5-HT2A receptor. It is used recreationally and in psychiatric research. Selective serotonin reuptake inhibitors (SSRIs) like escitalopram are first-line treatments for depression. They inhibit the serotonin transporter (SERT).…
Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN (Phase 2, Unity Health Toronto, n=30, recruiting) — This is a feasibility study to examine the use of use of Psilocybin (magic mushrooms) to alleviate pain in chronic neuropathic pain. While theoretical mechanisms demonstrate promise, there is no clinical evidence.…
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression (Phase 3, VA Office of Research and Development, n=240, recruiting) — The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.
Persisting Effects of Psilocybin (Phase 1, Johns Hopkins University, n=13, completed) — The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin) leads to changes in emotion processing and neural circuitry that may predict repeated self-administration of this drug and underlie an atypical mechanism of abuse liability, which may vitally contribute to the understanding of the potential for abuse and the underlying mechanisms supporting abuse of classic hallucinogens.
Safety Profile of Psilocybin for Cocaine Use Disorder (Observational, University of California, Los Angeles, n=10, active) — The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects.…
Psilocybin as serotonergic therapy in epilepsy: Narrative review of potentials and limitations. (Meta-analysis) — Psilocybin shows potential in neuropsychiatric disorders but has a complex relationship with epilepsy and seizures. We reviewed literature up to November 2025 to identify studies relevant to psilocybin's effects on seizures and epilepsy, including our research on serotonergic modulation.…
Psilocybin in Chronic Low Back Pain and Depression (Phase 1, Johns Hopkins University, n=40, recruiting) — This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose).…
The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder (Phase 2, Maryland Oncology Hematology, PA, n=30, active) — This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm.…
Psilocybin Therapy for Psychological Distress in Palliative Patients (Phase 2, University Medical Center Groningen, n=108, recruiting) — The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy.…
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder (Phase 2, Brigham and Women's Hospital, n=36, recruiting) — This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial.…
Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder. (Phase 1, Francisco A Moreno, n=30, recruiting) — The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD.…
Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life (Phase 1, Charles Raison, n=50, recruiting) — 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.…
Psilocybin-assisted CBT for Depression (Phase 1, University of California, Los Angeles, n=16, completed) — The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder.…
Psilocybin After Trauma Surgery for Pain (Phase 1, Trent Emerick, n=70, recruiting) — The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are: 1.…
Bioavailability Study of Psilocybin in Normal Adults (Phase 1, University of Wisconsin, Madison, completed) — The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants.…
Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD) (Phase 2, Nathan Brashares Sackett, n=40, recruiting) — This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD).…
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study (Observational, Johns Hopkins University, n=82, completed) — One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence.…
The psychedelic renaissance has a new owner: big pharma (News, FDA, active) — The Trump executive order granted FDA priority vouchers to three psychedelic programs—Compass Pathways and Usona for synthetic psilocybin, and Transcend Therapeutics for methylone—signaling a shift toward pharmaceutical development of psychedelics, while leaving religious and community uses untouched.
Psychedelics Research and Psilocybin Therapy (News, Johns Hopkins Center for Psychedelic and Consciousness Research) — Johns Hopkins has led psilocybin research, demonstrating safety and therapeutic potential in anxiety and smoking cessation, and has obtained regulatory approval to resume research with healthy volunteers.
Psychedelic Science @ Cornell (News, Cornell University) — Phase II trials of psilocybin‑assisted psychotherapy have shown efficacy in treating major depression, with durable reductions in symptoms after one or two dosing sessions.
The Neurobiological Effect of 5-HT2AR Modulation (Phase 1, Gitte Moos Knudsen, n=200, recruiting) — The investigators wish to investigate neurobiological effects of serotonin 2A receptor modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an antagonist (ketanserin).…
PsilOCD: A Pharmacological-Challenge Feasibility Study (Phase 1, Imperial College London, n=19, completed) — The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD).
Sustained Effects of Low-to-Moderate Doses of Psilocybin on Brain Connectivity (Preprint) — BackgroundPsilocybin is a classic psychedelic that acutely alters brain functional connectivity. These changes are linked to therapeutic doses and subjective effects, with some evidence that changes persist beyond acute drug administration.…
Psilocybin-facilitated Treatment for Cocaine Use (News, University of Alabama at Birmingham) — The FDA has identified potential noncompliance related to the clinical trial titled "Psilocybin-facilitated Treatment for Cocaine Use" because results information appears to have not been submitted to the ClinicalTrials.gov data bank. The responsible party is urged to review records and submit any required results information promptly.
