Psilocybin-Assisted Therapy for the Treatment of... — Clinical Trial Details

Participants

Ages

18 – 85

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria:
A diagnosis of metastatic solid tumor, or incurable hematologic malignancy documented by a physician
Measurable disease is not required
No minimum or maximum prior lines of chemotherapy required
18-85 years of age
ECOG performance status 0-2
Hematocrit > 20
Platelets (Plt) > 20K
Liver function tests ≤ 1.5 x normal
Creatinine ≤ 1.5 x normal
Subjects of childbearing potential must agree to effective contraception from enrollment until at least 1 month after dosing
At least 4 weeks post-surgery or radiotherapy at entry; may receive chemo if scheduling can accommodate medication session
Motivated and able to participate effectively in a small group per investigator judgment
Clinically significant anxiety or depressive symptoms on pre-enrolment screening (HADS-Total ≥ 11)
English speaking and able to give written informed consent
Willing to sign medical release for study investigators to communicate with treating clinicians
Must provide at least one adult contact able to monitor and report behavioural changes
Off SSRIs for five half-lives plus 2 weeks prior to dosing
Must avoid initiating psychiatric medications during study; prn benzodiazepines allowed with PI review for high-dose chronic use; prn gabapentinoids allowed with PI review for high-dose chronic use
Willing to attend preparation, dosing, and integration sessions and complete study assessments and calls

Exclusion Criteria:
Untreated brain metastases
Uncontrolled or concurrent illness (e.g., active infection, symptomatic CHF, unstable angina, cardiac arrhythmia) or psychiatric/social situations limiting compliance
Pregnancy, breastfeeding, or intent to conceive/impregnate through 30 days after dosing
Personal or immediate family history of schizophrenia, bipolar disorder, delusional/paranoid disorders, or schizoaffective disorder
Suicidal ideation with a Columbia-Suicidality Severity Rating Scale (C-SSRS) score ≥ 3
Current substance use disorder (reasonable alcohol or marijuana use not meeting SUD may be allowed)
Use of neuroleptics or SSRIs that cannot be tapered (ondansetron allowed for nausea)
Unstable neurological/medical conditions; history of seizures or chronic/severe headaches
High-dose psychedelic use within prior 12 months (psilocybin >2 g dried mushrooms, LSD >200 µg); microdosing allowed but must stop 1 month before entry
Use of tramadol (risk of serotonin syndrome)
Use of MAOIs or known sensitivity to psilocybin/metabolites; concomitant SSRI/SNRI generally contraindicated
Marked baseline QTc prolongation (e.g., QTc > 450 ms) or other torsade risk factors
Concomitant medications that prolong QT/QTc interval

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer