Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers

Inclusion Criteria

• •Participant aged ≥ 18 years.
• •Participant with non-operable GI cancers requiring multi-modal treatment (e.g. surgery +/- chemo +/-radiation) and have a a high likelihood of recurrence and/or treatment failure in the opinion of the treating investigator.
• •Screen positivity for existential distress on the EDS, defined as scoring ≥ 3 on any of the 10 component domains, or a total score ≥ 6
• •ECOG Performance Status ≤ 2.
• •Adequate hepatic function as defined as:
• •* Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome
• •* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
• •* Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• •For participants of childbearing potential: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• •* Participants \< 50 years of age:
• •* Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• •* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
• •* Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
• •* Participants ≥ 50 years of age:
• •* Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
• •* Had radiation-induced menopause with last menses \>1 year ago; or
• •* Had chemotherapy-induced menopause with last menses \>1 year ago; or
• •* Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
• •Participants of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
• •Participants with a sexual partner of childbearing potential must agree to use a condom during intercourse for 24 hours post- ketamine dose.
• •Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 hours of each ketamine administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication
• •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
• •Agree that for one week preceding the ketamine session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
• •Agree not to use nicotine for at least 2 hours before the ketamine administration or for the duration of the ketamine session.
• •Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the ketamine session. If the participant does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of ketamine administration.
• •Participants requiring opioid use for pain are on a stable pain management regimen or do not experience clinically significant sedation during opioid use. Note: Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 hours before ketamine administration; such medication will not be taken again until at least 6 hours after ketamine administration.
• •Fluent in English.
• •Reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
• •Have a support person who is be able to escort the participant home from the ketamine dosing sessions. Note: The use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.)