A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Information source: Mount Sinai School of Medicine
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Nociceptive Pain; Neuropathic Pain; Non-cancer Pain
Intervention: Oxymorphone ER (Drug)
Sponsored by: Mount Sinai School of Medicine
Official(s) and/or principal investigator(s):
Marco Pappagallo, MD, Principal Investigator, Affiliation: Mount Sinai School of Medicine
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.
Official title: A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: The safety of rapid Opioid rotation
This project will enroll 12 volunteers who suffer from chronic pain. Potential participants
must be on one of the following therapies:
- Long acting morphine
- Oxycodone Participants will be asked to complete a pain diary for approximately 10 days
and to stop taking their current pain medications the night before they are admitted o
the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA
(Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take
approximately a total of 8 hrs. At the end of the titration period, patients will be
discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use.
During the titration, patients' pain, vital and side effects will be assessed hourly
until the 8th hour of the IV PCA titration.
Patients will be contacted daily by a member of the study team to assess pain and side
effects. The OPANA ER dose will be adjusted as needed to adequately manage both.
If patients do not feel as though they are getting adequate pain relief, they can return to
their previous medication, at which point they are considered withdrawn from the study.
Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in
order to assess pain relief. In addition, a final follow-up telephone interview will take
place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians
will ask about your pain treatment and ask which Opioid medication you are currently taking.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Non-pregnant, non-lactating women.
- Sufficient language skills to communicate with research staff.
- 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
- History of illicit drug or alcohol dependence or abuse, abnormal drug taking/seeking
- 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).
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States; Recruiting
Marco Pappagallo, Phone: 212-241-7631, Email: email@example.com
Starting date: July 2009
Last updated: July 23, 2009