Psilocybin Therapy for Methamphetamine Use Disorder and HIV (Phase 2, Nicky Mehtani, MD, MPH, n=30, recruiting) — 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.…
Psilocybin With Intracranial Neural Sensing (Phase 1, Joshua Woolley, MD, PhD, n=20, recruiting) — This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices.…
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder (Phase 2, Psyence Australia Pty Ltd, n=87, recruiting) — This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for?…
The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density (Phase 2, Section for Affective Disorders; Northern Stockholm Psychiatry, n=35, completed) — PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms Psykiatri Vårdvägen 3 112 19 Stockholm Sweden Medical Monitor Inspira Medical AB Phase of Study Phase 2b Sample Size 30 randomized Name of Investigational Product (IP) Psilocybin, 3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate Name of Active Placebo Niacin EudraCT 2020-002790-94 Description of IP and Active Placebo PSIPET Protocol 5 200821 Page 14 Study Intervention Name: Psilocybin (active drug product) Niacin (active placebo product) Dosage formulation: One active capsule contains 25 mg of psilocybin One active placebo capsule contains 100 mg of niacin Capsule: Size 2 hydroxypropyl methylcellulose (HPMC), opaque Size 2 HPMC, opaque Unit dose strength: 25 mg 100 mg Route of Administration: Oral (solid dose) Oral (solid dose) Dosing instructions: One capsule administered with water One capsule administered with water Packaging and Labeling: Study Intervention will be provided in a high-density polyethylene (HDPE) bottle.…
Psychopharmacology of Psilocybin in Cancer Patients (Phase 2, Johns Hopkins University, n=56, completed) — This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND) (Phase 2, Centre for Addiction and Mental Health, n=16, recruiting) — Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.…
’Shrooms Lead the Pack in Psychedelic Medicine, but Rollout Is Bumpy (News, Compass Pathways) — Psilocybin-assisted therapy is legal in three states, but access has so far been limited and expensive. The FDA is moving up its review of a psilocybin treatment for severe depression.
MDMA
MDMA-AT for PTSD in Young Adults With Childhood Trauma (Phase 2, Jenna M. Traynor, n=15, recruiting) — This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).…
MAPS Responds to Report of Progress for MDMA-Assisted Therapy for PTSD with FDA (Regulatory, MAPS, active) — MAPS is responding to a report that Resilient Pharmaceuticals has resubmitted its new drug application for MDMA-assisted therapy for PTSD to the FDA, following a Complete Response Letter in August 2024. The resubmission occurs without a new Phase 3 study, and the FDA has recently issued new guidance on psychedelic drug investigations.
Two Years After Rejection, Resilient Quietly Refiles MDMA for PTSD Application (Regulatory, Resilient Pharmaceuticals, active) — Resilient Pharmaceuticals has resubmitted its MDMA for PTSD new drug application (NDA) to the FDA, nearly two years after its initial rejection. The resubmission includes data from third-party studies and a new Phase I safety trial, addressing FDA's previous concerns about adverse events, durability, and participant screening.
The application of esketamine in cancer-related depressive states: attention from mechanisms to clinical translation. (Phase 2) — This article reviews the clinical status and treatment challenges of cancer-related depressive states, clarifies the mechanism of action of esketamine-a novel rapid-acting antidepressant-compares its efficacy with traditional drugs, evaluates safety and tolerability, and summarizes clinical evidence to support clinical practice and research.…
CAP-Ketamine for Antidepressant Resistant PTSD (Phase 2, VA Office of Research and Development, n=163, completed) — The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression (Phase 2, The University of Texas Health Science Center, Houston, n=1, completed) — Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period.…
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement (Phase 2, University of California, San Diego, n=88, recruiting) — The goal of this clinical trial is to examine the usefulness of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) for individuals with opioid use disorder who are receiving medication treatment.…
An Open Prospective Trial of IV Ketamine in Suicidal Adolescents (Phase 2, Nationwide Children's Hospital, n=10, active) — 1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents with suicidal ideation and depression. It is hypothesize that Ketamine will be well tolerated and significantly reduce depressive symptoms and suicidal ideation. 2.…
Glutamatergic Modulation of Cocaine-related Deficits (Phase 2, New York State Psychiatric Institute, n=8, completed) — Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits.…
Imaging SV2A in Mood Disorders (Observational, Yale University, n=130, active) — This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects.…
Sustained Ketamine Effectiveness for Suicidal Ideation (Observational, University Hospital, Montpellier, n=128, completed) — As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated.…
Trial of Ketamine and Lithium Therapy in Bipolar Depression (Phase 2, Yale University, completed) — This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them.
