Psychedelic Trials

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
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscular (IM) in varying doses from placebo to 16mg. Half of the cohorts (each with 5 getting 5-MeO, 1 placebo) will receive multiples doses (e.g. 2.5mg followed 3 hours later by 4.5mg). The trial will provide valuable data on the pharmacokinetics and safety of 5-MeO-DMT in humans.
Status: Recruiting
Start date: 2022-12-27
Phase I
Blinded
54 participants
Interventional
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (DMT BDR)
This open-label trial (n=36) will test a variety of mixed (or escalation) doses of DMT (5-25mg) in healthy subjects. The study is unique in testing many different dosages within the same subject (versus between groups).
Status: Not yet recruiting
Start date: 2023-03-15
Phase I
Open
36 participants
Interventional
A Phase III Trial Investigating the Effects of Ketamine-Assisted Therapy in the Treatment of Alcohol Use Disorder
Awakn Life Sciences has announced a Phase III trial to explore the effects of ketamine-assisted therapy in the treatment of alcohol use disorder (AUD).
Status: Planned
Start date: 2023-05-01
Phase III
Blinded
280 participants
Interventional
Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI
This trial (n=20) investigates the effects of psilocybin (18.2mg/70kg) on several brain measures and sleep quality.
Status: Completed
Start date: 2014-06-18
Phase I
Blinded
20 participants
Interventional
Effects of MDMA on memory when witnessing or committing a simulated crime
This trial (n=60) investigated the effect of MDMA (75mg) on the formation of memories. This was tested by simulating a crime (virtual reality). The trial found no significant effect of heightened vulnerability to external suggestions from MDMA.
Status: Completed
Start date: 2018-09-12
Phase I
Blinded
60 participants
Interventional
PET Synaptogenesis After Psilocybin In DEpression Recovery (PET-SPIDER)
This neuroimaging trial (n=24) investigates the effects of one high dose of psilocybin (25mg) in those with depression. It specifically investigates the synaptic density (synapses are the connections between brain cells; neurons). The aim is to assess the relationship between the antidepressant and neurotrophic (growth within brain) effects of psilocybin.
Status: Not yet recruiting
Start date: 2023-01-01
Phase II
Open
24 participants
Interventional
An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers
This small open-label trial (n=8) will test the safety of two doses of the ayahuasca brew containing DMT (1.0mg to 1.4mg/kg). The trial is sponsored by Psychae and is done in collaboration with St. Vincent's Hospital in Melbourne Australia.
Status: Not yet recruiting
Start date: 2022-11-05
Phase I
Open
8 participants
Interventional
A study in healthy volunteers to look at how COMP360 is taken up by the body when given as two different strength capsules
This open-label trial will assess the bioavailability of COMP360 (psilocybin) in healthy volunteers (n=14). The trial will assess the effects of both 5 and 25 mg doses of COMP360.
Status: Recruiting
Start date: 2022-06-16
Phase I
Open
14 participants
Interventional
A study on the safety and effects of the drug DMT in healthy smoking individuals
This double-blind placebo-controlled trial aims to assess the effects of DMT on healthy participants who smoke (n=50).
Status: Recruiting
Start date: 2021-01-08
Phase I
Blinded
50 participants
Interventional
Consciousness and Psilocybin Effects on Well-Being: Pilot Phase (CoPE Pilot)
This pilot study aims to establish a dosing regimen for intravenous (IV) psilocybin that will allow the drug to be administered to asleep participants without awakening them and assess whether this dosing regimen produces a psychedelic experience.
Status: Not yet recruiting
Start date: 2023-03-01
Phase I
Open
15 participants
Interventional
Psilocybin for depression
This open-label trial (n=12), also known as PSILODEP-PILOT is the first to test psilocybin in patients in the UK. The study found psilocybin (10-25mg, x2) to be well-tolerated.
