Psychedelic Trials

Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants (R-S-)
This randomised, triple-blind, placebo-controlled Phase I crossover trial (n=24) will compare the acute effects of two enantiomers of MDMA—R-MDMA (300mg) and S-MDMA (100mg)—in healthy adult participants.
Status: Not yet recruiting
Start date: 2025-05-01
Phase I
Blinded
24 participants
Interventional
Psilocybin With Intracranial Neural Sensing (PINS)
This open-label, single-arm Phase I trial (n=20) will study the effects of a single 10 mg oral dose of psilocybin on neural activity, pain, and cognition in adults with chronic pain who have implanted brain-sensing deep brain stimulation (DBS) devices.
Status: Not yet recruiting
Start date: 2025-05-01
Phase I
Open
20 participants
Interventional
Psilocybin-Assisted Therapy for Intergenerational Trauma
This open-label Phase II trial (n=100) will study the safety, tolerability, and potential therapeutic effects of psilocybin (2 x 25 mg oral doses, taken at least 3 weeks apart) in the biological children of genocide survivors who are living with mood and anxiety disorders.
Status: Not yet recruiting
Start date: 2025-06-01
Phase II
Open
100 participants
Interventional
Administration of Psilocybe Cubensis Mushrooms with or Without Fluoxetine with or Without Fluoxetine for Refractory Depression: a Randomized Double-blind Controlled Trial Controlled Clinical Trial - COGUNILA (COGUNILA)
This randomised, quadruple-blind, placebo-controlled Phase I/II trial (n=50) will investigate the antidepressant, psychedelic, and adverse effects of Psilocybe cubensis mushrooms (equivalent to 30 mg of psilocybin) with or without daily fluoxetine (20mg) in adults with treatment-resistant depression.
Status: Recruiting
Start date: 2024-09-05
Phase I
Blinded
50 participants
Interventional
Psilocybin for Methamphetamine Addiction
This open-label, single-arm early Phase I trial (n=20) will assess the feasibility, tolerability, and potential effectiveness of a single 25 mg dose of psilocybin in promoting abstinence from methamphetamine in adults undergoing residential addiction treatment.
Status: Not yet recruiting
Start date: 2025-03-01
Phase I
Open
20 participants
Interventional
Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants (LPD)
This randomised, placebo-controlled, triple-blind Phase I crossover trial (n=24) will compare the acute and subacute effects of LSD (150µg), psilocybin (30mg), and DMT (up to 2 mg/min intravenous infusion) in healthy adults, with all sessions standardised using ketanserin (20 mg IV) to end the psychedelic experience after three hours.
Status: Recruiting
Start date: 2025-04-01
Phase I
Blinded
24 participants
Interventional
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD (SUN004)
This Phase II, open-label trial (n=35) will study the efficacy, safety, and tolerability of psilocybin (25mg) combined with therapy in women with post-traumatic stress disorder (PTSD) stemming from sexual assault.
Status: Not yet recruiting
Start date: 2025-08-01
Phase II
Open
35 participants
Interventional
Understanding and Treating Suicidal Ideation With Ketamine
This open-label, Phase II/III trial (n=36) will study the effects of ketamine (35mg/70kg via intravenous infusion) on suicidal ideation in individuals with major depressive disorder (MDD).
Status: Recruiting
Start date: 2025-04-08
Phase II
Open
35 participants
Interventional
Antidepressant Response of DMT Masked With Propofol (DMT4D)
This randomised, placebo-controlled, quadruple-masked trial (n=112) will investigate whether the antidepressant effects of DMT (2 mg/min over 20 minutes) in patients with major depressive disorder (MDD) depend on the subjective psychedelic experience, by comparing DMT with and without sedation using propofol.
Status: Not yet recruiting
Start date: 2025-04-01
Phase II
Blinded
112 participants
Interventional
Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
This two-part observational trial (n=50) will evaluate the safety and efficacy of intravenous ketamine infusions (1.5–2 mg/kg over 3–4 hours) in reducing pain among patients diagnosed with fibromyalgia.
Status: Active, not recruiting
Start date: 2020-11-30
Not Applicable
Open
50 participants
Observational
A Phase 1, Open-label, Pilot Study to Assess the Safety, Feasibility and Initial Efficacy of IV infused Psilocin (TRP-8803) Administration in Concert with Psychotherapy Among Adult Patients with Binge Eating Disorder (BED)
This Phase I open-label trial (n=12) will investigate the safety, feasibility, and initial efficacy of intravenous psilocin (TRP-8803), administered in two doses (ranging from 6.7 mg to 15 mg) in combination with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).
Status: Not yet recruiting
Start date: 2025-06-01
Phase I
Open
12 participants
Interventional
Feasibility of oral ketamine for bipolar depression: a 20-week open-label study
This open-label Phase II trial (n=30) will investigate the feasibility, safety, and antidepressant effects of oral ketamine (starting at 1 mg/kg, up to 2 mg/kg) in adults with bipolar depression.
Status: Not yet recruiting
Start date: 2025-06-23
Phase II
Open
30 participants
Interventional
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma (STARLIGHT)
This open-label, Phase II trial (n=15) will investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of post-traumatic stress disorder (PTSD) in US military veterans. Participants will receive two psilocybin doses—15 mg in the first session and 25 mg in the second session—alongside psychotherapy.
Status: Recruiting
Start date: 2025-01-30
Phase II
Open
15 participants
Interventional
Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence (PsiPTSD)
This quadruple-blind, randomised controlled trial (n=76) will study the effects of psilocybin (25mg or 1mg) combined with Acceptance and Commitment Therapy (ACT) in adult survivors of intimate partner violence (IPV) with post-traumatic stress disorder (PTSD).
