Obsessive - Compulsive DisorderPhase 1/2NCT06992999
Psilocybin for Treatment of OCD-2
A Phase 1/2 study testing Low Dose Psilocybin and High Dose Psilocybin in people with Obsessive - Compulsive Disorder, run by Francisco A Moreno at 1 site in United States.
Trial summary
Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with 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?
- Low Dose Psilocybin and High Dose Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to Dec 2028
- Phase
- Phase 1/2
- 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, such as uncontrolled hypertension, severe cardiac disease, or kidney or liver failure.
- 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.
- 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.
- Women who are pregnant, breastfeeding, or unwilling/unable to practice medically acceptable highly effective birth control (double barrier, oral and injectable pharmacological contraceptives) during the study.
- Suicidal behavior within the 12 months prior to enrollment, or significant risk of suicide as determined by the CSSRS items 4 (suicidal ideation with intent) and 5 (suicidal ideation with intent and plan) during screening or baseline assessment.
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arizona-Tucson
Tucson, Arizona, 85724
Esmeralda Terrazas, 520-626-8000, esmeralda97h@arizona.edu
Francisco Moreno, MD
About this study
Official title: Psilocybin for Treatment of Obsessive Compulsive Disorder
Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD. The investigators propose to study 20 patients with symptomatic OCD who are not taking mind altering medications or street drugs, to participate in a 12 week study. Participants will be assigned (by luck of the draw) to take low or high dose psilocybin in four dosing sessions separated by 3 weeks. Measurements for the severity of OCD, ability to function, perception of quality of life, safety and tolerability will be measured at baseline prior to drug administration, during the dosing periods, and at the end of study. Other measurements will include brain imaging via fMRI and brain tracing via electroencephalogram (EEG). The investigators believe that during medically supervised dosing sessions, both doses of psilocybin will be safe and well tolerated, and will reduce OCD symptoms. Because psilocybin is a potent drug and especially at the higher dose may induce altered states of consciousness, a thoughtfully implemented procedure for participant safety is in place. Information will be obtained to explore the effects of altered states of consciousness in the outcome of treatment and to find the mechanism of benefit.
Read the detailed description
Obsessive-Compulsive Disorder (OCD) affects millions of Americans at some point during their lifetime, representing a great deal of individual suffering, social, and fiscal cost. Despite this, currently available medications fail to help as many as 40% of OCD patients, and those who respond to treatment often experience troublesome residual symptoms 4. Psilocybin holds promise as a novel approach in the treatment of OCD, supported by preliminary evidence that it achieves response and remission rates exceeding conventional interventions .
The broad long-term objectives of this research are to improve our available treatment options for OCD and advance the specific knowledge of neural mechanism explaining treatment response. Building on the investigative team's decades long work with synthetic psilocybin, data obtained during this proposed early phase clinical study may help improve the life of people affected with OCD and minimize society's burden.
The investigators propose a randomized, controlled trial of four sessions of psilocybin assigned to either low dose (10mg) or high dose (30 mg) in double masked fashion to 20 (10 per group) symptomatic and medication-free OCD patients. The study will evaluate the tolerability, safety, subjective experience, and efficacy of psilocybin for improving OCD, obtain the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention study with dosing informed by this trial, and explore mechanism of anti-obsessional action.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- Low Dose Psilocybin, High Dose Psilocybin
- Keywords
- obsessive compulsive disorder, OCD, psilocybin, psychedelic, psychedelic experiences
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose PsilocybinDrug
10mg dose of psilocybin
High Dose PsilocybinDrug
30mg dose of psilocybin
| Study group | Role | What they receive |
|---|---|---|
| Low Dose psilocybin (10mg) | Active comparator | Subjects will receive a low dose (10mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks. Receives: Drug: Low Dose Psilocybin |
| High dose psilocybin (30mg) | Active comparator | Subjects will receive a high dose (30mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks. Receives: Drug: High Dose Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of orally administered psilocybin
Determine the acute safety and tolerability of orally administered psilocybin at low dose (10mg) and high dose (30mg) as measured with the Systematic Assessment for Treatment Emergent Events (SAFTEE) scale.
