Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancisco A Moreno
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Concurrent active substance use disorder, or a personal history of psychosis.
History of psychosis among first degree relatives as determined by the Family Interview for Genetic Studies (FIGS)32
Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion. Examples include: 1) Cardiovascular conditions: lifetime history of stroke, lifetime myocardial infarction, uncontrolled hypertension (resting blood pressure >140/90 mmHg), tachycardia (resting heart rate >100 beats per minute), elongated QT interval corrected by Fridericia's formula (QTcF; interval >450 msec), participants with existing valvular heart disease, or clinically significant arrhythmia (<1 year prior to signing the ICF); 2) Metabolic conditions: subjects with diabetes should have a stable diabetes treatment regimen and no history of diabetic ketoacidosis, hyperglycemic coma, or no hypoglycemic episodes with glucose below 54 mg/dL in the 3 months prior to baseline, and fasting glucose >70 mg/dL at baseline; 3) Severe renal impairment: eGFR <45 mL/min/1.73 m²); and Liver failure: Child-Pugh Classes B and C.
Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea
Trial design
Treatments tested in this trial
- Psilocybin 10 mg
- Psilocybin 20 mg
- Psilocybin 30 mg
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Francisco A Moreno
Lead sponsor
University of Arizona
Sponsor institution
Arizona Biomedical Research Commission (ABRC)
Collaborator
Source ClinicalTrials.gov