Psychedelic Trials

A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients
This Phase I interventional study (n=64) focuses on assessing the feasibility of a resilience-focused community of practice program that incorporates psilocybin-assisted therapy for patients experiencing end-of-life distress.
Status: Not yet recruiting
Start date: 2023-09-01
Phase I
Open
64 participants
Interventional
LSD Occupancy of the Serotonin 2A Receptor in the Human Brain (dOccLS)
This early-phase, interventional trial (n=40) investigates LSD occupancy at the serotonin 2A receptor (5-HT2AR) in the human brain. Healthy participants aged 18-75 will receive a single dose of LSD ranging from 25 to 200 micrograms equivalent freebase.
Status: Recruiting
Start date: 2023-11-08
Phase I
Open
40 participants
Interventional
A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE II)
This double-blind, randomized, placebo-controlled trial (n=226) aimed to assess the efficacy and safety of intranasal esketamine 84 milligrams (mg) in addition to comprehensive standard care for rapidly reducing Major Depressive Disorder (MDD) symptoms, including suicidal ideation, in adults at imminent risk for suicide.
Status: Completed
Start date: 2017-06-15
Phase III
Blinded
230 participants
Interventional
A Dose-Ranging Study of 50 µg to 100 µg LSD in Healthy Volunteers
This Phase I study explored the safety, tolerability, pharmacokinetics, and pharmacodynamics of low doses of Lysergic Acid Diethylamide (LSD) ranging from 50 µg to 100 µg.
Status: Completed
Start date: 2015-10-20
Phase I
Open
32 participants
Interventional
Psilocybin as a model of psychotic illness
This phase I human pharmacology trial (n=40), sponsored by the National Institute of Mental Health in the Czech Republic, investigates the effects of psilocybin on brain connectivity in a pharmacological model of psychosis.
Status: Active, not recruiting
Start date: 2014-01-01
Phase I
Blinded
40 participants
Interventional
Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure
This observational cohort study (n=30) evaluated the safety and efficacy of Ibogaine-Magnesium Therapy in veterans with sequelae of repeated blast exposure.
Status: Completed
Start date: 2021-11-15
Not Applicable
Open
30 participants
Observational
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/​Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)
This Phase III interventional trial (n=676) will evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants with treatment-resistant major depressive disorder (MDD) experiencing a moderate to severe depressive episode.
Status: Completed
Start date: 2020-08-21
Phase III
Open
676 participants
Interventional
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (BIPOD-In)
This double-blind, controlled trial (n=90) 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 standard-of-care buprenorphine treatment for opioid use disorder (OUD).
Status: Recruiting
Start date: 2023-12-01
Phase II
Blinded
90 participants
Interventional
Drug Effects on Interpersonal Interaction
This double-blind, placebo-controlled crossover trial (n=30) investigated the effects of MDMA (100mg) compared to placebo on feelings of closeness and mood in semi-structured dyadic conversations.
Status: Completed
Start date: 2021-08-01
Phase I
Blinded
30 participants
Interventional
MDMA for AUD/​PTSD Comorbidity (MDMA)
This open-label, phase 2 trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
Status: Not yet recruiting
Start date: 2023-09-01
Phase II
Open
18 participants
Interventional
A randomised, double-blind, placebo-controlled trial to study the effects of repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain activity in healthy adult males
This randomized, double-blind, placebo-controlled trial (n=80) will study the effects of repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain activity in healthy adult males. Participants will receive either 10 µg of LSD or a placebo, dissolved in water in 1 ml oral syringes, taken once every three days for a total of 14 doses over a 41-day regimen.
Status: Completed
Start date: 2019-11-19
Phase I
Blinded
80 participants
Interventional
A dose-finding and proof-of-concept study of the efficacy and safety of MSP-1014.OX in patients with major depressive disorder
This adaptive-design, phase IIa/IIb trial (n=70) aims to assess the safety, cardiovascular effects, pharmacokinetics, and pharmacodynamic profile of MSP-1014.OX (psilocin pro-drug) in patients with major depressive disorder (MDD) who have not responded adequately to SSRIs.
Status: Recruiting
Start date: 2023-06-28
Phase I
Blinded
70 participants
Interventional
Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD)
This interventional trial (n=60) will assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP/PAT) involving family members in adults with treatment-resistant major depressive disorder (TRMDD). The study will compare two groups, one where PAT involves family members and another where PAT is conducted solely with therapists.
Status: Not yet recruiting
Start date: 2023-09-04
Phase I
Open
60 participants
Interventional
Lysergic Acid Diethylamide (LSD) in Palliative Care (LPC)
This randomized, double-blind, active-placebo controlled trial (n=60) will evaluate the effects of LSD on psychosocial distress in patients suffering from an end-stage fatal disease with a life expectancy of 12 weeks to 2 years.
Status: Not yet recruiting
Start date: 2023-09-01
Phase II
Blinded
60 participants
Interventional
Delix Therapeutics Phase I Trial for Novel Compound DLX-001
This Phase I clinical trial (n=100) will assess the safety, pharmacokinetics, psychometric functions, and markers of brain activity and synaptic plasticity of DLX-001, a non-hallucinogenic psychoplastogen developed by Delix Therapeutics.
Status: Planned
Start date: 2023-05-19
Phase I
Open
100 participants
Interventional
Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
This phase I/II trial (n=56) will study the safety and side effects of psilocybin in combination with therapy for treating cancer-related anxiety in patients with metastatic cancer. Psilocybin is being studied to treat anxiety or depression in patients with advanced cancer. Participants will receive psilocybin orally and participate in group and individual therapy sessions.
Status: Not yet recruiting