Esketamine on Postpartum Depression in Cesarean Section Women (Observational, Ailin Luo, n=336, completed) — This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug
LSD therapy: A few hundred meters from where it began. (Phase 2) — In Basel, only a few hundred meters from where LSD was first synthesized, we tested LSD-assisted therapy for major depression in a randomized trial comparing two high doses with two low doses, each paired with supportive psychotherapy.…
The impact of fluoxetine on the aversive effects of lysergic acid diethylamide. (Phase 2) — Serotonergic antidepressant history can reduce the subjective effects, including therapeutic efficacy, of a number of psychedelics. A related issue is the impact of traditional antidepressants with serotonergic action on the adverse effects of psychedelics. Becker et al.…
DMT
SPL026 With or Without SSRIs in Participants With MDD (Phase 1, Small Pharma Ltd, n=18, completed) — The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.
Trump signs order to fast track psychedelic drug research to treat veterans with PTSD (Regulatory, Centers for Medicare & Medicaid Services, approved) — President Trump signed an executive order to expedite research into ibogaine for treating PTSD and traumatic brain injuries in veterans, removing legal restrictions and establishing FDA protocols for its safe therapeutic use.
Correlates of Anxiety Associated With a Life-threatening Illness (Observational, Resilient Pharmaceuticals, n=12, completed) — The goal of this observational trial is to gather brain scan data on people undergoing MDMA-assisted therapy. The main question it aims to answer is: -How does brain activity change while completing an emotional regulation task in participants receiving MDMA-assisted therapy?…
MRI Studies of Emotion in Depression (Observational, Icahn School of Medicine at Mount Sinai, n=135, completed) — The purpose of this study is to research the effects of ketamine on brain function in patients with Major Depressive Disorder (MDD). This study is an ancillary MRI neuroimaging study being conducted in patients with MDD who are enrolled in a separate clinical trial.…
Study of NMDA Antagonists and Neuropathic Pain (Phase 2, University Hospital, Clermont-Ferrand, n=7, completed) — The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.…
Opiate Suicide Study in Patients With Major Depression (Phase 3, Stanford University, n=50, completed) — To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete.…
Plant Medicine Influencer Culture on Social Media (News) — The article discusses the rise of social media influencers in the plant medicine space, coinciding with increased public interest in psychedelics and renewed clinical research. It highlights how social media has democratized access to information but also risks decontextualizing and commodifying ancient knowledge and psychedelic experiences.
AOC, Other Members of Congress Tout Psychedelic Benefits as Research Amendments Advance (News, Department of Defense, active) — Bipartisan lawmakers are leveraging the National Defense Authorization Act to extend military clinical trials for substances like psilocybin and MDMA. The Department of Veterans Affairs is also pushing to expedite treatment research for PTSD. A Louisiana law uses opioid settlement funds for a pilot program targeting substance abuse and treatment-resistant mental health conditions.
Trump Signs Executive Order Endorsing Psychedelic Psilocybin and Ibogaine; Asks 'Can I Have Some, Please?' (Regulatory, approved) — President Trump signed an executive order directing federal agencies to expedite the review and funding of psychedelic drugs, including psilocybin and ibogaine, for serious mental illness treatments. The order allocates $50 million for state-level research programs and instructs the FDA to issue National Priority Vouchers for qualifying psychedelic compounds.