COMP360 psilocybin treatment in TRD (Phase 2, Compass Pathways, n=233) — A single 25mg dose of COMP360 psilocybin, with psychological support, showed a statistically significant reduction in depressive symptoms after three weeks, with a durable response up to 12 weeks.
Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile (Phase 3, Compass Pathways plc, n=600, active) — The second Phase 3 trial (COMP006) for COMP360 (synthetic psilocybin) in treatment-resistant depression (TRD) showed that 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS score by week 6 and maintained it through week 26. The data confirms a rapid onset and durable profile, with a generally well-tolerated safety profile.
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.
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.
MDMA
MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD (Phase 3, Dr. Leslie Morland, n=16, completed) — The goal of this pilot trial is to examine the preliminary effectiveness of MDMA-facilitated bCBCT for improving chronic PTSD and relationship functioning in a sample of veterans and their intimate partners seeking care within the VA San Diego Healthcare System.
In Brief: ICER Issues Final Evidence Report and Recommendations Re: MDMA-Assisted Therapy; Lykos Responds (News, Institute for Clinical and Economic Review) — ICER’s final evidence report concluded that current data are insufficient to demonstrate a net health benefit of MDMA‑assisted therapy for PTSD, and it could not provide a price benchmark, while recommending a robust REMS program and oversight by independent societies. The report also urged that any approval be accompanied by comprehensive risk mitigation and provider certification.
MDMA Trials for PTSD in Soldiers: What to Know Now (Phase 3, Veterans Affairs (VA), active) — Phase 3 trial data reviewed by the FDA show significant reductions in symptom severity for treatment‑resistant PTSD; trials are ongoing and FDA approval is pending.
MDMA PTSD FDA Decision 2026 (Regulatory, FDA, approved) — The FDA approved MDMA‑assisted therapy for PTSD in 2026.
Drug Effects on Interpersonal Interaction (Observational, University of Chicago, n=30, completed) — The investigators propose to use a Paired Partner design, in which subjects engage in a 45-min semi-structured conversation with one (novel) partner under the influence of MDMA and with another partner under the influence of placebo.…
Effect of Stimulant Drugs on Social Perception (Phase 1, University of Chicago, n=36, completed) — The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.
BREAKING: FDA Publishes Lykos Therapeutics’ MDMA Complete Response Letter (CRL) (Regulatory, Lykos Therapeutics, approved) — The FDA issued a Complete Response Letter (CRL) to Lykos Therapeutics, rejecting their MDMA for PTSD application due to issues with adverse event reporting, lack of durability data, and potential selection bias. The FDA suggested a new clinical trial to address these concerns.
Jupiter Neurosciences enters the psychedelic space with $100 million MDMA deal (News, Jupiter Neurosciences) — Jupiter Neurosciences has entered the psychedelic drug development space by acquiring exclusive rights to MDMA-based treatments for PTSD from a private company. The deal is valued at up to $100 million.
Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation (Observational, University of California, San Diego, n=56, recruiting) — The purpose of this study is to examine the effects of combined intranasal esketamine with brief cognitive behavioral therapy for suicide prevention (BCBT-SP) for suicidal ideation (SI) in patients with treatment- resistant depression (TRD).…
Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation (Phase 3, University of Ottawa, n=20, active) — Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI.…
ED Treatment of Suicidal Patients With Ketamine Infusion (Phase 2, University of California, Davis, completed) — This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.
Observational Study of Ketamine Infusions for the Treatment of Chronic Pain (Observational, Theresa Lii, n=100, recruiting) — This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.
Naturalistic Study of Ketamine in the Treatment of Depression (Observational, Hospital de Clinicas de Porto Alegre, n=90, active) — This study aims to examine the effect of ketamine in decreasing the risk of suicide in patients with depression and its effectiveness as an antidepressant agent.
KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study (Phase 1, Helsinki University Central Hospital, n=12, recruiting) — Ketamine is a dissociative anesthetic developed approximately 60 years ago. Both ketamine and its isomer, esketamine, have been used for over 20 years in the treatment of treatment-resistant depression.…
Enhancing Week-long Psychological Treatment for PTSD With Ketamine (Phase 2, Yale University, n=162, recruiting) — The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD).…
Lidocaine-Ketamine for Management of Chronic Pain (Observational, Hamilton Health Sciences Corporation, n=72, active) — Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage".…
Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC (Observational, Centre Leon Berard, n=81, completed) — The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication).…
A Study to Decrease Suicidal Thinking Using Ketamine (Phase 3, United States Naval Medical Center, San Diego, completed) — Depression treatment typically is slow acting. Patients presenting with acute suicidality have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now widely tested as a rapid-acting treatment for depression.…
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD) (Phase 2, Icahn School of Medicine at Mount Sinai, n=30, completed) — The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment.…
Treatment of Suicidal Ideation With Intravenous Ketamine Infusion (Observational, University of Alabama at Birmingham, n=18, completed) — This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.
