Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent.

2. Participant has been diagnosed with pancreatic cancer.

3. Receiving or within twelve weeks of having received cancer targeted treatment,including surgery, radiation, chemotherapy, immunotherapy, or other cancer targetedtherapy.

4. Age ≥ 18 years.

5. Has moderate to severe anxiety according to the PROMIS Anxiety Short Form 7a and/orPROMIS-29 anxiety module (T-score of > 60).

6. Documented adequate liver function within the screening period.

7. Use of concomitant standard antidepressants targeting anxiety (e.g. SSRIs) ispermitted if dose has been the same for at least 12 weeks prior to study entry andpatient still meets inclusion #5.

8. Women of child-bearing potential and men with partners of child-bearing potentialmust agree to use adequate contraception (hormonal or barrier method of birthcontrol; abstinence) prior to study entry and while receiving study drug. Women ofchild-bearing potential must have a negative urine or blood pregnancy test atscreening. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her treating physician and studystaff immediately.

9. Must be able to read and understand English.

10. Required not to engage in potentially hazardous activities, such as driving a motorvehicle or operating machinery, after receiving a medication dose until the next dayafter a restful sleep (as per recommendations with Spravato).

11. Agrees to abstain from alcohol use while taking study medication.

Exclusion Criteria:

1. Initial cancer diagnosis ≤6 weeks prior to Day 0.

2. Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria fordiagnoses of schizophrenia, bipolar illness, delirium or psychosis.

3. Scores ≥ 10 on the Suicidal Risk Assessment (SRA).

4. History of allergic reactions or hypersensitivity to ketamine.

5. Documented history of severe cardiac insufficiency (NYHA III or IV), with currentlyuncontrolled and/or unstable cardiac or coronary artery disease.

6. Current or recent significant tachyarrhythmia, severe angina, or myocardialischemia, as assessed by a study physician.

7. Documented history of poorly controlled hypertension (Systolic Blood Pressure > 180mmHG or Diastolic Blood Pressure > 100 mmHG twice within a one-month period in lasttwo months), with or without antihypertensives.

8. Women who are pregnant or nursing or expect to become pregnant or start nursingduring the expected trial duration, and women of childbearing potential who refuseto use contraceptives to prevent childbearing.

9. Uncontrolled hypo- or hyperthyroidism, as assessed by a study physician.

10. Diagnosis of dementia.

11. Treatment with monoamine oxidase inhibitor (MAOI) within 14 days of Day 0.

12. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranialand peripheral arterial vessels) or arteriovenous malformation.

13. History of intracerebral hemorrhage.

14. Refusal/inability to comply with inclusion criterion #10 (driving restrictions) andinclusion criterion #11 (alcohol abstinence) during study treatment period.