Obsessive-Compulsive DisorderPhase 1Mushroom-OCDNCT07347405
Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.
A Phase 1 study testing Psilocybin 10 mg, Psilocybin 20 mg and Psilocybin 30 mg in people with Obsessive-Compulsive Disorder, run by Francisco A Moreno at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Psilocybin 10 mg, Psilocybin 20 mg and Psilocybin 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 31 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
- Note that fluoxetine must be discontinued at least 6 weeks prior to initiating double-blind treatment.
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Coordinator contact
United States1 site, 1 recruiting
- Recruiting
The Clinical and Translational Sciences Research Center
Tucson, Arizona, 85724
Study Coordinator, (520) 626-4804, OCD@psychiatry.arizona.edu
About this study
Official title: 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.
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.
Read the detailed 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 selected by the patient after they are felt to be safe once the effects of the drug have resolved. Participants will receive four different doses separated by about three weeks. After they complete the treatment phase, they will be contacted monthly for follow up assessment of efficacy, and safety.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Psilocybin 10 mg, Psilocybin 20 mg, Psilocybin 30 mg
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 10 mgDrug
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
Psilocybin 20 mgDrug
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
Psilocybin 30 mgDrug
Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.
| Study group | Role | What they receive |
|---|---|---|
| Low dose 10 mg | Experimental | Whole dried psilocybin mushroom containing 10 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. Receives: Drug: Psilocybin 10 mg |
| Middle dose 20 mg | Experimental | Whole dried psilocybin mushroom containing 20 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. Receives: Drug: Psilocybin 20 mg |
| High dose 30 mg | Experimental | Whole dried psilocybin mushroom containing 30 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. Receives: Drug: Psilocybin 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
Clinician rating scale to determine severity of OCD symptoms. Scores vary from 0 to 40. Higher scores represent greater severity of OCD symptoms.
Measured: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
Adverse Event (AE) Tracking log
The Adverse Event tracking log will collect information on adverse health events reported throughout the research study.
Measured: Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
Visual Analogue Scale (VAS)
Self-reported measure of intensity or frequency of pain or other various symptoms
Measured: 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)
Secondary outcomes (3)
World Health Organization's quality of life assessment (WHOQOL-BREF)
A 26-item psychometric questionnaire to measure quality of life and functional ability. Raw scores are converted to transformed scores in four health related domains. Higher scores represent higher quality of life.
Measured: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
Short form health survey (SF-36)
Subject self-reporting health survey to monitor and assess functional impairment
Measured: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Functionality scales are transformed to range from 0 to 100 with 0 being maximal disability and 100 being no disability.
Columbia-Suicide Severity Rating Scale (C-SSRS)
A suicide risk assessment tool for prospective monitoring of suicidal ideation and behavior.
Measured: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Individuals with positive ideation or behavior scores can be categorized into low, moderate or high risk of suicide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco A Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Responsible party
- Sponsor-investigator, Francisco A Moreno, University of Arizona
- Investigators
- Francisco Moreno, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347405
- Sponsor's protocol ID
- 00005573
- Acronym
- Mushroom-OCD
- Status last verified
- May 2026
- First submitted
- 22 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07347405
- Acronym / sponsor ID
- Mushroom-OCD / 00005573
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Francisco A MorenoUniversity, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 selected by the patient after they are felt to be safe once the effects of the drug have resolved. Participants will receive four different doses separated by about three weeks. After they complete the treatment phase, they will be contacted monthly for follow up assessment of efficacy, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose 10 mg | Experimental | Drug: Psilocybin 10 mgWhole dried psilocybin mushroom containing 10 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. |
| Middle dose 20 mg | Experimental | Drug: Psilocybin 20 mgWhole dried psilocybin mushroom containing 20 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. |
| High dose 30 mg | Experimental | Drug: Psilocybin 30 mgWhole dried psilocybin mushroom containing 30 mg of psilocybin will be mixed in a chocolate matrix and administered to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin 10 mgOral administration of whole dried psilocybin mushrooms contained in a chocolate matrix. | Drug | Low dose 10 mg |
| Psilocybin 20 mgOral administration of whole dried psilocybin mushrooms contained in a chocolate matrix. | Drug | Middle dose 20 mg |
| Psilocybin 30 mgOral administration of whole dried psilocybin mushrooms contained in a chocolate matrix. | Drug | High dose 30 mg |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: Baseline, 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 log
Time frame: Weekly 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)
Time frame: 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
3 secondary outcomes
World Health Organization's quality of life assessment (WHOQOL-BREF)
Time frame: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
Short form health survey (SF-36)
Time frame: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Functionality scales are transformed to range from 0 to 100 with 0 being maximal disability and 100 being no disability.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Individuals with positive ideation or behavior scores can be categorized into low, moderate or high risk of suicide.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Coordinator contact
Francisco Moreno, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin 10 mg, Psilocybin 20 mg and Psilocybin 30 mg in people with Obsessive-Compulsive Disorder, run by Francisco A Moreno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The clinical and translational research center ((520) 626-8000, OCD@psychiatry.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (time frame: Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.