A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Status unconfirmed · Not applicable
Conditions studied: Chronic Nociceptive Pain, Neuropathic Pain, Non-cancer Pain
In brief
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.
Key facts
- Study ID
- NCT00945919
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 12
- Starts
- 2009-07-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2009-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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