Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT06560658
Eligibility Criteria:
Inclusion Criteria:
* Age 21 or older - Oregon Psilocybin Services Act sets the minimum eligible age of 21.
* Able to attend all study events.
* Able to read and speak fluent English.
* No more than 100 hours of lifetime meditation experience.
* No prior experience of microdosing of a psychedelic substance and no more two macrodose experiences.
Exclusion Criteria:
* A personal or family history of an immediate family member of schizophrenia, psychosis of any kind, mania, or hypomania.
* A current prescription for lithium, antipsychotic, Phase II UGT substrate such as diclofenac or probenecid, or an unwillingness to taper off these or other medications that the study clinicians determine to be a risk for interactions.
* Active suicidal ideations or history of suicide attempts. Passive ideation, such as "I wouldn't mind if I never woke up again" is permissible.
* Uncontrolled hypertension or heart disease.
* Any form of personality disorder.
* Current recreational drug use or any form of substance abuse in the previous six months.
* Pregnancy, plans to become pregnant during the study period, or breast feeding.
* Active cancer treatment.
* Any mental illness that could currently be rated as severe. This includes but is not limited to a PHQ-9 score above 20, GAD-7 score above 14, or their equivalents on comparable scales and acute trauma related symptoms.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06560658
Study Brief:
Protocol Section:
NCT06560658