Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06160284
Phase
PHASE1
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Participants will receive a single dose of psilocybin administered in 20 mg or 25 mg doses depending on the participant's weight: 20 mg (among participants \< 70 kg) or 25 mg (among participants \>70 kg). Participants will be administered psilocybin at CNRU, within 1-2 weeks of the baseline \[11C\]-UCB-J PET.

Study Details

This study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the \[11C\]-UCB-J radiotracer while inpatient.

Key Dates

Start date
May 28, 2025
Status verified
May 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Current OUD diagnosis + psilocybin
    All participants will receive a \[11C\]-UCB-J PET scan and fMRI with in 1-2 weeks pre and post treatment with one dose of Psilocybin. Intravenous lines will be used for phlebotomy and administration of the \[11C\]-UCB-J radiotracer. On the PET scanning day, a radial arterial catheter may be inserted.

Primary Outcome Measure

Change in Synaptic Density [ Time Frame: baseline and 1-2 weeks post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-

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By research site
Yale University· New Haven, CT

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