Actively Recruiting
Open-Label Psilocybin Study in Transdiagnostic Population
Led by Yale University · Updated on 2026-03-11
50
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
U
Usona Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open-Label Psilocybin Study in Transdiagnostic Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one psychiatric symptom causing mild or greater functional impairment in the past 30 days as measured by DIAMOND or a WHODAS-2.0 12-item score over 16
- Fluent in English and able to understand and provide written informed consent
- Agree to have safe transportation arranged for after the dosing session
- Able to identify a physician or treater who can confirm safety for participation and consent to release medical information
- Able to swallow pills orally for psilocybin dosing
- Provide an adult contact who can assist in emergencies, provide transportation if needed, and report changes in mood or behavior
- Medically stable as determined by physical exam, labs, medical evaluation, and ECG
- Psychologically stable with stable psychotherapy for at least one month prior and expected stability during study
- If of childbearing potential, agree to use effective birth control and have a negative pregnancy test at screening and dosing
- Females who are fertile must not plan to become pregnant or donate eggs during study and follow-up period
You will not qualify if you...
- Personal or first-degree family history of primary psychotic disorder or Bipolar I disorder
- Active suicidal intent or recent suicidal/self-injurious behavior within 6 months
- Use of classic psychedelics within 3 months (excluding microdosing) or ketamine within 1 month
- Frequent structured use of classic psychedelics over past 10 years
- History of hallucinogen use disorder or intolerance to perception-altering drugs
- Use of 5-hydroxytryptophan or St. John's Wort
- Positive breathalyzer or urine drug screen (except prescribed opioids/benzodiazepines and cannabis with restrictions)
- Changes in psychotropic medication within past 3 months
- Recent use of MAOI, Lithium, or methadone
- Psychiatric conditions impairing therapeutic rapport
- Use of investigational drugs within 30 days
- Allergy to gelatin
- Hypertension or significant cardiovascular disease
- Abnormal ECG findings or prolonged QT interval
- Risk factors for torsades de pointes
- Moderate-to-severe liver or kidney impairment
- Use of vasoconstrictive or certain immunomodulatory medications recently
- Uncontrolled diabetes or significant thyroid dysfunction
- Any other condition posing safety risks or affecting ability to complete the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Connecticut Mental Health Center - Yale School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
S
Sarah Shnayder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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