Actively Recruiting
Investigation to Understand and Optimize Psilocybin
Led by Charles Raison · Updated on 2025-05-23
141
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
C
Charles Raison
Lead Sponsor
U
Usona Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.
CONDITIONS
Official Title
Investigation to Understand and Optimize Psilocybin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Current diagnosis of Major Depressive Disorder with a depressive episode lasting 60 or more consecutive days at screening
- Medically healthy with no significant medical conditions that would affect safety or participation
You will not qualify if you...
- History or presence of psychiatric or medical conditions posing safety risks or interfering with participation, including bipolar disorder, psychosis, seizure disorder, or cardiovascular disease
- Family history of psychotic disorders in a first-degree relative
- Active suicidal ideation with a specific plan within the past 2 weeks
- Suicide attempt within the past 6 months
- Current substance use disorder
- Abnormal ECG findings increasing risk during participation
- Unable or unwilling to stop prescription psychotropic medications during the study
- Any condition or behavior deemed unsuitable by the investigator for safety or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vail Health Behavioral Health
Edwards, Colorado, United States, 81632
Actively Recruiting
Research Team
P
Program Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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