Psychedelic Trials

Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)
This triple-blinded, randomised, active, placebo-controlled trial (n=34) will investigate the effects of ketamine in combination with standard inpatient addiction therapy for adults suffering from depression and alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2024-01-01
Phase I
Blinded
34 participants
Interventional
Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial (K-PASS)
This double-blinded, placebo-controlled feasibility trial (n=32) investigates the potential of a postoperative low-dose ketamine infusion to prevent depressive symptoms in neurosurgical patients with a history of depression.
Status: Completed
Start date: 2022-04-25
Phase III
Blinded
32 participants
Interventional
[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine
This interventional trial (n=1, terminated) aimed to measure the effects of ketamine infusion on cAMP signalling in the human brain to ascertain if ketamine contributes to its antidepressant effects by modulating cAMP levels.
Status: Terminated
Start date: 2023-02-08
Phase I
Open
0 participants
Interventional
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
This double-blind, placebo-controlled trial (n=1, terminated) aimed to determine whether perioperative administration of ketamine could increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo.
Status: Terminated
Start date: 2019-12-17
Phase II
Blinded
1 participants
Interventional
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)
This open-label, long-term extension safety study (n=1146) of esketamine Nasal Spray (Spravato) in treatment-resistant depression (SUSTAIN-3) aims to assess the safety and tolerability of Spravato in participants with treatment-resistant depression (TRD).
Status: Completed
Start date: 2016-06-09
Phase III
Open
1146 participants
Interventional
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
This randomised, placebo-controlled, double-blind, double-dummy three-way crossover trial (n=40) aims to investigate the effect of BI 409306, BI 425809, and Lamotrigine on ketamine-induced cognitive deficits in healthy male subjects.
Status: Completed
Start date: 2020-12-01
Phase I
Blinded
40 participants
Interventional
The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine (Check)
This randomised, double-blind clinical trial (n=0, terminated) aimed to compare the effectiveness of ketamine (21mg/70kg) to prochlorperazine (Compazine) in treating benign headaches in the Emergency Department.
Status: Terminated
Start date: 2016-08-01
Phase III
Blinded
5 participants
Interventional
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
This prospective, randomised, open-label trial (n=5) compared the analgesic efficacy and safety of a proprietary formulation of orally administered aspirin and ketamine (AOK) to Nurtec (Rimegepant) in adult patients presenting to the Emergency Department (ED) with acute headache.
Status: Completed
Start date: 2021-04-22
Phase IV
Open
5 participants
Interventional
Mindfulness-assisted Psychedelic Therapy (MAPT)
This randomised, open-label, parallel arm trial (n=40) will examine the potential synergy between psilocybin (25mg) and mindfulness training in improving mental health.
Status: Not yet recruiting
Start date: 2024-07-01
Phase II
Open
40 participants
Interventional
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin (PSI-1V2)
This interventional trial (n=92) aims to evaluate the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP/PAT, 25mg, 2x) involving family members in adults with treatment-resistant major depressive disorder (TRMDD).
Status: Recruiting
Start date: 2024-02-05
Phase II
Blinded
92 participants
Interventional
Molecular Imaging Study of Harmine/​DMT: a Basic Research Approach (HaD-PET)
This Phase I interventional trial (n=16), known as HaD-PET, aims to investigate the acute cerebrometabolic effects of harmine/DMT (ayahuasca/pharmahuasca) in healthy volunteers using quantitative FDG-PET.
Status: Recruiting
Start date: 2024-01-22
Phase I
Blinded
16 participants
Interventional
Psilocybin-Assisted Therapy in Treatment-Resistant Depression
This Phase III interventional trial (n=20), conducted by the University of North Carolina, Chapel Hill, aims to assess the efficacy and safety of Psilocybin-Assisted Therapy (PAT, 25mg, 2x) in adults with treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2024-04-19
Phase III
Blinded
20 participants
Interventional
Psilocybin for Hospitalized Patients With Treatment-resistant Depression (PSIHOS-D)
This open-label feasibility trial (n=100) aims to assess the safety and feasibility of psilocybin-assisted psychotherapy for hospitalized patients with treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2024-04-01
Phase II
Open
100 participants
Interventional
Psilocybin in Alcohol Use Disorder With Comorbid Depression (PAD)
This randomised, double-blind trial (n=30) is set to examine the feasibility, acceptability, and preliminary effectiveness of psilocybin therapy (25mg, 2x) in treating alcohol use disorder (AUD) with comorbid depression after withdrawal, alongside standard treatment.
Status: Not yet recruiting
Start date: 2024-01-01
Not Applicable
Blinded
30 participants
Interventional
Low-Income Group Psilocybin Assisted Therapy for Depression (LIGPATD)
This open-label feasibility study (n=24) will investigate the potential of group psilocybin-assisted therapy for depression in low-income adults in Oregon.
