Psychedelic Clinical Trials

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