This randomised, double-blind, placebo-controlled Phase III trial (n=140) will evaluate the efficacy and safety of a single oral dose of MM120 (100 µg LSD D-tartrate) for the treatment of major depressive disorder (MDD).
Status: Recruiting
Start date: 2025-04-14
Phase III
Blinded
140 participants
Interventional
This randomised, double-blind, placebo-controlled Phase III trial (n=60) will investigate the efficacy and safety of subcutaneous ketamine (35-70mg/70kg, twice weekly for four weeks) as an add-on treatment for adolescents experiencing a major depressive episode with suicidal ideation and/or behaviour.
Status: Not yet recruiting
Start date: 2025-05-01
Phase III
Blinded
60 participants
Interventional
This randomised, quadruple-blind, placebo-controlled Phase II trial (n=50) will assess the effects of ketamine (52.5mg/70kg, intramuscularly, four times over two weeks) on opioid craving and withdrawal symptoms in adults newly entering methadone treatment for opioid use disorder.
Status: Not yet recruiting
Start date: 2025-08-01
Phase II
Blinded
50 participants
Interventional
This randomised, quadruple-blind, placebo-controlled Phase III trial (n=90) will study the effectiveness, safety, and tolerability of psilocybin (25 mg)–assisted therapy compared to an active placebo (1 mg psilocybin) in individuals with treatment-resistant depression associated with bipolar II disorder.
Status: Not yet recruiting
Start date: 2025-06-01
Phase III
Blinded
90 participants
Interventional
This open-label Phase II trial (n=20) will evaluate the feasibility, safety, and effectiveness of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory posttraumatic stress disorder (PTSD). Participants will receive two MDMA sessions—first 80 mg plus 40 mg, then 120 mg plus 60 mg—integrated into a four-week inpatient therapy programme that includes manualised psychotherapy and non-drug preparatory and integrative sessions.
Status: Not yet recruiting
Start date: 2025-05-01
Phase II
Open
20 participants
Interventional
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
