Psilocybin

7

Review clinical trials related to Psilocybin. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms

Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants. The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \[0.16-1.65\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.

Participants needed: 172
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire de NīmesUpdated: Jul 1, 2026Locations: 8
Eligibility criteria

Confirmed DSM-5 diagnosis of severe AUD. [+4]

The subject is participating in an interventional study, a clinical trial, or a... [+18]

Status: Not yet recruiting

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.

Participants needed: 83
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Participants with histologically or cytologically confirmed breast, colorectal,... [+14]

Malignancy treated with curative intent and no active disease for ≥ 5 years befo... [+54]

Status: Not yet recruiting

Group PACBT for Depression

This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.

Participants needed: 30
Trial details
Phase: Phase 2Age: 21-60Biological sex: AllType: InterventionalSponsor: University of California, Los AngelesUpdated: May 4, 2026Locations: 1
Eligibility criteria

Ages 21-60, [+10]

A personal or family history (first-degree) of psychosis or mania [+16]

Status: Recruiting

The RECAP2 Study: Midazolam and Psilocybin

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing. Participants will: * Receive one of four possible combinations of medications * Undergo an MRI * Complete questionnaires * Undergo transcranial magnetic stimulation (TMS) and EEG

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: Apr 3, 2026Locations: 1
Eligibility criteria

Age 18 to 65 years at screening, of any identified gender and racial/ethnic grou... [+4]

Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation [+5]

Status: Not yet recruiting

The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.

In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia). After psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor. This study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research. The goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.

Participants needed: 50
Trial details
Phase: Phase 1Age: 21-65Biological sex: AllType: InterventionalSponsor: Gabriella GobbiUpdated: Feb 25, 2026
Eligibility criteria

Male or Female adults ages 21-65 at the time of screening. [+7]

Any psychiatric, cardiovascular, neurological, or other disorders that may be ag... [+15]

Status: Not yet recruiting

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.

Participants needed: 45
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Dec 29, 2025Locations: 1
Eligibility criteria

1. Ability to provide informed consent in English. [+17]

1. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder. [+17]

Status: Recruiting

Psychedelic-assisted Group Program for First Responders

This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. Group 1 (control): 12-week group-based program, with a breathwork day at week 10 Group 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10 Assessment timepoints: * Baseline * Mid-program (Week 6) * End of program (Week 12) * 6-month follow up

Participants needed: 32
Trial details
Phase: Phase 1, Phase 2Age: 19-65Biological sex: AllType: InterventionalSponsor: Empower Research IncUpdated: Jun 24, 2024Locations: 1
Eligibility criteria

Male or female, 19 to 65 years of age [+20]

Current or past history of schizophrenia, psychotic disorder (unless substance i... [+13]