Psychedelic Trials

Understanding Neuroplasticity Induced by TrYptamines (UNITy): the effects of dimethyltryptamine (DMT) on drinking
This randomised, double-blind, placebo-controlled trial (n=60) will study the effects of dimethyltryptamine (DMT) on drinking behaviour and neuroplasticity in hazardous and harmful alcohol drinkers (AUD) who are not currently seeking treatment.
Status: Active, not recruiting
Start date: 2020-10-30
Phase II
Blinded
60 participants
Interventional
A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way
This interventional trial (n=44) studied the safety, tolerability, pharmacokinetics, and QT interval effects of different doses of COMP360 (psilocybin) in healthy volunteers, including an assessment of food effects.
Status: Completed
Start date: 2020-11-01
Phase I
Open
32 participants
Interventional
Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and effects of intravenous (IV) and intramuscular (IM) dosing of SPL028 (deuterated DMT fumarate [a serotonergic psychedelic]) in healthy volunteers and participants with major depressive disorder (MDD)
This randomised, double-blind, placebo-controlled trial (n=40) will study the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects of intravenous (IV) and intramuscular (IM) dosing of SPL028 (deuterated DMT fumarate) in healthy volunteers and participants with major depressive disorder (MDD).
Status: Completed
Start date: 2022-06-01
Phase II
Open
40 participants
Interventional
Pilot Study of RR-HNK in OCD ((HNKO))
This double-blind, placebo-controlled trial (n=45) will study the safety and efficacy of two dosage levels of intravenous (2R,6R)-Hydroxynorketamine (RR-HNK) in adults with obsessive-compulsive disorder (OCD).
Status: Not yet recruiting
Start date: 2024-12-01
Phase I
Blinded
45 participants
Interventional
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression (KAP)
This Phase II randomised, controlled clinical trial (n=70) will compare ketamine-assisted psychotherapy (KAP) to ketamine administered without psychotherapy (KET) for the treatment of major depressive disorder (MDD).
Status: Recruiting
Start date: 2024-08-01
Phase II
Open
70 participants
Interventional
Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy (PAP_OXT)
This observational pilot study (n=10) will examine salivary oxytocin levels during a single dose of LSD as part of psychedelic-assisted psychotherapy (PAP) for anxiety disorders or depression.
Status: Recruiting
Start date: 2024-08-05
Not Applicable
Open
10 participants
Observational
Optimizing Microdosing and Meditation (OMM)
This randomised controlled trial (n=24) will investigate the feasibility of combining meditation with psilocybin microdosing in healthy adults, comparing a group receiving only psilocybin microdoses to a group receiving both psilocybin microdoses and meditation training.
Status: Not yet recruiting
Start date: 2024-10-01
Not Applicable
Open
24 participants
Interventional
A Study of a Psilocybin Analog (CYB003) in Humans With Major Depressive Disorder (APPROACH)
This Phase III randomised, double-blind, placebo-controlled trial (n=220) will study the efficacy, safety, and tolerability of CYB003 (16mg), a synthetic psilocybin analogue, compared to placebo as an adjunctive treatment for major depressive disorder (MDD).
Status: Not yet recruiting
Start date: 2024-11-01
Phase III
Blinded
220 participants
Interventional
Psychedelic Virtual Reality
This observational trial (n=15) will evaluate a novel Virtual Reality Psychedelic (VRP) called DeepDream using the Meta Quest 3 device.
Status: Not yet recruiting
Start date: 2024-09-15
Not Applicable
Open
15 participants
Observational
Ketamine Therapy for Methamphetamine Use Disorder & HIV (KetaMet)
This single-arm pilot feasibility trial (n=12) will study the use of intramuscular (IM) ketamine (35-52.5mg/70kg) in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at risk for HIV disease.
Status: Not yet recruiting
Start date: 2025-01-01
Phase II
Open
12 participants
Interventional
MDMA-Assisted Therapy for Pathological Narcissism
This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy for participants diagnosed with pathological narcissism.
Status: Recruiting
Start date: 2024-08-27
Phase I
Open
12 participants
Interventional
A study on the safety, tolerability, and effects of GM-2505
This adaptive, randomised, double-blind, placebo-controlled trial (n=48) evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous doses of GM-2505 (second-gen, shorter duration, 5-HT2A agonist) in healthy volunteers.
Status: Completed
Start date: 2022-08-30
Not Applicable
Blinded
48 participants
Interventional
Ketamine-assisted psychological therapy to reduce alcohol relapse
This Phase III, multi-site trial (n=280) will examine the effectiveness of ketamine-assisted psychological therapy for reducing alcohol relapse in individuals with severe alcohol use disorder (AUD).
Status: Recruiting
Start date: 2024-06-25
Phase III
Open
280 participants
Interventional
Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression
This randomized, double-blind, placebo-controlled crossover trial (n=50) will investigate the efficacy and safety of (2R,6R)-hydroxynorketamine (HNK), an enhancer of synaptic glutamate release, in individuals with treatment-resistant major depressive disorder (MDD).
Status: Not yet recruiting
Start date: 2024-08-14
Phase II
Blinded
50 participants
Interventional
Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
This interventional trial (n=600) will evaluate whether cognitive training can enhance or extend the rapid antidepressant effects of ketamine in patients already receiving ketamine treatment as part of their clinical care.
