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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxymorphone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxymorphone<br>participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed | Drug: Oxymorphone<br>* IV PO<br>* Other names: Oxymorphone IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Impression of Change | PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse) | baseline and 12 hours | 
| Brief Pain Inventory |  | Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Sciatica, Diabetic Neuropathies, Complex Regional Pain Syndromes, Low Back Pain, Neck Pain, Headache, Back Pain, Arthritis, Brachial Plexus Injury (stinger/burner), Chronic Pain, Contractures, Diabetes, Fibromyalgia, Foot Pain, Fracture, Herpes Zoster (shingles), Migraine, Neuropathic Pain, Osteoarthritis, Osteoporosis, Rheumatoid Arthritis, Scoliosis, Nerve pain, Opana, Opioid, Opioid Rotation, Oxymorphone, Morphine, neuropathic, oxycodone