Psychedelic Clinical Trials
From BurnZero
Here is a list of all scheduled future clinical trials on psychedelics.
| Quarter Completing | Trial Title | Sponsor | Type | Phase |
|---|---|---|---|---|
| Q1 2023 | LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects | University Hospital, Basel | IIT | Phase 1 |
| Q1 2023 | IM and IV SPL026 Drug Product in Healthy Participants | Small Pharma | Commercially Sponsored | Phase 1 |
| Q1 2023 | Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder | Keith Heinzerling | IIT | Phase 2 |
| Q1 2023 | A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer | University of Utah | IIT | Phase 1 |
| Q1 2023 | The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study | Brain and Cognition Discovery Foundation | Commercially Affiliated | Phase 2 |
| Q1 2023 (H1 2023 Readout) | A study to assess Two formulations of VLS-01 (DMT) in healthy participants | Virida Life Sciences (atai Life Sciences) | Commercially Sponsored | Phase 1 |
| Q1 2023 | An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians | Edith Cowan University | IIT | Phase 1/2 |
| Q1 2023 | Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness (MDR) | University Hospital, Basel | IIT | Phase 1 |
| Q1 2023 (H2 2023 Readout) | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 (MDMA Derivative) in Healthy Adult Volunteers | EmpathBio (atai Life Sciences) | Commercially Sponsored | Phase 1 |
| Q1 2023 (H1 2023 Readout) | A Study of Psilocybin for Major Depressive Disorder (MDD) | Usona Institute | Commercially Sponsored | Phase 2 |
| Q1 2023 (Q1 2023 Readout) | A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of RE104 In Healthy Volunteers | Reunion Neuroscience | Commercially Sponsored | Phase 1 |
| Q2 2023 | The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. | Sheppard Pratt Health System | Commercially Affiliated | Phase 2 |
| Q2 2023 | Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder | Yale University | Commercially Affiliated | Phase 1 |
| Q2 2023 | A Single Ketamine Infusion Combined With Music for Suicidal Ideation During a Depressive Episode: A Randomized Open Label Clinical Trial | The University of Texas Health Science Center at Tyler | IIT | Phase 2 |
| Q2 2023 | SPL026 With or Without SSRIs in Participants With MDD | Small Pharma | Commercially Sponsored | Phase 1 |
| Q2 2023 | Effects of Psilocybin in Anorexia Nervosa | Johns Hopkins University | IIT | Phase 1 |
| Q2 2023 | Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study | Anders Fink-Jensen, MD, DMSci | IIT | Phase 2 |
| Q2 2023 | An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives | Janssen-Cilag, S.A. | IIT | Phase 3 |
| Q2 2023 | A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide | Janssen Research & Development, LLC | Commercially Sponsored | Phase 2 |
| Q2 2023 | Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion | Johns Hopkins University | IIT | Phase 1 |
| Q2 2023 | A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder | MAPS | Commercially Sponsored | Phase 3 |
| Q2 2023 | A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers | Bright Minds Biosciences | Commercially Sponsored | Phase 1 |
| Q2 2023 | Psilocybin for Treatment of Obsessive Compulsive Disorder | University of Arizona | IIT | Phase 1 |
| Q2 2023 | Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness | St. Vincent's Hospital Melbourne | Commercially Affiliated | Phase 2 |
| Q2 2023 | A pilot study testing the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters, inflammation marker levels, safety, and mood in healthy adult volunteers | Biochem Industries | Commercially Sponsored | N/A |
| Q2 2023 | A Treatment Development Study of MDMA-Assisted Psychotherapy for PTSD | Remedy | Commercially Sponsored | Phase 2 |
| Q2 2023 | Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification | International Center for Ethnobotanical Education, Research, and Service | Commercially Affiliated | Phase 2 |
| Q2 2023 | A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin | University of Wisconsin, Madison | Commercially Affiliated | Phase 1 |
| Q2 2023 | A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide | Seelos Therapeutics, Inc. | Commercially Sponsored | Phase 2 |
| Q2 2023 | Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders | Yale University | Commercially Affiliated | Phase 1 |
| Q2 2023 | Thorough QT/QTc (TQT) Clinical Trial to Evaluate the Effect of Psilocybin on Cardiac Repolarization in Healthy Volunteers | Usona Institute | Commercially Sponsored | Phase 1 |