Status: Completed
Start date: 2015-04-01
Phase II
Open
12 participants
Interventional
Psilocybin-assisted Interpersonal and Social Rhythm Therapy for Depression
This open-label trial (n=20) seeks to evaluate psilocybin-assisted interpersonal social and rhythm therapy (IPSRT) for treatment-resistant depression. Participants will receive two doses of psilocybin and eight sessions of psychotherapy.
Status: Not yet recruiting
Start date: 2022-11-15
Phase I
Open
20 participants
Interventional
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
This project tests the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of KUR-101 in 58 healthy participants.
Status: Recruiting
Start date: 2022-02-15
Phase I
Blinded
58 participants
Interventional
A Fixed Repeat Dose Study of COMP360 for Treatment Resistant Depression (COMP 006)
This is the second part of COMPASS Pathwhays’ Phase III clinical trial program exploring the effects of fixed repeated doses of COMP360 (25mg, 10mg & 1mg) in participants (n=568) with treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2023-02-01
Phase III
Blinded
568 participants
Interventional
A Single Dose of COMP360 for Treatment-Resistant Depression (COMP005)
This is the first part of COMPASS Pathwhays' Phase III clinical trial program comparing the effects of a single dose of COMP360 (25mg) to placebo in participants (n=378) with treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2022-11-31
Phase III
Blinded
255 participants
Interventional
Clinical Study of DMT in Healthy Adults
This open-label trial (n=30) seeks to evaluate the acute and subacute effects of inhaled DMT. Participants will be given a low dose (7mg/70kg) and then two hours later a higher dose (49mg/70kg). Participants will not receive psychological support.
Status: Recruiting
Start date: 2022-06-01
Phase I
Open
30 participants
Interventional
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (TherPsySE)
This trial (n=48) will follow therapists as they embark on their own psychedelic experiences. The trial's focus is on the benefits and risks to both the therapists and the patients (and their interaction).
Status: Not yet recruiting
Start date: 2022-12-01
Not Applicable
Open
48 participants
Interventional
Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder
The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.
Status: Enrolling by invitation
Start date: 2022-11-01
Phase I
Open
30 participants
Interventional
Effects of Psilocybin in Obsessive Compulsive Disorder
This study will test the feasibility, safety, and evidence for the efficacy of psilocybin administration in participants with obsessive-compulsive disorder (OCD).
Status: Not yet recruiting
Start date: 2022-09-30
Phase I
Open
30 participants
Interventional
Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder
The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.
Status: Not yet recruiting
Start date: 2023-01-01
Phase II
Open
15 participants
Interventional
PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout (PAPR)
This is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic.
Status: Not yet recruiting
Start date: 2023-01-01
Open
24 participants
Interventional
Effects of Psilocybin in Concussion Headache
This double-blind cross-over trial (n=24) investigates the effect of repeated doses of psilocybin (2x) at varying doses of psilocybin (1 or 10mg) on concussion headache.
Status: Recruiting
Start date: 2019-03-28
Phase I
Blinded
24 participants
Interventional
Single and Repeat Doses of DMT in Healthy Subjects
This double-blind trial (n=60) by Algernon Pharmaceuticals will give participants several 6-hour (you read that right) infusions of DMT. The first part will start with a 1.5mg bolus followed by 6.3mg (0.105mg p/m) each hour. If read correctly, the second part of the study will do six doses over six hours but doesn't specify if a continuous infusion will also be given.
Status: Not yet recruiting
Start date: 2022-11-01
Phase I
Blinded
60 participants
Interventional
Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action (Psilopain)
This open-label trial (n=20) will take EEG measures on participants who receive two doses of psilocybin (up to 25mg). Next to the brain measures, participants will be studied up to six months later.
Status: Not yet recruiting
Start date: 2022-08-15
Phase I
Open
20 participants
Interventional
SPL026 With or Without SSRIs in Participants With MDD
This open-label trial (n=24) investigates the difference between those who are and aren't taking antidepressants (SSRIs) who will receive SPL026 (DMT fumarate). As a Phase I study, the main concern is safety and tolerability. With 24 participants, some signal on effectiveness might be detected.
Status: Not yet recruiting
Start date: 2022-10-01
Open
24 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.