Open-Label Psilocybin Study in Transdiagnostic Population

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06442423
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 17, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open-label
    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.

Primary Outcome Measure

Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health Center - Yale School of MedicineNew HavenConnecticut06519
Gabby Agin-Liebes, PhD
[email protected]
(203) 444-1795

Find similar trials in New Haven, CT

By condition
PTSD (post-traumatic stress disorder)Substance use disorder
By specialty
PsychiatryMental healthBehavioral healthAddiction medicine
By research site
Connecticut Mental Health Center - Yale School of Medicine· New Haven, CT

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