Status: Not yet recruiting
Start date: 2024-11-01
Not Applicable
Blinded
600 participants
Interventional
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients (MOODBOOSTER)
This randomised, quadruple-blind, placebo-controlled Phase III trial (n=60) will study the early effects of ketamine compared to placebo as an adjunctive therapy with venlafaxine in inpatients with severe unipolar major depressive disorder (MDD).
Status: Not yet recruiting
Start date: 2024-09-01
Phase III
Blinded
60 participants
Interventional
Ketamine for Methamphetamine Use Disorder (KMD)
This randomised, double-blind, placebo-controlled trial (n=120) will study the efficacy of intravenous (IV) ketamine versus IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD).
Status: Not yet recruiting
Start date: 2024-08-01
Phase II
Blinded
120 participants
Interventional
IV Ketamine Vs. in Esketamine for MDD TRD
This observational study (n=80) compares the acute effects of intravenous ketamine (IV ketamine) versus intranasal esketamine (IN esketamine) in treating severe depression and suicidal ideation in patients with treatment-resistant depression (MDD-TRD).
Status: Recruiting
Start date: 2023-03-20
Not Applicable
Open
80 participants
Observational
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND) (TRANSCEND)
This open-label, Phase II trial (n=16) will assess the feasibility, tolerability, and preliminary efficacy of psilocybin (25mg) therapy for adults with chronic neuropathic pain and treatment-resistant depression (TRD).
Status: Not yet recruiting
Start date: 2024-09-01
Phase II
Open
16 participants
Interventional
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST) (SYNVEST)
This Phase II interventional trial (n=12) will evaluate the effects of psilocybin (25mg) with and without risperidone (1mg) on synaptic density in adults with treatment-resistant depression (TRD).
Status: Not yet recruiting
Start date: 2024-08-01
Phase II
Open
12 participants
Interventional
Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression (Psilo-BD)
This open-label, single-arm trial (n=30) aims to evaluate the neurobiological effects of a single dose of psilocybin (25mg) in individuals with treatment-resistant bipolar depression (TRBD).
Status: Not yet recruiting
Start date: 2024-08-01
Phase I
Open
30 participants
Interventional
Investigation to Understand and Optimize Psilocybin (OPTIMIZE)
This interventional trial (n=141) will investigate the potential enhancement of the antidepressant effects of psilocybin (25mg) through the addition of transcutaneous auricular Vagus Nerve Stimulation (taVNS).
Status: Not yet recruiting
Start date: 2025-02-01
Phase II
Blinded
141 participants
Interventional
Effects of Psilocybin on Shared Experience
This interventional trial (n=30) will examine the effects of psilocybin on brain synchrony and cognitive function in healthy volunteers.
Status: Not yet recruiting
Start date: 2024-09-01
Not Applicable
Open
30 participants
Interventional
Pharmacology of human decision making - Study of the effects of ketamine on healthy volunteers (18-55) making simple perceptual decisions
This Phase IV, placebo-controlled crossover trial (n=35) will investigate the impact of ketamine on perceptual decision-making in healthy volunteers.
Status: Recruiting
Start date: 2024-06-14
Phase IV
Blinded
35 participants
Interventional
Does psilocybin alter the brain's response to food choice and reward?
This interventional trial (n=10) will investigate whether psilocybin (20mg) alters the brain's response to food choice and reward in healthy adults.
Status: Not yet recruiting
Start date: 2024-08-01
Phase I
Open
10 participants
Interventional
Ketamine-assisted psychotherapy for methamphetamine use disorder
This open-label safety and feasibility pilot trial (n=20) will study ketamine-assisted psychotherapy for methamphetamine use disorder in adults.
Status: Not yet recruiting
Start date: 2024-09-02
Phase IV
Open
20 participants
Interventional
Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
This interventional trial (n=20) will investigate the efficacy and safety of psychedelic-assisted psychotherapy for the treatment of PTSD in individuals diagnosed with co-occurring borderline personality disorder (BPD), using MDMA (2-5x; 80+40mg).
Status: Not yet recruiting
Start date: 2024-07-26
Phase II
Open
20 participants
Interventional
Pilot study of administration of psilocybin in healthy volunteers within a marae setting
This interventional trial (n=12) will assess the feasibility and acceptability of administering psilocybin (25mg) to healthy volunteers within a marae setting (Māori) under clinical supervision.
Status: Not yet recruiting
Start date: 2024-08-01
Phase I
Open
12 participants
Interventional
Feasibility study testing the protocol of single dose of psilocybin given to people who have had little improvements with brief psychological intervention
This open-label trial (n=30) will study the feasibility of administering a single dose of psilocybin (25mg) to adults with mild to moderate depression or anxiety who have shown limited improvement with brief psychological intervention.
Status: Not yet recruiting
Start date: 2025-02-01
Phase II
Open
30 participants
Interventional
Mechanistic Studies of Psilocybin in Headache Disorders
This interventional trial (n=50) will explore the mechanisms of psilocybin in headache disorders, focusing on migraine sufferers and healthy controls.
Status: Not yet recruiting
Start date: 2024-09-01
Phase I
Blinded
49 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.