INFUSE Morphine Study

Inclusion criteria

• Males or females at least 18 years of age who are patients of San Diego Hospice & Palliative Care or recruited through San Diego Hospice & Palliative Care or the UCSD Center for Pain and Palliative Medicine.
• During the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity.
• Vital signs (BP, HR, RR) within normal range.
• Adequate venous access in both upper extremities.
• A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
• Life expectancy ≥ ten days.
• Decision-making capacity.
• Signed, written IRB-approved informed consent. -

Exclusion criteria

• Known hypersensitivity or history of any toxicity to morphine.
• Morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study.
• Any contraindication to morphine.
• Known hypersensitivity to naloxone.
• Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
• Known allergy to bee or vespid venom.
• Contraindication to IV heparin lock or known hypersensitivity to heparin.
• Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
• Hemoglobin < 10 g/dL.
• Presence of any other medical condition that would present an unacceptable safety risk to the patient.
• Participation in a study of any investigational drug or device within 30 days of enrollment in this study.