Psilocybin Whole Mushroom for Obsessive-Compulsive Disorder
This study is looking into whether psilocybin, a mind-altering drug, can help treat obsessive-compulsive disorder (OCD). Researchers believe psilocybin might change activity in brain areas linked to OCD. You might be able to join if you are 18 or older, have been diagnosed with moderate to severe OCD, and have not found relief with at least one standard treatment. The study will involve 30 participants who will receive different doses of whole psilocybin mushrooms in chocolate. Success will be measured by changes in your OCD symptoms using a scale called the Yale-Brown Obsessive Compulsive Scale (YBOCS) and by tracking any side effects. The current status of this study is unclear.
- Study design
- This is an interventional study with 30 participants, where you would be assigned by chance to receive a low, medium, or high dose of psilocybin.
- What's involved
- You would come to the University of Arizona CATS Research Unit for assessments, a preparation session, and four dosing sessions spaced about three weeks apart. On dosing days, you will be monitored for safety for several hours.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12-week treatment phase, you will be contacted monthly for 12 months for follow-up assessments.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07347405
Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
Recruiting
PHASE1Ages 18+InterventionalTreatmentFrancisco A MorenoInvestigator-initiated
~30 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Psilocybin 10 mgPsilocybin 20 mgPsilocybin 30 mg
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Yale Brown Obsessive Compulsive Scale
Measured over Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesArizona1
Study leadership
- Francisco Moreno, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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), UGT1A10, and UGT1A9 inhibitors
Other active OCD treatments (cognitive behavioral therapy \[CBT\] or other psychotherapy; electrical or magnetic device treatments; pharmacological treatments such as antidepressant medications (e.g., SSRIs, SNRIs, MAOIs, TCAs, 5HT2 blockers, NERIs, etc.), lithium, antipsychotic drugs, 5-HT2 antagonists such as pimavanserin, and glutamatergic acting medications)
5HT2 agonists (e.g., efavirenz, lorcaserin), which may alter the response to psilocybin
Serotonin-acting dietary supplements (e.g., 5-hydroxy-tryptophan, St. John's wort) due to potential for interaction with psilocybin and increased safety risks
Exclusion
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
Clinically significant renal or hepatic impairment, per clinical judgment of a study physician
EKG QTc ≥ 450 msec
Psychiatric comorbidity that may represent an acute risk to their own or other's safety, including history of bipolar disorder (I or II) in the participant or first degree relative, as well as any family history of psychosis.
Subjects cannot require any sedative, narcotic, or neuroleptic medications on a regular basis. Any of these medications they have taken should have been stopped long enough in the past to allow for their elimination and safe withdrawal prior to starting administration of the study drug. The specific time required will be dependent on the medication the patient was previously receiving.
Participants who are pregnant, breastfeeding, planning a pregnancy, or planning to donate sperm within three months post-last study drug administration.
Participants of childbearing potential or participants with partners of childbearing potential who engage in intercourse which could result in pregnancy are unwilling/unable to practice medically acceptable highly effective birth control (double barrier, oral and injectable pharmacological contraceptives, or surgical such as vasectomy or bilateral tubal occlusion) during the study and up to three months after the last study drug administration.
Suicide attempt within the 12 months prior to enrollment
Any condition for which MRI is contraindicated, at the discretion of a study investigator or the MRI technician, including: Pacemakers and defibrillators; artificial heart valves which are not MRI safe; any metal in head, spinal cord, eyes or chest; any electrical devices such as cochlear implants, nerve stimulators, deep brain stimulators, gastric pacemaker, or insulin or pain pumps; aneurysm clips; ferrous (i.e. non titanium alloy) implants in any part of the body.
Use within the week prior to screening of drugs of abuse as listed in the current US DOJ DEA Drugs of Abuse Resource Guide, including:
Cannabinoids (marijuana, synthetic cannabinoids)
Simulants (amphetamine, cocaine, methamphetamine, methylphenidate, modafinil)
Opioids (natural and synthetic),
Sedatives (benzodiazepines, barbiturates, GHB, zolpidem, zaleplon, zopiclone)
Hallucinogens (DMT, ibogaine, LSD, MDMA, psilocybin, psilocin, PSP)
Weight below 45kg
Allergy or significant intolerance to chocolate or cocoa
What this trial measures
- Yale Brown Obsessive Compulsive ScaleBaseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
Clinician rating scale to determine severity of OCD symptoms. Scores vary from 0 to 40. Higher scores represent greater severity of OCD symptoms.
- Adverse Event (AE) Tracking logWeekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
The Adverse Event tracking log will collect information on adverse health events reported throughout the research study.
- Visual Analogue Scale (VAS)Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Scale 0 (no symptoms at all) to 100 (maximum symptom severity)
Self-reported measure of intensity or frequency of pain or other various symptoms