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

Condition(s) targeted: Pain

Intervention: oxymorphone IV (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mount Sinai School of Medicine

Official(s) and/or principal investigator(s):
Marco Pappagallo, MD, Principal Investigator, Affiliation: Mount Sinai School of Medcine

Overall contact:
Javid Ghandehari, MD, Phone: 212-241-1738, Email: Javid.Ghandehari@mountsinai.org

he 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 swithcing from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Official title: A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone

Study design: Treatment, Open Label, Single Group Assignment

Primary outcome:

Patient Global Impression of Change

Brief Pain Inventory

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Javid Ghandehari, MD, Phone: 212-241-1738, Email: Javid.Ghandehari@mountsinai.org

Mount Sinai School of Medcine, New York, New York 10029, United States; Recruiting
Javid Ghandehari, MD, Phone: 212-241-1738, Email: javid.ghandehari@mountsinai.org
Marco Pappagallo, MD, Principal Investigator

Starting date: November 2007
Ending date: August 2008
Last updated: December 19, 2007