A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Endo Pharmaceuticals
• Treatments: Analgesics, Opioid; Oxymorphone

Criteria

Inclusion Criteria:

• 18 years of age or older.

• Chronic pain of nociceptive, neuropathic, or mixed origin.

• Patients with chronic non-cancer pain.

• Ongoing chronic Opioid treatment with either oral morphine or oxycodone (long term-more than three months and at least a total daily Opioid dose of 60mg morphine or of 30 mg oxycodone).

• Pain of moderate intensity (>= 4, on the numerical scale 0-10) despite ongoing Opioid therapy.

• Non-pregnant, non-lactating women.

• Sufficient language skills to communicate with research staff.

Exclusion Criteria:

• Non-ambulatory patients.

• Clinically significant respiratory, renal, hepatic, or cardiac disease.

• Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probably sleep apnea).

• History of illicit drug or alcohol dependence or abuse, abnormal drug taking/seeking behaviors.

• Sever depression (> 26 on the BDI) or severe anxiety or insomnia requiring chronic daily use of benzodiazepines or hypnotic drugs.

• Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).

• Hypersensitivity to study medication (Oxymorphone).