| Q2 2023 | Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers | University of Wisconsin, Madison | IIT | Phase 1 |
| Q2 2023 | Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study | Joshua Woolley, MD/PhD | IIT | Phase 2 |
| Q2 2023 (H1 2023 Readout) | A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of Ascending Single and Fixed Repeat Intravenous Doses of DMT in Healthy Subjects | Algernon Pharmaceuticals | Commercially Sponsored | Phase 1 |
| Q2 2023 | Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users | Medical University of South Carolina | IIT | Phase 2 |
| Q3 2023 | Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function (MASM) | University of California, San Diego | IIT | Phase 1 |
| Q3 2023 | Behavioral and Neural Mechanisms Supporting Psilocybin-assisted Therapy for Phantom Limb Pain | University of California, San Diego | IIT | Phase 1 |
| Q3 2023 | Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II | Yale University | IIT | Phase 1 |
| Q3 2023 | ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression | Beckley Psytech | Commercially Sponsored | Phase 1/2 |
| Q3 2023 | Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study | University of Alabama at Birmingham | IIT | Phase 2 |
| Q3 2023 | An Observational Pre-post Study Evaluating the Safety of Tabernanthe Iboga Exposure | Stanford University | IIT | N/A |
| Q3 2023 | Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health | University of Alabama at Birmingham | Commercially Affiliated | N/A |
| Q3 2023 (H2 2023 Readout) | The Safety and Tolerability of COMP360 in Participants With Post-Traumatic Stress Disorder | COMPASS Pathways | Commercially Sponsored | Phase 2 |
| Q3 2023 | Microdosing Psychedelics to Improve Mood | Rotem Petranker | IIT | Phase 2 |
| Q3 2023 | Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample | University of Wisconsin, Madison | Commercially Affiliated | Phase 1 |
| Q3 2023 | The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC) | Emory University | IIT | Phase 1 |
| Q3 2023 | Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder | Halucenex Life Sciences Inc. | Commercially Sponsored | Phase 2 |
| Q3 2023 | Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study | University Hospital, Basel | IIT | Phase 1 |
| Q4 2023 (Q1 2023 Interim Readout) | A Study of a Psilocybin Analog (CYB003) in Health Participants With and Without Major Depressive Disorder | Cybin | Commercially Sponsored | Phase 1/2 |
| Q4 2023 | Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial | Monash University | Commercially Affiliated | Phase 2 |
| Q4 2023 | An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder | Beckley Psytech | Commercially Sponsored | Phase 2 |
| Q4 2023 (H2 2023 Readout) | An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 (5-MeO-DMT) in Patients With Treatment Resistant Depression | Beckley Psytech | Commercially Sponsored | Phase 2a |
| Q4 2023 | Psilocybin Treatment in Obsessive-Compulsive Disorder: a Preliminary Efficacy Study and Exploratory Investigation of Neural Correlates. | Yale University | IIT | Phase 1 |
| Q4 2023 | The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder | Maryland Oncology Hematology, PA | Commercially Affiliated | Phase 2 |
| Q4 2023 (H1 2023 Phase 1 Readout) | Ibogaine to Determine Maximum Tolerated Dose (MTD) or Treat-to-Target Dose (TTD) for the Evaluation of Efficacy and Safety | DemeRx IB, Inc. (atai Life Sciences) | Commercially Sponsored | Phase 1/2 |
| Q4 2023 | An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) | Sheppard Pratt Health System | Commercially Affiliated | Phase 2 |
| Q4 2023 | A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study | King's College London | IIT | Phase 2 |
| Q4 2023 | Psilocybin-assisted Interpersonal and Social Rhythm Therapy for Depression | University of Otago | IIT | N/A |
| Q4 2023 (H2 2023 Readout) | Safety and Efficacy of Repeated Low Dose MM-120 (LSD) as Treatment for Attention Deficit Disorder (ADHD) in Adults | MindMed | Commercially Sponsored | Phase 2 |
| Q4 2023 | Neural and Physiological Correlates of Psychedelic Sub-states (i2) | Robin Carhart-Harris, PhD, MA | IIT | Phase 2 |
| Q4 2023 (H2 2023 Readout) | A Dose-Finding Study of MM-120 (LSD) for the Treatment of Anxiety Symptoms | MindMed | Commercially Sponsored | Phase 2 |
| Q4 2023 | Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD) | Cybin Therapeutics Inc. | Commercially Sponsored | Phase 2 |
