Clinical Research Directory

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.

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.

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

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.

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.

PRoMiSS: Psilocybin and the Role of Music in Set and Setting

The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are: Does autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists? How are brain and body responses - including EEG activity, respiration, heart rate, and skin conductance - influenced by autobiographically salient music under psilocybin? Do brain and body responses to specific music features differ when the music is autobiographically salient compared to non-salient playlists? Researchers will compare five music conditions: three conditions where an 80-minute block of autobiographically salient music is placed at different points in the 6-hour psilocybin session (0-80 minutes, 80-160 minutes, or 240-320 minutes), a standardized Johns Hopkins psilocybin playlist, and an ambient playlist with no autobiographical content. Participants will: * Take a single oral dose of psilocybin (25 mg) during one study session * Listen to one of the five music conditions while reclining in a comfortable setting * Complete questionnaires about emotions, acute, subjective effects, insight, etc. * Undergo EEG and physiological monitoring (respiration, heart rate, skin conductance) during the session * Complete MRI brain scans before the session and 1 week after psilocybin * Return for follow-ups at 1 day, 1 week, and 1 month after psilocybin * At 1 month, complete a qualitative interview and a nondrug EEG music listening session, where the participant's hear either music from the participant's own psilocybin session or music from another participant's session

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