Clinical trial
Psilocybin for Treatment of Obsessive Compulsive Disorder
Name
1707613822
Description
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.
Trial arms
Trial start
2019-01-02
Estimated PCD
2023-10-30
Trial end
2023-12-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Psilocybin 100 mcg/kg
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").
Arms:
High- or Low-dose Psilocybin
Other names:
Psilocybine, "magic mushrooms"
Psilocybin 300 mcg/kg
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").
Arms:
High- or Low-dose Psilocybin, High-dose Psilocybin, High-dose Psilocybin or Lorazepam
Other names:
Psilocybine, "magic mushrooms"
Lorazepam 1 mg
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).
Arms:
High-dose Psilocybin or Lorazepam
Other names:
Ativan, Intensol
Size
15
Primary endpoint
Treatment-phase effects on Obsessive-Compulsive symptom severity
weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Phase One: Double blind (both participant AND researchers (In room Care Provider, Investigators, Blinded Outcomes Assessor) Phase Two: Single blind (Participant and Blinded Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2023-08-03
1 organization
Organization
University of Arizona