Ketamine for Opioid Use Disorder (Phase 2, University of Maryland, Baltimore, n=50, recruiting) — The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are: * Does ketamine reduce craving for opioids in patients with opioid use disorder?…
Ketamine for Depression and Alcohol Dependence (Phase 1, Yale University, n=5, completed) — The purpose of this study is to evaluate the efficacy of ketamine in reducing depressive symptoms in subjects with a comorbid major depressive episode and alcohol dependence.…
Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine (Observational, King's College London, n=27, completed) — The overarching aim of this research is to determine the acute effects of ketamine on brain glutamate, functional connectivity and cerebral blood flow in treatment-resistant depression, explore whether the effects are attenuated by the opioid receptor antagonist naltrexone and relate these findings to antidepressant response.
Intranasal Ketamine for Suicidal Ideation in Veterans (Observational, Bronx Veterans Medical Research Foundation, Inc, completed) — The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.
Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (Phase 1, Wayne Goodman MD, n=3, completed) — Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem.…
Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine (Observational, Psych Atlanta, n=10, completed) — This study aims to assess the efficacy and safety of intranasal esketamine as maintenance antidepressant therapy in patients who have demonstrated clinical improvement with off-label intravenous racemic ketamine for treatment-resistant depression.
Oral Ketamine for Control of Chronic Pain in Children (Phase 1, University of Rochester, n=12, completed) — The study is a maximum tolerated dose finding study for oral, chronic, daily administration of oral ketamine (by mouth) in children with long-term daily pain.
ASAM 2026: Ketamine Shows Potential as Dual-Target Treatment for Comorbid MDD and AUD (News) — The systematic review of 8 studies found that ketamine reduced relapse rates in 44% of studies, lowered depression scores in 77% of studies, and decreased alcohol cravings in 67% of studies, with sustained antidepressant effects lasting at least 4 weeks in participants with a family history of AUD.
Drug combo is the first to prolong ketamine’s antisuicide effects (News, Stanford Medicine, n=45, completed) — In a placebo‑controlled trial of 45 patients with major depressive disorder and suicidal ideation, low‑dose buprenorphine given daily for four weeks after a ketamine infusion extended the drug’s antisuicide effects. 78% of the buprenorphine group remained responsive after one month versus 48% of the placebo group, with greater reductions in suicidality scores.
Ketamine's promise for severe depression grows, major questions remain (News, Michigan Medicine) — The article reports that ketamine shows promise in treating severe depression, but more research is needed to address questions about long‑term efficacy, safety, and optimal dosing.
Racing Beyond Racemic: A Look at Ketamine Drug Development Ahead of atai’s PCN-101 Phase 2a Readout (Phase 2, Perception Neuroscience (part of the atai platform), active) — The article discusses the development of PCN-101 (R-ketamine or arketamine) by Perception Neuroscience for treatment-resistant depression, ahead of its Phase 2a data readout. It also provides background on ketamine and its enantiomers, S-ketamine (Spravato) and R-ketamine.
LSD
Mood Effects of Serotonin Agonists: Depression (Observational, University of Chicago, n=41, completed) — This study will examine the effect of a low dose of the 5HT2A agonist LSD (26 µg), compared to placebo, on acute and protracted mood states in individuals with depression. The investigators will assess the relationship between mood-related symptoms and EEG as a neurophysiological marker.
Drug Effects on Mood and Behavior - Expectancy (Observational, University of Chicago, n=42, completed) — This study will examine the effects of a single low dose of the 5HT2A agonist LSD (Lysergic Acid Diethylamide) (13 µg) or placebo in individuals who are or are not explicitly told what drug they will receive.…
'Wired For Worry': LSD Pharma Firm Launches Therapist-Targeted Education Campaign (News, Definium Therapeutics) — Definium Therapeutics has launched an unbranded educational campaign called 'Wired for Worry' targeting mental healthcare providers. The campaign aims to educate them about Generalized Anxiety Disorder (GAD) and its potential neurobiological underpinnings, as Definium develops an LSD variation (DT120) for treating GAD and major depression.
