Obsessive-compulsive Disorder (OCD)Phase 1PSILOCDNCT03300947
Psilocybin for Treatment of Obsessive Compulsive Disorder
A Phase 1 study testing Psilocybin 100 mcg/kg, Psilocybin 300 mcg/kg and Lorazepam 1 mg in people with Obsessive-compulsive Disorder (OCD), run by University of Arizona at 1 site in United States.
Trial summary
This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-compulsive Disorder (OCD)
- What is being tested?
- Psilocybin 100 mcg/kg, Psilocybin 300 mcg/kg and Lorazepam 1 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 30 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have moderate to severe OCD (DSM-5) after diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID-R).
- Failed at least one adequate attempted routine care treatment.
- Considered safe for independent living
Who cannot join
- Concurrent psychosis, active substance use disorder, or a personal history of psychosis.
- 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
- Psychiatric comorbidity that may represent an acute risk to their own or others' safety.
- Subjects may not be using antidepressant medication for OCD for at least two weeks before receiving study drug, and they 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 birth control during the study.
- Allergy to lorazepam.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works.
Read the detailed description
The study seeks to improve our ability to treat and improve the lives of people who have obsessive-compulsive disorder (OCD) by exploring the benefits of psilocybin, a mind-altering drug that changes activity in brain areas believed to be involved in OCD. Anecdotal reports and results from previous research support this idea. This two-phase study will enroll patients with symptomatic OCD who are not taking mind-altering medications or street drugs.
During Phase One, neither participants nor the investigators will know which drugs or doses are administered. This information will be available if it is medically necessary to reveal which drugs and doses were administered. Five subjects in each group will receive study drug a total of four times, separated by one week. During Phase Two, participants will not know which drugs or doses they receive, but the investigators will know. All participants will receive psilocybin at some point during study participation.
Participants will be randomly assigned to one of the following groups:
- Low dose (100 µg/kg) psilocybin,
- High dose (300 µg/kg) psilocybin, or
- Lorazepam (1 mg), a calming medication. Lorazepam is used often for anxiety and will be used to mask which drug participants receive.
Participants will spend approximately 12 hours at the research site under observation during each visit, until they are free of the mind-altering effects of the drug and are determined by the psychiatrist to be safe to go home accompanied by a responsible adult. The effects of low versus high doses, and the additive effects of repeated doses will be analyzed and will be compared to the effects of lorazepam.
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Being tested
- Psilocybin 100 mcg/kg, Psilocybin 300 mcg/kg, Lorazepam 1 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 100 mcg/kgDrug
Also called Psilocybine, "magic mushrooms"
Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms").
Psilocybin 300 mcg/kgDrug
Also called Psilocybine, "magic mushrooms"
Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms").
Lorazepam 1 mgDrug
Also called Ativan, Intensol
A medication used to treat anxiety belonging to a class of drugs known as benzodiazepines, which act on the central nervous system to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
| Study group | Role | What they receive |
|---|---|---|
| High-dose Psilocybin | Experimental | Psilocybin 300 mcg/kg once per week, every week, for 8 weeks Receives: Drug: Psilocybin 300 mcg/kg |
| High- or Low-dose Psilocybin | Experimental | Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks Receives: Drug: Psilocybin 100 mcg/kg; Drug: Psilocybin 300 mcg/kg |
| High-dose Psilocybin or Lorazepam | Placebo comparator | Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks Receives: Drug: Psilocybin 300 mcg/kg; Drug: Lorazepam 1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-phase effects on Obsessive-Compulsive symptom severity
Prospective Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) score comparing each psilocybin dose and active placebo (Lorazepam).
Measured: weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)
Secondary outcomes (7)
Acute Incidence of Treatment Emergent Adverse Events
Prospective active inquiry of adverse events with the SAFTEE-GI (Systematic Assessment For Treatment Emergent Events-General Inquiry) comparing each psilocybin dose and active placebo (Lorazepam)
Measured: At 0, and 24 hours after blinded medication ingestion
Duration of Effects on Obsessive-Compulsive symptom severity
Prospective Naturalistic Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) after repeated administration of study drug.
Measured: Follow-up assessments will be conducted weekly over the phone weekly (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days).
Long Term Incidence and Duration of Treatment Emergent Psychiatric Adverse Events
Prospective Assessment with SCID-I (Structured Clinical Interview for DSM-5 Disorders) psychotic screening tool will assess for onset of psychopathology or hallucinogen induced disorders after repeated use.
