A Randomized Double-masked Dose-controlled Trial to Assess the Tolerability, Safety, Subjective Experience, and Efficacy of Repeated Administration of Three Different Doses of Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
Francisco A Moreno
Summary
The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be assigned (by luck of the draw) to take a low, medium, or high dose whole psilocybin mushroom contained in three chocolate pieces, prepared for this study by the Scottsdale Research Institute.
Description
Participants will come to the University of Arizona CATS Research Unit in Tucson for assessment, if they are found to be fit for study participation, they will be scheduled for a preparation session with a study therapist and then will participate in a dosing session when they will ingest three pieces of chocolate containing psilocybin mushroom. They will answer questions of how they are feeling, and will be monitored for safety by two study staff members, and their vital signs will be checked every hour on the day they receive the study drug. The will be sent home with a responsible adult sel…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged 18 years old, and older * Have OCD (DSM-5) based on diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID). * At least moderate severity: Yale-Brown Obsessive Compulsive Scale (YBOCS) score ≥16. * Failed at least one adequate trial of guideline concordant treatment. * Considered safe for independent living * Subjects must discontinue use of any of the following prescription or over the counter (OTC) products or nutritional supplements at least two weeks prior to initiating double-blind treatment: * Monoamine oxidase (MAOI),…
Interventions
- DrugPsilocybin 10 mg
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
- DrugPsilocybin 20 mg
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
- DrugPsilocybin 30 mg
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
Location
- The Clinical and Translational Sciences Research CenterTucson, Arizona