Measured: 12 months
Secondary outcomes (1)
Efficacy of oral administered psilocybin in patient with OCD
Determine the efficacy of two different doses (10mg and 30mg) of psilocybin as a treatment for OCD, and explore whether there may be a dose-response relationship. This will be based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start8 Sep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial of four sessions of psilocybin assigned to one of two dosing groups 1) low dose (10mg) 2) high dose (30mg) in a double masked fashion.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco A Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor-investigator, Francisco A Moreno, University of Arizona
- Investigators
- Francisco Moreno, MD, Principal investigator, University of Arizona, College of Medicine, Tucson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992999
- Sponsor's protocol ID
- 00006264
- Status last verified
- May 2026
- First submitted
- 9 May 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin for Treatment of Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06992999
- Acronym / sponsor ID
- 00006264
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- obsessive compulsive disorder, OCD, psilocybin, psychedelic, psychedelic experiences
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Francisco A MorenoUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2025 (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.
Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD. The investigators propose to study 20 patients with symptomatic OCD who are not taking mind altering medications or street drugs, to participate in a 12 week study. Participants will be assigned (by luck of the draw) to take low or high dose psilocybin in four dosing sessions separated by 3 weeks. Measurements for the severity of OCD, ability to function, perception of quality of life, safety and tolerability will be measured at baseline prior to drug administration, during the dosing periods, and at the end of study. Other measurements will include brain imaging via fMRI and brain tracing via electroencephalogram (EEG). The investigators believe that during medically supervised dosing sessions, both doses of psilocybin will be safe and well tolerated, and will reduce OCD symptoms. Because psilocybin is a potent drug and especially at the higher dose may induce altered states of consciousness, a thoughtfully implemented procedure for participant safety is in place. Information will be obtained to explore the effects of altered states of consciousness in the outcome of treatment and to find the mechanism of benefit.
Detailed description
Obsessive-Compulsive Disorder (OCD) affects millions of Americans at some point during their lifetime, representing a great deal of individual suffering, social, and fiscal cost. Despite this, currently available medications fail to help as many as 40% of OCD patients, and those who respond to treatment often experience troublesome residual symptoms 4. Psilocybin holds promise as a novel approach in the treatment of OCD, supported by preliminary evidence that it achieves response and remission rates exceeding conventional interventions .
The broad long-term objectives of this research are to improve our available treatment options for OCD and advance the specific knowledge of neural mechanism explaining treatment response. Building on the investigative team's decades long work with synthetic psilocybin, data obtained during this proposed early phase clinical study may help improve the life of people affected with OCD and minimize society's burden.
The investigators propose a randomized, controlled trial of four sessions of psilocybin assigned to either low dose (10mg) or high dose (30 mg) in double masked fashion to 20 (10 per group) symptomatic and medication-free OCD patients. The study will evaluate the tolerability, safety, subjective experience, and efficacy of psilocybin for improving OCD, obtain the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention study with dosing informed by this trial, and explore mechanism of anti-obsessional action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled trial of four sessions of psilocybin assigned to one of two dosing groups 1) low dose (10mg) 2) high dose (30mg) in a double masked fashion.
| Arm | Type | Receives |
|---|---|---|
| Low Dose psilocybin (10mg) | Active comparator | Drug: Low Dose PsilocybinSubjects will receive a low dose (10mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks. |
| High dose psilocybin (30mg) | Active comparator | Drug: High Dose PsilocybinSubjects will receive a high dose (30mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks. |
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 (17 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, such as uncontrolled hypertension, severe cardiac disease, or kidney or liver failure.
- 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 |
|---|---|---|
| Low Dose Psilocybin10mg dose of psilocybin | Drug | Low Dose psilocybin (10mg) |
| High Dose Psilocybin30mg dose of psilocybin | Drug | High dose psilocybin (30mg) |
Primary outcome
Safety and tolerability of orally administered psilocybin
Time frame: 12 months
Determine the acute safety and tolerability of orally administered psilocybin at low dose (10mg) and high dose (30mg) as measured with the Systematic Assessment for Treatment Emergent Events (SAFTEE) scale.
1 secondary outcome
Efficacy of oral administered psilocybin in patient with OCD
Time frame: 12 months
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 12 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Francisco Moreno, MD principal investigator
University of Arizona, College of Medicine, Tucson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Dose Psilocybin and High Dose Psilocybin 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 17 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: opening soon, as of the sponsor's last update on 12 May 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Esmeralda Terrazas ((520) 626-8000, esmeralda97h@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of orally administered psilocybin (time frame: 12 months). 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 12 May 2026.