Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial

Eligibility Criteria

• 1. Age 18 years or older
• 2. Diagnosis of head and neck cancer
• 3. Receiving chronic opioid therapy (≥ 30 days)
• 4. Active use of opioids within the past 7 days
• 5. Opioid misuse behavior (COMM score ≥ 9/68)
• 6. ECOG performance status ≥ 2/4
• 7. Ability to communicate in English
• 8. Ability to understand and the willingness to sign a written informed consent document.
• 1. Contraindications to, or allergic to, olanzapine
• 2. Current use of any antipsychotic medication (e.g. quetiapine, haloperidol, risperidone, etc.)
• 3. History of OUD or other substance use disorders, except marijuana
• 4. History of formal psychiatric diagnoses (e.g. bipolar disorder, schizophrenia, major depressive disorder, or anorexia nervosa)
• 5. Hepatic insufficiency (defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the highest normal value, or total bilirubin \>1.5 times the highest normal value) within the past month
• 6. History of uncontrolled Diabetes Mellitus or hyperglycemia (fasting ≥ 200 mg/dL) within the past month
• 7. History of seizure disorder or neuroleptic malignant syndrome
• 8. History of cardiac disease (e.g. coronary artery disease, congestive heart failure)
• 9. (Females only) Known pregnancy, as communicated to study personnel by clinicians; females of childbearing potential will receive advice to use methods of contraception per usual care.