A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

• 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:

• Age of 18 to no upper limit

• 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 3 months of at least a total daily opioid dose of 60 mg 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 probable sleep apnea)

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

• Severe depression (> 26 on the BDI)

• 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).

• Workman compensation, current or pending medical-legal litigation

• Hypersensitivity to study medication (oxymorphone)