A Phase 1 interventional study of Psilocybin 100 mcg/kg and Psilocybin 300 mcg/kg in Obsessive-compulsive Disorder (OCD), sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by University of Arizona · Phase 1, Interventional, and Treatment
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.
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:
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.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
Psilocybin 300 mcg/kg once per week, every week, for 8 weeks
Drug: Psilocybin 300 mcg/kg
Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks
Drug: Psilocybin 100 mcg/kg · Drug: Psilocybin 300 mcg/kg
Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks
Drug: Psilocybin 300 mcg/kg · Drug: Lorazepam 1 mg
Drug page: Psilocybin
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").
Also known as: Psilocybine, "magic mushrooms"
Drug page: Psilocybin
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").
Also known as: Psilocybine, "magic mushrooms"
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).
Also known as: Ativan, Intensol
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).
Time frame: weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)
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)
Time frame: 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.
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
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.
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)
Prospective Assessment of Error Related brain activity comparing each psilocybin dose and active placebo (Lorazepam).
Time frame: 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).
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
Prospective Assessment of Montgomery-Asberg Depression Rating Scale (MADRS) Score comparing each psilocybin dose and active placebo (Lorazepam).
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).
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.
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.
Plan to share: No
Ran from Jan 2019 to primary completion in Oct 2023, 57 months.
Of 13 phase 1 interventional studies under Obsessive-Compulsive Disorder, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's 57 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psilocybin
Obsessive-Compulsive Disorder →