Measured: Follow-up assessments will be conducted weekly over the phone (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days).
Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD) assessed by Error-related negativity (voltage) and mid-frontal theta power (time-frequency approach)
Prospective Assessment of Error Related brain activity comparing each psilocybin dose and active placebo (Lorazepam).
Measured: Baseline, and 9-10 hours after ingestion of study dose 1, 4, and 8.
Prospective Self-Assessment of Depression Symptoms
Prospective Assessment of Quick Inventory of Depressive Symptomatology (QIDS) Score comparing each psilocybin dose and active placebo (Lorazepam).
Measured: Baseline, 24 hours after each dose during 8 week active phase, and during the follow-up phase (weekly for one month after last dose, monthly for three months beginning 28 days after last dose, and then once at 6 months after last dose.
Prospective Clinician-Rated Assessment of Depression Symptoms
Prospective Assessment of Montgomery-Asberg Depression Rating Scale (MADRS) Score comparing each psilocybin dose and active placebo (Lorazepam).
Measured: Baseline, 4 weeks, 8 weeks, and during the follow-up phase (weekly for one month after last dose, monthly for three months beginning 28 days after last dose, and then once at 6 months after last dose
Changes in functional connectivity: 1) between the Caudate Nucleus (CN) and Orbital Frontal Cortex (OFC); 2) within the default mode network (DMN).
Prospective Assessment of Functional Connectivity in CN and OFC and in DMN comparing each psilocybin dose and active placebo (Lorazepam). Also examining whether magnitude of symptom reduction is related to changes in functional connectivity.
Measured: Imaging at baseline, and 9-10 hours post ingestion on weeks 1, 4, and 8. YBOCS at baseline and 8 hours after ingestion at weeks 1, 4, and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start2 Jan 2019
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Model description
- All participants will be randomly assigned to administration of low dose (100 µg/kg) psilocybin, High dose (300 µg/kg) psilocybin, or Lorazepam (1 mg). Eight different sessions divided in two phases will ensure all subjects are exposed to psilocybin at some point during the study in a blinded fashion.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco A Moreno, University of Arizona
- Investigators
- Francisco A. Moreno, MD, Principal investigator, Professor of Psychiatry and Associate Vice President, Diversity and Inclusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300947
- Sponsor's protocol ID
- 1707613822
- Acronym
- PSILOCD
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2017
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006 Nov;67(11):1735-40. doi: 10.4088/jcp.v67n1110.
PubMed 17196053Moreno FA, Allen KE, Wiegand CB, Dunne R, Prickett JI, Bayze B, Allen JJB. A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive-compulsive disorder. J Psychopharmacol. 2026 May;40(5):837-849. doi: 10.1177/02698811261424214. Epub 2026 Mar 13.
PubMed 41825921
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. 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
- NCT03300947
- Acronym / sponsor ID
- PSILOCD / 1707613822
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 4 Oct 2017 (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.
This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works.
Detailed description
The study seeks to improve our ability to treat and improve the lives of people who have obsessive-compulsive disorder (OCD) by exploring the benefits of psilocybin, a mind-altering drug that changes activity in brain areas believed to be involved in OCD. Anecdotal reports and results from previous research support this idea. This two-phase study will enroll patients with symptomatic OCD who are not taking mind-altering medications or street drugs.
During Phase One, neither participants nor the investigators will know which drugs or doses are administered. This information will be available if it is medically necessary to reveal which drugs and doses were administered. Five subjects in each group will receive study drug a total of four times, separated by one week. During Phase Two, participants will not know which drugs or doses they receive, but the investigators will know. All participants will receive psilocybin at some point during study participation.
Participants will be randomly assigned to one of the following groups:
- Low dose (100 µg/kg) psilocybin,
- High dose (300 µg/kg) psilocybin, or
- Lorazepam (1 mg), a calming medication. Lorazepam is used often for anxiety and will be used to mask which drug participants receive.