Status: Not yet recruiting
Start date: 2025-08-01
Phase II
Blinded
76 participants
Interventional
Psilocybin with Psychological Support (Psi-PS) for Military Veterans and First Responders with Co-occurring PTSD & Alcohol Use Disorder (AUD) (Psi-PS)
This Phase II, double-blind, placebo-controlled trial (n=40) will investigate the safety, effectiveness, and lasting effects of psilocybin (25mg) combined with psychological support (Psi-PS) in military veterans and first responders with both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD).
Status: Not yet recruiting
Start date: 2025-03-01
Phase II
Blinded
40 participants
Interventional
Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (MDMA-Psilo)
This double-blind, placebo-controlled, crossover trial (n=24) will investigate the acute effects of psilocybin (20mg) when co-administered with MDMA (100mg) in healthy adults.
Status: Recruiting
Start date: 2025-04-01
Phase I
Blinded
24 participants
Interventional
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans with Major Depressive Disorder" (APPROACH)
This Phase III, placebo-controlled, randomised, quadruple-blind trial (n=220) will assess the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analogue, as an adjunctive treatment for major depressive disorder (MDD). Participants will receive either 16 mg of CYB003 or a placebo in two dosing sessions, approximately three weeks apart, while continuing their current antidepressant medication and receiving psychological support.
Status: Recruiting
Start date: 2024-11-15
Phase III
Blinded
220 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 (MDMA-AT) (80 mg for the first session, 120 mg for the second and third, with an optional supplemental dose of 50% of the initial dose) for participants diagnosed with pathological narcissism.
Status: Recruiting
Start date: 2024-08-27
Phase I
Open
12 participants
Interventional
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) (EXTEND)
This open-label, phase III long-term extension trial (n=220) aims to assess the safety and long-term efficacy of CYB003 in participants with major depressive disorder (MDD). Participants will receive up to three doses of 16 mg of CYB003, administered in medicine sessions approximately three weeks apart.
Status: Not yet recruiting
Start date: 2025-02-23
Phase III
Open
220 participants
Interventional
Pilot Study of RR-HNK in OCD ((HNKO))
This double-blind, placebo-controlled trial (n=45) will assess the safety and efficacy of two doses of intravenous (2R,6R)-Hydroxynorketamine (RR-HNK) in adults with obsessive-compulsive disorder (OCD). Participants will receive either 17.5mg/70kg or 35mg/70kg of RR-HNK, or a placebo, via a single infusion.
Status: Not yet recruiting
Start date: 2024-12-01
Phase I
Blinded
45 participants
Interventional
Psychedelic Virtual Reality
This observational, case-crossover trial (n=15) will evaluate the subjective experience of a novel virtual reality programme (VRP), DeepDream, in comparison to a standard dose of psychedelics.
Status: Not yet recruiting
Start date: 2025-02-15
Not Applicable
Open
15 participants
Observational
Psilocybin Mechanism of Action (MOA)
This randomised, quadruple-blind, placebo-controlled trial (n=60) will investigate the role of the 5-HT2A receptor in mediating the subjective and antidepressant effects of psilocybin in individuals with Major Depressive Disorder (MDD). Participants will receive a single dose of psilocybin (25mg) combined with either pimavanserin (34mg; atypical antipsychotic) or a placebo.
Status: Recruiting
Start date: 2025-02-01
Phase II
Blinded
60 participants
Interventional
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults with Depression
This open-label, early Phase I trial (n=10) will assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.
Status: Not yet recruiting
Start date: 2025-01-01
Phase I
Open
10 participants
Interventional
Ketamine, SGB and Combination Treatment for TBI
This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI)-associated headaches.
Status: Not yet recruiting
Start date: 2025-02-15
Phase II
Blinded
175 participants
Interventional
FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression
This open-label observational trial (n=20) will investigate the effects of intravenous ketamine on treatment-resistant bipolar depression, with an interventional component of functional magnetic resonance imaging (fMRI).
Status: Recruiting
Start date: 2024-11-12
Phase II
Open
20 participants
Observational
Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy (PatACT)
This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.
Status: Not yet recruiting
Start date: 2024-10-30
Phase I
Blinded
40 participants
Interventional
ACT_for Alcohol Use Disorder and Depression
This interventional trial (n=20) will assess the feasibility of combining Acceptance and Commitment Therapy (ACT) with ketamine intervention in patients with alcohol use disorder (AUD) and comorbid treatment-resistant depression (TRD).
Status: Not yet recruiting
Start date: 2025-05-01
Not Applicable
Open
20 participants
Interventional
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression (KAP)
This single-site, randomised, controlled clinical trial (n=70) will compare ketamine-assisted psychotherapy (KAP) to standard medical ketamine administration (KET) for the treatment of major depressive disorder (MDD), using doses ranging from 21 mg/70 kg to 70 mg/70 kg.
Status: Recruiting
Start date: 2025-01-01
Phase II
Blinded
70 participants
Interventional
Optimizing Microdosing and Meditation (OMM)
This open-label, randomised trial (n=24) will examine the feasibility of combining meditation with psilocybin microdosing in healthy adults.
Status: Not yet recruiting
Start date: 2024-10-01
Not Applicable
Open
24 participants
Interventional
Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy (PAP_OXT)
This observational pilot study (n=10) will investigate the reactivity of salivary oxytocin during a single dose of lysergic acid diethylamide (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

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.