Status: Not yet recruiting
Start date: 2024-08-01
Not Applicable
Open
24 participants
Interventional
Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PAP-OCD)
This open-label clinical trial (n=10) evaluates the feasibility, clinical effects, and safety of psilocybin-assisted psychotherapy (25mg, 2x) for treatment-resistant obsessive-compulsive disorder (OCD).
Status: Not yet recruiting
Start date: 2024-04-01
Phase I
Open
10 participants
Interventional
Psilocybin for Major Depressive Disorder (MDD) (uAspire)
This Phase III, randomized, double-blind, multicenter trial (n=240) aims to evaluate the efficacy, safety, and tolerability of psilocybin (5-25mg) in adults with Major Depressive Disorder (MDD).
Status: Recruiting
Start date: 2024-03-05
Phase III
Blinded
240 participants
Interventional
MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents
This open-label fixed-dose trial (n=10) aims to determine the safety and feasibility of MDMA-assisted psychotherapy (80-120mg) for adolescents with treatment-resistant post-traumatic stress disorder (PTSD).
Status: Not yet recruiting
Start date: 2025-07-01
Phase II
Open
10 participants
Interventional
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
This intervention trial (n=60) will evaluate the effects of MDMA-Assisted Therapy (MDMA-AT) versus Somatic Experiential Acceptance Intensive Trauma-based therapy (SEA-IT) on psychological, relational, and hyperarousal-related neural reactivity mechanisms in male Veterans with PTSD and Moral Injury.
Status: Recruiting
Start date: 2024-02-18
Phase III
Open
60 participants
Interventional
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
This Phase I intervention trial (n=80) will assess the safety, tolerability, and pharmacokinetics of psilocybin (MLS101 ) in healthy participants.
Status: Recruiting
Start date: 2024-03-01
Phase I
Blinded
80 participants
Interventional
Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
This double-blind, placebo-controlled trial (n=24) aims to evaluate the effectiveness of ketamine treatment compared to midazolam over three consecutive days in patients with difficult-to-treat depression.
Status: Recruiting
Start date: 2021-09-01
Phase IV
Blinded
24 participants
Interventional
MDMA and prosocial behavior: The role of the 2a-serotonin receptor
This interventional trial (n=20) investigates the neurobiological mechanisms underlying MDMA-induced prosocial behaviour, specifically focusing on the role of the 5-HT2a receptor.
Status: Recruiting
Start date: 2013-01-30
Not Applicable
Blinded
20 participants
Interventional
Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
This open-label feasibility study (n=21) will assess the combination of IV ketamine with Mindfulness-Based Cognitive Therapy (MBCT) for the treatment of depression.
Status: Recruiting
Start date: 2022-03-30
Phase IV
Open
21 participants
Interventional
Ketamine Treatment for PTSD and MDD in TBI
This interventional trial (n=40) aims to investigate the efficacy and safety of subanesthetic ketamine in treating depression and post-traumatic stress disorder (PTSD) among Veterans with mild to moderate traumatic brain injury (TBI).
Status: Not yet recruiting
Start date: 2024-03-01
Phase II
Blinded
39 participants
Interventional
Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression
This interventional trial (n=20) aims to assess the effects of simultaneous administration of oral aspirin and oral ketamine as an adjunct to oral antidepressant therapy for treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2022-12-06
Phase IV
Open
20 participants
Interventional
Auditory MMN EEG in TRD in Response to Ketamine
This observational trial (n=30) will investigate the neurocomputational model of ketamine treatment response predictions in treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2022-10-03
Open
30 participants
Observational
A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 (Psilocin) in Healthy Adult Participants
This Phase I, open-label, dose-escalation study (n=9) aims to assess the safety and pharmacokinetics of a single intravenous infusion of psilocin (active metabolite of psilocybin; TRP-8803; 8-21mg) in healthy adult participants.
Status: Not yet recruiting
Start date: 2024-05-24
Phase I
Open
9 participants
Interventional
A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis
This double-blind, randomized, low-dose comparator-controlled clinical trial (n=84) aims to assess the efficacy and safety of psilocybin (25mg; PEX010) in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis.
Status: Not yet recruiting
Start date: 2024-05-31
Phase II
Blinded
84 participants
Interventional
Toward Embodied Healing: Feasibility of a Psilocybin-Assisted Psychotherapy for Partially Recovered Anorexia Nervosa and Persistent Body Image Disturbance. A Manualised, Three-Dose, Open-Label Case Study
This open-label interventional trial (n=10) assesses the feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy (1x 5mg, 2x 25mg) for body image disturbance (BID) in women with a history of anorexia nervosa.
Status: Not yet recruiting
Start date: 2024-04-01
Phase I
Open
10 participants
Interventional
Assessing the effects of Lysergic acid diethylamide (LSD) microdosing in people experiencing depression (LSDDEP2)
This randomised, double-dummy, triple-blind, placebo-controlled, parallel groups trial (n=90) investigates the effects of LSD microdosing (2-20μg) in patients with major depressive disorder (MDD) compared to an active placebo.
Status: Not yet recruiting
Start date: 2024-03-11
Phase II
Blinded
90 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.

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