RecruitingPhase 1NCT06442423

Open-Label Psilocybin Study in Transdiagnostic Population

Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study

Sponsor

Yale University

Enrollment

50 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Anxiety Depression - Major Depressive Disorder PTSD Substance Use Transdiagnostic PTSD Symptoms Substance Use Disorder (SUD)OCD

Summary

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study gives psilocybin (a psychedelic compound derived from certain mushrooms) to people experiencing a range of psychiatric symptoms — such as depression, anxiety, PTSD, or addiction — to see whether it can reduce symptoms and improve mental health and daily functioning across different diagnoses. **You may be eligible if...** - You have at least one psychiatric symptom causing meaningful interference with your daily life in the past 30 days - You are fluent in English and able to understand the consent process and risks - You meet other health and safety criteria set by the study team **You may NOT be eligible if...** - You have a personal or family history of psychosis, schizophrenia, or bipolar I disorder - You are at high risk of self-harm or suicide - You are currently taking medications that interact with psilocybin (such as lithium or certain antidepressants) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.This is an open-label clinical trial with a single treatment arm. This is an open-label clinical trial with no blinding.