Actively Recruiting
Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
Led by Francisco A Moreno · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
F
Francisco A Moreno
Lead Sponsor
A
Arizona Biomedical Research Commission (ABRC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years old, and older
- Diagnosed with obsessive-compulsive disorder (OCD) according to DSM-5 criteria
- Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 16 or higher indicating at least moderate severity
- Have failed at least one adequate trial of guideline-recommended treatment for OCD
- Considered safe for independent living
- Must discontinue certain medications and supplements at least two weeks before treatment, including MAOIs, UGT1A10 and UGT1A9 inhibitors, other active OCD treatments (e.g., CBT, electrical or magnetic devices, antidepressants, lithium, antipsychotics, 5-HT2 antagonists, glutamatergic medications), 5HT2 agonists, and serotonin-acting dietary supplements
- Fluoxetine must be stopped at least six weeks before treatment
You will not qualify if you...
- Current active substance use disorder or personal history of psychosis
- History of psychosis among first-degree relatives
- Medical illnesses complicating cardiovascular safety or drug metabolism, including stroke, myocardial infarction, uncontrolled hypertension, tachycardia, prolonged QT interval, valvular heart disease, or significant arrhythmia within one year
- Unstable chronic obstructive pulmonary disease or severe sleep apnea
- Significant renal or hepatic impairment
- EKG QTc interval of 450 milliseconds or more
- Psychiatric conditions posing acute safety risks, including bipolar disorder in participant or first-degree relatives and any family history of psychosis
- Regular use of sedative, narcotic, or neuroleptic medications
- Pregnancy, breastfeeding, planning pregnancy, or planning sperm donation within three months after last study drug dose
- Unwillingness or inability to use highly effective birth control during study and for three months after last dose
- Suicide attempt within the past 12 months
- Conditions contraindicating MRI, such as pacemakers, artificial heart valves, metal implants, electrical devices, aneurysm clips, or ferrous implants
- Use of drugs of abuse within one week prior to screening, including cannabinoids, stimulants, opioids, sedatives, and hallucinogens
- Weight below 45 kg
- Allergy or significant intolerance to chocolate or cocoa
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Clinical and Translational Sciences Research Center
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
T
The clinical and translational research center
CONTACT
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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