| Q4 2023 | An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder | University of California, San Francisco | IIT | Phase 2 |
| Q4 2023 | Investigating the impact of of Psilocybin and guided meditation on brain connectivity in healthy adults | Monash University | IIT | Phase 1 |
| Q4 2023 | A Retrospective Study Determine the Impact of Psychedelic Therapy for Dimensional Measures of Wellness | Canadian Forces Health Services Centre Ottawa | IIT | N/A |
| Q4 2023 | Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study | Johns Hopkins University | Commercially Affiliated | N/A |
| Q4 2023 | Safety and Efficacy of Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache: a Randomized, Double-blind, Placebo-controlled Phase II Study | University Hospital, Basel | Commercially Affiliated | Phase 2 |
| Q4 2023 | Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on Buprenorphine/Naloxone | University of Wisconsin, Madison | Commercially Affiliated | Phase 1 |
| Q4 2023 | Open-label Phase 2 Study of MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD | VA Loma Linda Health Care System | Commercially Affiliated | Phase 2 |
| Q4 2023 | Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase | University of Wisconsin, Madison | Commercially Affiliated | Phase 1 |
| Q4 2023 | Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects ("MELO"): A Blinded, Placebo-Controlled, Dose-Finding Study | Optimi Health Corporation | Commercially Sponsored | Phase 1 |
| Q4 2023 | Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I | Yale University | IIT | Phase 1 |
| Q4 2023 (H2 2023 Readout) | Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study | COMPASS Pathways | Commercially Sponsored | Phase 2 |
| Q4 2023 | Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease | Johns Hopkins University | IIT | Phase 1 |
| Q4 2023 | A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout | University of Washington | IIT | Phase 1/2 |
| Q4 2023 | Effects of MDMA-like Substances in Healthy Subjects (MDMA-like) | University Hospital, Basel | IIT | Phase 1 |
| Q4 2023 | Acute Effects of R- and S-MDMA in Healthy Subjects (R-S-MDMA) | University Hospital, Basel | Commercially Affiliated | Phase 1 |
| Q4 2023 | Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder | University of Zurich | IIT | Phase 2 |
| Q4 2023 | An open-label study of the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD) | Swinburne University of Technology | IIT | Phase 2 |
| (Q4 2023 Readout) | APEX-52 (Psilocybin) for the treatment for depression, anxiety, and PTSD with the Veteran community | Apex Labs | Commercially Sponsored | Phase 2b |
| (H2 2023 Interim Readout) | Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD) | Clairvoyant Therapeutics | Commercially Sponsored | Phase 2 |
Trials Completed in 2022 Yet to Publish Results
Below is a smaller table of psychedelic trials that completed in 2022, but are yet to publish results. We might expect to see topline results from some of these trials soon.
| Quarter Completing | Trial Title | Sponsor | Type | Phase |
|---|---|---|---|---|
| Q4 2022 | A Phase 1, Single Center, Open Label, Randomized Sequence, 2-period Cross-over Study to Determine the Effect of Food on the Relative Bioavailability of 3,4-methylenedioxymethamphetamine (MDMA) Oral Formulation in Healthy Volunteers | MAPS | Commercially Sponsored | Phase 1 |
| Q4 2022 | LSD Therapy for Persons Suffering From Major Depression (LAD) | MAPS | Commercially Sponsored | Phase 2 |
| Q4 2022 (H1 2023 Readout) | A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity | MAPS | Commercially Sponsored | Phase 3 |
| Q4 2022 | Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder | New York State Psychiatric Institute | Commercially Affiliated | Phase 2 |
| Q4 2022 | Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG | Entheon Biomedical | Commercially Sponsored | N/A |
| Q4 2022 (2023 Readout) | A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study | Clexio Biosciences | Commercially Sponsored | Phase 2 |
| Q3 2022 | Effects of Dimethyltryptamine (DMT) in Healthy Subjects: A Placebo-controlled Cross-over Study | University Hospital, Basel | Commercially Affiliated | Phase 1 |
| Q3 2022 | A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers | MAPS | Commercially Sponsored | Phase 1 |
| Q3 2022 | Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects | University Hospital, Basel | Commercially Affiliated | Phase 1 |