| Eligibility |
Inclusion Criteria:
Are 60-85 years of age at time of Informed Consent Form signing. Are able and willing to
adhere to study requirements, including attending all study visits, preparatory and
follow-up sessions, and completing all study evaluations.
Are able to swallow capsules. Women of childbearing potential (WOCBP) must agree to
practice an effective means of birth control throughout the duration of the study.
Have normal or corrected-to-normal vision as determined by the study staff. Written
informed consent obtained from and ability for subject to comply with the requirements of
the study.
Have an identified support person and agree to be accompanied home (or to an otherwise safe
destination) by the support person, or another responsible party, following dosing.
Agree to inform the investigators within 48 hours of any new or changed medical conditions
during the course of their study participation.
Have access to a quiet space and a computer to perform online assessments.
Exclusion Criteria:
Breastfeeding, have a positive pregnancy test at screening or at any point during the
course of the study, or unwilling to practice birth control during participation in the
study.
Have a current psychiatric disorder, general medical condition, or other problem or
abnormality that, in the opinion of the study clinician or PI, could compromise safety,
render them unsuitable for the study, or would make them unable to comply with study
activities.
Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as
determined by an MRI contraindications questionnaire.
In the baseline C-SSRS, the study clinician records the presence of active suicidal
ideation (SI) with an intent and/or plan or any history within the past year of SI with an
intent and/or plan as indicated by a positive response ("Yes") to Questions 4 or 5 on the
C-SSRS SI questions; or presence of active suicidal behavior or any history within the past
5 years of suicidal behavior including suicide attempt (including actual attempt,
interrupted attempt, or aborted attempt), preparatory acts for suicide attempt, or
non-suicidal self-injurious behavior as indicated by a positive response ("Yes") to any
suicide behavior questions of the C-SSRS.
Have a history of a psychotic disorder, bipolar disorder (type I or II), or a dissociative
disorder (determined by history).
Family history (first degree relative) of primary psychotic disorder, primary bipolar
disorder, or hallucinogen-induced psychotic disorder, if participant < 30 years old.
History of Hallucinogen Persisting Perception Disorder (HPPD). History of a seizure
disorder in adulthood, central nervous system (CNS) metastases or current symptomatic CNS
infection.
History of intracerebral hemorrhage, embolic stroke, transient ischemic attack (TIA), or
history of any aneurysmal vascular disease (including thoracic and abdominal aorta,
intracranial and peripheral arterial vessels) or arteriovenous malformation.
History of valvulopathy or pulmonary hypertension. Uncontrolled hypertension (Systolic
BP>139mmHG or Diastolic BP>89mmHG) or tachycardia (average HR>90bpm) averaged over at least
two measurements.
Clinically significant cardiovascular disease (e.g., history of myocardial infarction or
congestive heart failure); or baseline QT/QTc>500msec; or baseline QT/QTc 451-500msec with
repeat QT/QTc >500msec.
Poorly controlled diabetes mellitus (e.g., history of an episode of severe hypoglycemia or
hospitalization for hyperglycemia on the current diabetes regimen).
Inadequate hepatic function as determined by total bilirubin or alkaline phosphatase >3x
institutional upper limit of normal; or AST or ALT >6x institutional upper limit of normal.
However, participants with Gilbert syndrome are allowed to enroll.
Inadequate renal function as determined by eGFR < 30 mL/min/1.73 m2 (based on the MDRD
equation) or CrCl < 30 mL/min (based on the C-G equation).
The regular use of psychotropic medications, such as antidepressants (i.e., SSRIs,
tricyclic antidepressants, and monoamine oxidase inhibitors), antipsychotics, and mood
stabilizers.
Concomitant dosing of psilocybin with known UGT1A10 and UGT1A9 inhibitors (e.g., diclofenac
and probenecid) will be avoided. [There is no exclusion criterion based on the use of
medications or substances that are inhibitors or inducers of CYP450 enzymes.]
The use of Prohibited Medications:
Serotonin Reuptake Inhibitors (SSRIs and SNRIs) Tricyclic Antidepressants (TCAs) Monoamine
Oxidase Inhibitors (MAOIs) Atypical antidepressants (e.g., mirtazapine, trazodone, buspar)
Antipsychotics/Neuroleptics (typical and atypical) Anti-epileptics or mood stabilizers
(e.g., lithium, valproate) (does not include gabapentin used for non-epilepsy conditions)
Efavirenz (Sustiva, in Atripla) Lorcaserin Over-the-counter supplements intended to affect
mood or anxiety (e.g., 5HT-P, SAMe or St. John's Wort).
Other drugs associated with the serotonin syndrome (e.g., ondansetron) used within 48 hours
of study drug administration.
Vasoactive drugs (e.g., sildenafil, sumatriptan, calcium channel blockers) used within 48
hours of study drug administration.
Unable to agree to the following required Lifestyle Modifications: Patients will be asked
to refrain from consuming alcohol, cannabinoids, prescription
analgesics/stimulants/benzodiazepines, and any recreational drugs for 48 hours before, the
day of, and for 48 hours after study drug administration. Participants will be advised to
consume their usual amount of coffee, tea, or other caffeine-containing beverages on the
morning of their Medication Visits.
Have a recent history of suicidal ideation or attempted suicide that, in the opinion of the
study clinician or PI, may present a risk of suicidal or self-injurious behavior.
Have received an investigational drug or taken a psychedelic, entactogen, or dissociative
anesthetic within 30 days of the screening visit Have taken a psychedelic drug (e.g.,
psilocybin, lysergic acid diethylamide (LSD-25), mescaline) >15 times in last 30 years Have
taken a psychedelic drug (e.g., psilocybin, LSD-25, mescaline) >0 times in last 3 months
Have taken an entactogen (e.g., 3,4-methylenedioxymethamphetamine (MDMA),
3,4-Methylenedioxyamphetamine (MDA)) >15 times in last 30 years Have taken an entactogen
(e.g., MDMA, MDA) >0 times in last 3 months Have taken a dissociative anesthetic (e.g.,
ketamine, Phencyclidine (PCP)) >15 times in last 30 years Have taken a dissociative
anesthetic (e.g., ketamine, PCP) >0 times in last 3 months Have an allergy or intolerance
to any of the materials contained in the investigational drug product.
Has been diagnosed with any disease that impairs motor function (e.g., Parkinson's disease)
At high risk of falls as determined by study physician considering medical history,
screening of recent symptoms and medications, and functional mobility testing.
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