Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
This Phase III, double-blind, placebo-controlled, parallel-arm trial (n=120) will study the effects of psilocybin microdosing (2–3mg, 4 days per week for 2 weeks) on psychological and existential distress in patients receiving palliative care for advanced illness.
Status: Not yet recruiting
Start date: 2025-08-01
Phase III
Blinded
120 participants
Interventional
This Phase II open-label trial (n=15) will study the effects of psilocybin (25mg) administered in the context of Psilocybin-assisted Existential, Attachment and Relational (PEARL) therapy for caregivers of patients with advanced cancer.
Status: Not yet recruiting
Start date: 2025-07-02
Phase II
Open
15 participants
Interventional
This Phase I randomised, single-blind trial (n=20) will study the effects of multiple low doses of psilocybin (MLS101) on brain activity, safety, tolerability, and pharmacokinetics in healthy adult volunteers.
Status: Not yet recruiting
Start date: 2025-07-01
Phase I
Blinded
20 participants
Interventional
This open-label, single-arm Phase IV trial (n=47) will evaluate the efficacy and safety of esketamine nasal spray (flexibly dosed at 56mg or 84mg) in Korean adults with treatment-resistant depression (TRD).
Status: Recruiting
Start date: 2025-06-09
Phase IV
Open
47 participants
Interventional
This early Phase I, randomised, placebo-controlled trial (n=48) will study the psychological and behavioural effects of a low dose of LSD (13µg) by comparing participants' experiences when they do or do not know what drug they are receiving.
Status: Recruiting
Start date: 2025-06-26
Phase I
Blinded
48 participants
Interventional
This open-label Phase I/II trial (n=12) will study the effects of oral ketamine (beginning at 35mg/70kg and increasing to 140mg/70kg) in combination with prolonged exposure therapy for the treatment of post-traumatic stress disorder (PTSD).
Status: Planned
Start date: 2025-07-31
Phase I
Open
12 participants
Interventional
This randomised, double-blind, placebo-controlled Phase IV trial (n=50) will study the effects of a single low-dose intravenous infusion of esketamine (14mg/70kg over 40 minutes) combined with oral duloxetine (60mg/day) on depression in patients with postherpetic neuralgia (nerve pain that continues after a shingles infection).
Status: Not yet recruiting
Start date: 2025-06-15
Phase IV
Blinded
50 participants
Interventional
This open-label, randomised controlled trial (n=30) will study whether ketamine (four infusions over two weeks) combined with mindfulness-based cognitive therapy improves quality of life, pain, depression, and PTSD symptoms more effectively than mindfulness therapy alone in adults with both chronic pain and PTSD.
Status: Not yet recruiting
Start date: 2025-10-01
Phase I
Open
30 participants
Interventional
This observational trial (n=100) will study the metabolic effects of esketamine (administered nasally) in patients with treatment-resistant major depressive disorder (TRD), using a non-targeted metabolomic approach to identify changes in biochemical pathways.
Status: Recruiting
Start date: 2023-04-01
Not Applicable
Open
100 participants
Observational
This Phase II, randomised, placebo-controlled, double-blind trial (n=75) will assess the therapeutic effects of a single intravenous dose of ketamine (56mg/70kg) combined with real-time fMRI neurofeedback (rt-fMRI NFT) on alcohol use disorder (AUD).
Status: Not yet recruiting
Start date: 2025-05-01
Phase II
Blinded
75 participants
Interventional
This randomised, double-blind, placebo-controlled Phase II trial (n=60) will study the feasibility, safety, and acceptability of oral ketamine (60–180 mg, administered twice weekly) as a treatment for adults with long-standing anorexia nervosa and comorbid treatment-resistant depression.
Status: Not yet recruiting
Start date: 2025-06-12
Phase II
Blinded
60 participants
Interventional
This Phase IIa, placebo-controlled, double-blind trial (n=50) will study the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin (oral solution) in adults with generalised anxiety disorder (GAD).
Status: Recruiting
Start date: 2025-05-06
Phase II
Blinded
50 participants
Interventional
This open-label, randomised crossover trial (n=25) will investigate the effects of intravenous (IV) ketamine (35mg/70kg over one hour) combined with different music conditions—self-selected music, therapist-selected music, or silence—on chronic noncancer pain.
Status: Recruiting
Start date: 2025-06-01
Not Applicable
Open
25 participants
Interventional
This open-label Phase I trial (n=15) will assess the feasibility and safety of a single 25 mg dose of pharmaceutical-grade psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.
Status: Not yet recruiting
Start date: 2025-08-01
Phase I
Open
15 participants
Interventional
This randomised, double-masked Phase I/II trial (n=20) will study the safety, tolerability, and efficacy of psilocybin (10mg vs 30mg) across four sessions for the treatment of obsessive-compulsive disorder (OCD).
Status: Not yet recruiting
Start date: 2025-08-01
Phase I
Blinded
20 participants
Interventional
This Phase I, double-blind, active-controlled trial (n=40) will investigate the safety and potential therapeutic effects of co-administered MDMA and psilocybin in military Veterans diagnosed with post-traumatic stress disorder (PTSD).
Status: Not yet recruiting
Start date: 2025-06-01
Phase I
Blinded
40 participants
Interventional
This Phase I, open-label trial (n=4) will assess the safety and pharmacokinetics of a single intravenous dose of psilocin (TRP-8803; 5 mg loading over 20 minutes followed by 5 mg maintenance over 120 minutes) in healthy adults undergoing psychedelic-assisted psychotherapy.
Status: Planned
Start date: 2025-09-01
Phase I
Open
4 participants
Interventional
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
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.