Participants will spend approximately 12 hours at the research site under observation during each visit, until they are free of the mind-altering effects of the drug and are determined by the psychiatrist to be safe to go home accompanied by a responsible adult. The effects of low versus high doses, and the additive effects of repeated doses will be analyzed and will be compared to the effects of lorazepam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will be randomly assigned to administration of low dose (100 µg/kg) psilocybin, High dose (300 µg/kg) psilocybin, or Lorazepam (1 mg). Eight different sessions divided in two phases will ensure all subjects are exposed to psilocybin at some point during the study in a blinded fashion.
| Arm | Type | Receives |
|---|---|---|
| High-dose Psilocybin | Experimental | Drug: Psilocybin 300 mcg/kgPsilocybin 300 mcg/kg once per week, every week, for 8 weeks |
| High- or Low-dose Psilocybin | Experimental | Drug: Psilocybin 100 mcg/kg, Drug: Psilocybin 300 mcg/kgPsilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks |
| High-dose Psilocybin or Lorazepam | Placebo comparator | Drug: Psilocybin 300 mcg/kg, Drug: Lorazepam 1 mgPsilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have moderate to severe OCD (DSM-5) after diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID-R).
- Failed at least one adequate attempted routine care treatment.
- Considered safe for independent living
Key exclusion criteria (7 listed)
- Concurrent psychosis, active substance use disorder, or a personal history of psychosis.
- 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
- Psychiatric comorbidity that may represent an acute risk to their own or others' safety.
- Subjects may not be using antidepressant medication for OCD for at least two weeks before receiving study drug, and they 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.
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 100 mcg/kgAlso: Psilocybine, "magic mushrooms"Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms"). | Drug | High- or Low-dose Psilocybin |
| Psilocybin 300 mcg/kgAlso: Psilocybine, "magic mushrooms"Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms"). | Drug | High- or Low-dose Psilocybin, High-dose Psilocybin, High-dose Psilocybin or Lorazepam |
| Lorazepam 1 mgAlso: Ativan, IntensolA medication used to treat anxiety belonging to a class of drugs known as benzodiazepines, which act on the central nervous system to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA). | Drug | High-dose Psilocybin or Lorazepam |
Primary outcome
Treatment-phase effects on Obsessive-Compulsive symptom severity
Time frame: weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)
Prospective Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) score comparing each psilocybin dose and active placebo (Lorazepam).
7 secondary outcomes
Acute Incidence of Treatment Emergent Adverse Events
Time frame: At 0, and 24 hours after blinded medication ingestion
Duration of Effects on Obsessive-Compulsive symptom severity
Time frame: Follow-up assessments will be conducted weekly over the phone weekly (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days).
Long Term Incidence and Duration of Treatment Emergent Psychiatric Adverse Events
Time frame: Follow-up assessments will be conducted weekly over the phone (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days).
Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD) assessed by Error-related negativity (voltage) and mid-frontal theta power (time-frequency approach)
Time frame: Baseline, and 9-10 hours after ingestion of study dose 1, 4, and 8.
Prospective Self-Assessment of Depression Symptoms
Time frame: Baseline, 24 hours after each dose during 8 week active phase, and during the follow-up phase (weekly for one month after last dose, monthly for three months beginning 28 days after last dose, and then once at 6 months after last dose.
Prospective Clinician-Rated Assessment of Depression Symptoms
Time frame: Baseline, 4 weeks, 8 weeks, and during the follow-up phase (weekly for one month after last dose, monthly for three months beginning 28 days after last dose, and then once at 6 months after last dose
Changes in functional connectivity: 1) between the Caudate Nucleus (CN) and Orbital Frontal Cortex (OFC); 2) within the default mode network (DMN).
Time frame: Imaging at baseline, and 9-10 hours post ingestion on weeks 1, 4, and 8. YBOCS at baseline and 8 hours after ingestion at weeks 1, 4, and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 17196053Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006 Nov;67(11):1735-40. doi: 10.4088/jcp.v67n1110.
- Derived from this study: PubMed 41825921Moreno FA, Allen KE, Wiegand CB, Dunne R, Prickett JI, Bayze B, Allen JJB. A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive-compulsive disorder. J Psychopharmacol. 2026 May;40(5):837-849. doi: 10.1177/02698811261424214. Epub 2026 Mar 13.
- PubMed Abstract LinkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obsessive-compulsive Disorder (OCD)
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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. This study is not recruiting at the moment.
Francisco A. Moreno, MD principal investigator
Professor of Psychiatry and Associate Vice President, Diversity and Inclusion
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 100 mcg/kg, Psilocybin 300 mcg/kg and Lorazepam 1 mg in people with Obsessive-compulsive Disorder (OCD), run by University of Arizona 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-phase effects on Obsessive-Compulsive symptom severity (time frame: weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300947, which also lists 2 linked publications.
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 30 Aug 2024.