Start date: 2023-09-01
Phase I
Blinded
56 participants
Interventional
2C-B vs psilocybin Maastricht Study
This trial is registered with the Dutch trial registry that has been offline for over a year and hasn't been registered in any other database. We will update this record once it becomes available. All data are estimates.
Status: Completed
Start date: 2022-01-01
Not Applicable
Open
22 participants
Interventional
Phase I psilocybin safety trial ATMA
This Phase I open-label trial (n=14) studied the safety of psilocybin when administered to healthy participants enrolled in a psychedelic-assisted therapy training program. Participants ingested 25 mg of psilocybin extract, and vital signs, including heart rate, blood pressure, temperature, and ECG, were monitored throughout the study.
Status: Completed
Start date: 2021-10-01
Phase I
Open
14 participants
Interventional
Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
This open-label, single-arm Phase II clinical trial (n=15) will study the effects of GH001 (5-MEO-DMT) on patients with bipolar II disorder experiencing a major depressive episode.
Status: Recruiting
Start date: 2023-04-06
Phase II
Open
15 participants
Interventional
MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
This randomized, interventional trial (n=30) will evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted therapy in the treatment of posttraumatic stress disorder (PTSD) in partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University.
Status: Not yet recruiting
Start date: 2023-09-01
Phase II
Open
30 participants
Interventional
LUCID-201-001: A Double-Blind, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Lucid-201
This double-blind, single-ascending dose trial (n=48) will assess the safety and tolerability of single ascending doses of orally administered Lucid-201 in healthy participants and patients with symptoms of depression on stable doses of SSRI or SNRI medications.
Status: Not yet recruiting
Start date: 2023-03-15
Phase I
Blinded
48 participants
Interventional
An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome
This open-label trial (n=10) will examine low-dose psilocybin as a safe treatment alternative for Fragile X Syndrome (FXS), aiming to improve markers of cognition, communication, mood, behaviour, neuroinflammation, serotonin levels in exosomes, and neuroplasticity.
Status: Recruiting
Start date: 2023-03-28
Phase II
Open
10 participants
Interventional
Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects (DHTP)
This clinical trial (n=16) aims to compare the pharmacokinetic and pharmacodynamic profiles of DMT and Harmine and their safety and tolerability through six study days with varying doses. Participants will be closely monitored for adverse events and receive continuous psychological support in a controlled environment.
Status: Not yet recruiting
Start date: 2023-05-01
Phase I
Blinded
16 participants
Interventional
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
This Phase III trial (n=252) investigated the effect of esketamine (58-84mg, 8x) on treatment-resistant depression (TRD). Ultimately the trial didn't find significant results at 28 days.
Status: Completed
Start date: 2018-02-15
Phase III
Blinded
252 participants
Interventional
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
This randomized, double-blind, single-site phase II trial (n=40) will investigate MDMA-assisted therapy's safety and preliminary efficacy compared with low-dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity.
Status: Not yet recruiting
Start date: 2023-10-01
Phase II
Blinded
40 participants
Interventional
Mindfulness and Psychedelics
This double-blind, placebo-controlled trial (n=40) aims to investigate the potential neurophysiological synergy effects between mindfulness meditation and psychedelics, particularly Ayahuasca, on experienced meditators.
Status: Recruiting
Start date: 2023-02-20
Phase I
Blinded
40 participants
Interventional
Tolerability of MDMA in Schizophrenia (TMS)
This open-label trial (n=20) aims to investigate the tolerability of ± 3,4-methylenedioxymethamphetamine (MDMA) in patients with schizophrenia. Impaired social motivation is a negative symptom of schizophrenia that has no effective treatment, and MDMA has shown promise in increasing social motivation and bonding in healthy individuals and other psychiatric conditions such as PTSD.
Status: Not yet recruiting
Start date: 2023-03-15
Phase I
Open
20 participants
Interventional
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
This trial (n=64) aims to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers. The study design is a double-blind, placebo-controlled, randomized design with single, injected doses of GH002 and an open-label, non-randomized study design with intra-subject dose-escalation of GH002.
Status: Planned
Start date: 2023-03-01
Phase I
Blinded
64 participants
Interventional
Abuse Potential and Human Pharmacology of Methylone
This trial (n=17) aimed to assess the abuse potential, subjective and physiological effects, pharmacokinetic parameters, and metabolism of methylone (200mg), a synthetic cathinone popularized as an alternative to illegal psychostimulants such as MDMA (100mg) and mephedrone.
Status: Completed
Start date: 2021-12-01
Phase I
Open
17 participants
Interventional
Neural and Physiological Correlates of Psychedelic Sub-states (i2)
This open-label trial (n=12) will test repeated doses of psilocybin (first 10mg, then 3x 25mg; at least 7 days apart) and employ MRI scans to discover reliable brand and body reactions during the psychedelic experience. Specific to this study is that every 100 seconds participants will be asked about their rating (valence) of the experience.
Status: Not yet recruiting
Start date: 2023-02-01
Open
12 participants
Interventional

Find Psychedelic Trials

Browse through all psychedelic trials that have been done or are ongoing. These trials, usually double-blind, placebo-controlled studies, are the core of psychedelic research. The outcome of these trials will determine the future of psychedelics as medicine.

The trials included in our database come from ClinicalTrials.Gov and from the various companies pursuing psychedelics as medicine. Most of the trials have been funded by universities, though companies and governments are currently starting to ramp up their involvement.