Neural Effects of Intravenous N,N-dimethyltryptamine (DMT) (Phase 1, Jon Dean, n=20, recruiting) — This study examines how the psychedelic substance DMT affects the human brain when administered by the intravenous (IV) route. DMT is a naturally occurring chemical in the body that is thought to help improve mood when ingested in a continuously monitored medical setting.…
How the ancestral toad medicine 5-MeO-DMT was manufactured (News) — The article discusses the historical synthesis and traditional use of 5‑MeO‑DMT, noting its brief psychedelic effects and its emerging interest as a potential rapid‑acting treatment for depression by companies such as Beckley PsyTech (now AtaiBeckley).
Clinical Study of GH001 in Depression (Phase 1, GH Research Ireland Limited, n=16, completed) — The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).…
Pharmacokinetics of GH001 in Healthy Volunteers (Phase 1, GH Research Ireland Limited, n=46, completed) — The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001.…
Trifecta Research Study (Observational, Axial Therapeutic Research, n=52, active) — This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.
Trifecta Research Study (Phase 2, Johns Hopkins University, completed) — The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning.…
ibogaine investigators brochure (News, MAPS) — MAPS released the first open‑access Ibogaine Investigator’s Brochure, compiling preclinical, safety, dosing, and observational data to support research and regulatory efforts.
Trump’s Executive Order Gives Psychedelic Therapy a Boost (News, White House) — The Trump executive order encourages psychedelic research, especially ibogaine, and allocates $50 million for state‑run research, but experts warn that evidence gaps and safety concerns remain.
One of the oldest psychedelics meets modern brain imaging (News, Northeastern University) — New research suggests mescaline may contribute to hallucinations and changes in sensory perception similar to those reported in some psychiatric conditions. Comparing mescaline to other psychedelics like LSD and psilocybin could help pinpoint the neural pathways causing specific hallucinogenic experiences.
2026 Second Quarter Policy & Advocacy Wrap-up (News, MAPS) — MAPS partnered with Colorado and Ohio to deliver free statewide psychedelic crisis assessment and intervention training for first responders, becoming the first state to license the program and expanding training to behavioral health, law enforcement, and EMS professionals.
MAPS Statement on Bipartisan Congressional Letter to FDA (News, MAPS) — The statement endorses a bipartisan congressional letter urging the FDA to expedite evaluation of MDMA‑assisted therapy for PTSD, calling for clearer guidance on the Special Protocol Assessment process and the integration of psychotherapy.
Exploring the Mental Health Needs of System – Impacted People (Meta-analysis, MAPS) — The literature review found that people directly impacted by the criminal legal system have a high prevalence of trauma, substance use disorders, and other complex mental health diagnoses, and that psychedelic‑assisted healing may be a potential tool to address these concerns, though significant obstacles remain.
Psychedelics and Censorship on Social Media (News, Chacruna Latinoamérica) — Chacruna Latinoamérica's Instagram account was permanently deactivated by Meta in 2026 after an opaque appeal process.
Evaluating the Pros and Cons of State Psychedelic Task Forces (Regulatory, John A. Burns School of Medicine at the University of Hawaii, active) — The Hawaii House Health Committee advanced a bill to establish a Mental Health Emerging Therapies Task Force, which will review scientific literature and develop policy recommendations for the safe, ethical implementation of psychedelic therapies such as psilocybin and MDMA.
A Trial of GH001 in Patients With Treatment-resistant Depression (Phase 2, GH Research Ireland Limited, n=81, completed) — The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin \[5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT\]) in patients with treatment-resistant depression (TRD).…
Midomafetamine Capsules (NDA 215455) (Regulatory, FDA, approved) — Two short-term studies showed clinically meaningful improvement in PTSD symptoms with midomafetamine. A long-term follow-up suggested durable effects, but interpretability is impacted by functional unblinding, dropout rates, and other factors. The contribution of psychotherapy and the safety profile, particularly abuse potential, require further characterization.
Federal Agencies Advance Psychedelic Therapy Following Trump’s Executive Order (Regulatory, Department of Veterans Affairs, active) — President Trump signed an Executive Order to accelerate psychedelic therapy research, allocating $50 million and directing agencies like the FDA, DEA, HHS, and VA to establish pathways for access and collaborate on research. The VA is involved in 20 active clinical trials for conditions like PTSD and depression.
Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover (News, Eli Lilly) — Eli Lilly is acquiring AtaiBeckley in a deal that marks the pharma's first foray into the emerging psychedelics field. The deal is valued at up to $3.8 billion, including an upfront payment and a contingent value right.