10
Participants
Start Date
July 7, 2025
Primary Completion Date
January 31, 2027
Study Completion Date
January 31, 2027
Psilocybin
Two sequential administrations of 25 mg psilocybin, 4 weeks apart.
Therapeutic Support
"Five preparatory in-person psychotherapy sessions will be offered before the first administration session during weeks 1, 2, 3, 4, and 5. The optional second administration session will be preceded by a shorter 60 min preparatory session the day before.~Each administration session will be followed by 3 integration sessions and will adopt a Mindfulness-based CBT approach (M-CBT), in which a therapist will help the participant to process their experience and how to translate this into actual changes in everyday life.~If participants prefer more psychological support after the second administration session, they will be offered additional, optional therapy sessions for the duration of the trial regardless if they opted for a second administration session or not."
RECRUITING
The University of Texas Health Science Center at Houston, Houston
Anne and Don Fizer Foundation
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER