Psychedelic Trials

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 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
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
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
The Effect of Esketamine on Sleep Disturbance
This interventional trial (n=200) will investigate the effect of a single low dose of esketamine during surgical abortion in patients with sleep disturbance.
Status: Not yet recruiting
Start date: 2024-05-03
Not Applicable
Blinded
200 participants
Interventional
Ketamine for Veterans With Parkinson's Disease (KPD)
This double-masked, active placebo-controlled, single-dose randomised trial (n=80) will investigate the effects of intravenous (IV) ketamine versus remimazolam for depression in Veterans with Parkinson's disease (PD).
Status: Not yet recruiting
Start date: 2024-07-01
Phase II
Blinded
80 participants
Interventional
A double-blind, randomised trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients
This double-blind, randomised trial (n=32) will compare the effects of methylphenidate- versus MDMA-assisted therapy (120mg) for mood and anxiety symptoms in advanced-stage cancer patients.
Status: Recruiting
Start date: 2023-07-31
Phase II
Blinded
32 participants
Interventional
Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness
This parallel-group, double-blinded, randomised controlled trial (n=35) investigates the use of psilocybin (25mg), combined with psychotherapy, for managing depression and anxiety in terminally ill patients.
Status: Active, not recruiting
Start date: 2020-01-23
Phase II
Blinded
35 participants
Interventional
Effect of ketamine on anxiety ratings in patients with anxiety disorders
This non-randomised trial (n=25) investigates the effects of ketamine on anxiety ratings in patients with anxiety disorders, specifically Generalized Anxiety Disorder (GAD) or Social Phobia (SP).
Status: Completed
Start date: 2015-11-10
Phase I
Blinded
25 participants
Interventional
Neural Circuit Effects of Ketamine in Depression
This interventional trial (n=120) aims to explore the neural circuit-specific mechanisms of ketamine's effect on anhedonia and anxiety in individuals with major depressive disorder (MDD).
Status: Recruiting
Start date: 2024-01-31
Phase IV
Blinded
120 participants
Interventional
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI (ESKETAM)
This observational trial (n=13) was conducted by the University Hospital, Strasbourg, France. The study aimed to assess the tolerance and potential synergistic effect of combining intranasal esketamine with non-selective MAOIs in patients with depression and anxiety disorders.
Status: Completed
Start date: 2022-04-11
Not Applicable
Open
13 participants
Observational
Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults
This randomised, double-blind, placebo-controlled trial (n=0, withdrawn) aimed to assess the efficacy of micro-dosed psilocybin (PSIL428) in reducing anxiety and/or depression levels in adults.
Status: Withdrawn
Start date: 2022-09-15
Phase II
Blinded
0 participants
Interventional
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
This interventional trial (n=30) aims to examine the feasibility, safety, and effects of psilocybin-assisted (25mg) psychotherapy on depression and/or anxiety in individuals undergoing treatment for advanced cancer.
Status: Not yet recruiting
Start date: 2024-06-30
Phase II
Blinded
30 participants
Interventional
A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD) With Depressive Symptoms
This double-blind, active-controlled study (n=36) aims to evaluate the preliminary clinical efficacy, safety, tolerability, and pharmacokinetics of CYB004 (DMT) in participants diagnosed with Generalized Anxiety Disorder (GAD) with depressive symptoms.
Status: Not yet recruiting
Start date: 2024-05-1
Phase I
Blinded
36 participants
Interventional
Social Anxiety MDMA-Assisted Therapy Investigation
This is a randomised, open-label delayed treatment trial (n=90) aiming to evaluate the safety and efficacy of MDMA-assisted therapy for social anxiety disorder (SAD) in adults.
Status: Active, not recruiting
Start date: 2022-04-13
Phase II
Open
88 participants
Interventional
Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
This open-label clinical trial (n=12) aims to assess the feasibility of ketamine-assisted psychotherapy (KAP) for adults with non-operable gastrointestinal (GI) cancers suffering from existential distress.
Status: Recruiting
Start date: 2023-10-13
Phase I
Open
11 participants
Interventional
Lysergic Acid Diethylamide (LSD) in Palliative Care (LPC)
This randomized, double-blind, active-placebo controlled trial (n=60) will evaluate the effects of LSD on psychosocial distress in patients suffering from an end-stage fatal disease with a life expectancy of 12 weeks to 2 years.
Status: Not yet recruiting
Start date: 2023-09-01
Phase II
Blinded
60 participants
Interventional
Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
This phase I/II trial (n=56) will study the safety and side effects of psilocybin in combination with therapy for treating cancer-related anxiety in patients with metastatic cancer. Psilocybin is being studied to treat anxiety or depression in patients with advanced cancer. Participants will receive psilocybin orally and participate in group and individual therapy sessions.
Status: Not yet recruiting
Start date: 2023-09-01
Phase I
Blinded
56 participants
Interventional
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
This open-label trial (n=10) serves as a preliminary study to see if psilocybin (in combination with psychotherapy) may help treat anxiety, depression and chronic pain (demoralization) in cancer survivors.
Status: Not yet recruiting
Start date: 2022-08-31
Phase I
Open
10 participants
Interventional
A Dose-Finding Study of MM-120 for the Treatment of Anxiety Symptoms
This is a Phase II, multi-centre, randomized, double-blind, parallel-group, dose-finding study to assess the effect of four doses of MM-120 (25, 50, 100 or 200 μg LSD freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).
Status: Recruiting
Start date: 2022-06-27
Phase II
Blinded
200 participants
Interventional
Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)
This multicenter, triple-blind, Phase II, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).
Status: Not yet recruiting
Start date: 2022-10-01
Blinded
100 participants
Interventional
Psilocybin Therapy in Advanced Cancer
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose psilocybin 1mg) in the treatment of anxiety, depression, and existential distress in advanced cancer.
Status: Not yet recruiting
Start date: 2022-11-01
Phase II
Blinded
200 participants
Interventional
KRN-101 for Cancer-Related Distress
This study will investigate the effects of KR-101 (a psilocybin-based medicine) in participants with cancer-related distress.
Status: Planned
Phase II
Open
Interventional
Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial
In this study, we will complete a randomised controlled trial to test a 7 week (2 dose) psilocybin-assisted psychotherapy for the treatment of GAD. 72 individuals will be randomly assigned to receive two doses either psilocybin (25mg or 30mg, oral) or placebo (diphenhydramine, 75mg or 100mg, oral) with three weeks between doses.
Status: Recruiting
Start date: 2022-01-10
Phase II
Blinded
70 participants
Interventional
Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer
The primary objective of this study is to evaluate the ability to recruit and retain participants and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to inoperable pancreaticobiliary cancer. Secondary objectives include pre/post and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.
Status: Not yet recruiting
Start date: 2022-05-10
Phase I
Open
24 participants
Interventional
Frontline Clinician Psilocybin Study
We aim to investigate the effects of a single dose of psilocybin, delivered in the context of pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the coronavirus disease of 2019 (COVID) pandemic.
Status: Recruiting
Start date: 2021-12-15
Phase I
Blinded
30 participants
Interventional
Social Anxiety MDMA-Assisted Therapy Investigation (SAMATI)
This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype.
Status: Recruiting
Start date: 2022-02-02
Phase II
Blinded
20 participants
Interventional
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease (PDP)
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.
Status: Recruiting
Start date: 2021-08-15
Phase II
Open
10 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.

?>