A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

Participation in BACK002, with outcome measures that showed: a low Mystical Experience Questionnaire (MEQ) score, OR a small (or negative) Hospital Anxiety and Depression Scale (HADS) change score, OR a last HADS score that was 11 or greater, OR who have experienced a recurrence in their symptoms of anxiety or depression since completing the 6 month follow-up

A diagnosis of metastatic solid tumor, or incurable hematologic malignancy that has been accepted by a physician in a medical record

Measurable disease is not required

Previous treatment with chemotherapy: There are no minimum or maximum prior lines of chemotherapy

18-85 years of age

Required performance status, including the appropriate scale. Eastern Cooperative Oncology Group (ECOG) 0-2

Hematocrit \> 20

Platelets (Plt) \> 20K

Liver function tests 1.5 x normal

Creatinine 1.5 x normal

Subjects of childbearing potential must be willing to use an effective contraceptive method from study enrollment until at least 1 month after receiving the investigational agent(s)

Must be at least 4 weeks after surgery or radiotherapy at study entry, but can be receiving oral or intravenous (IV) chemotherapy if those schedules can be adjusted around the medication session date

Motivated to participate in a group study and able in the research team's judgment to participate in the small group effectively

On pre-enrollment screening tests, they will have clinically significant anxiety or depressive symptoms as defined by a score of 11 or greater on the HADS-Total

English speaking - able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent. This is a pilot study, and if future larger studies are designed, consideration will be given for non-english-speaking subjects

Must be willing to sign a medical release for the investigators to communicate directly with their treating clinicians (mental health professional or oncologist) and doctors to confirm a medication and/or medical history

Must provide at least one adult who is in contact with the participant at least once a day when the participant is at home for the first day after returning home who is able to verbally monitor participant-reported changes in the behavior and able to notify research staff of behavior changes that may require research staff assessment

(In BACK002, participants were required to taper off selective serotonin reuptake inhibitors \[SSRIs\] in this study they will be allowed to continue.) Must provide a review of any SSRI use since completing BACK002

Must avoid taking any psychiatric medications or starting a new psychiatric medication during the study. Should participant's doctor recommend starting a new psychiatric medication, participant will be required to notify the study team and the subject would withdraw from the study. (Use of as needed \[prn\] benzodiazepines is allowed but high dose chronic benzodiazepine use must be reviewed by the principal investigator \[PI\]. Use of prn gabapentoids is allowed but high dose chronic gabapentoid use must be reviewed by the PI.)

Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the research team in the event that the participant becomes suicidal

If the potential participant is of childbearing potential, they must have a negative pregnancy test at baseline and prior to the medication dosing session, and must agree to use adequate birth control

Are willing to commit to preparation sessions, medication dosing sessions, integration sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts

Must have had serum lab tests within 1 week of the retreat showing values for potassium (K), magnesium (Mg), and calcium in the normal range. (Electrolyte repletion and rechecking of serum labs is allowed to establish eligibility.)

What this study is about