Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We would like to learn if a medicine called "modified-release morphine sulfate" (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. "Modified-release" means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: U.S. Department of Education
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Age 18 - 65

• Diagnosis of traumatic spinal cord injury

• Neuropathic pain (pain related to the nervous system) rated at least 4 on a 11-point numeric rating scale at the time of screening

• Pain classified as at level radicular pain (ALRP), at level central pain (ALCP) or below level central pain (BLCP).

• Pain that is present regularly for at least 3 months prior to enrollment, in spite of medication or other pain treatment. This pain can be paroxysmal in nature (attacks of pain).

• Ability to understand instructions and reliably provide pain assessments

• Willingness to stop current opioid medications, if any

• If a female with childbearing potential, using an approved method of birth control (intrauterine device (IUD), barrier protection, a contraceptive implantation system or injection (Norplant® or Depo-Provera®), oral contraceptive pills, or celibacy)

Exclusion Criteria:

• A known sensitivity to opioids

• A history of substance or alcohol abuse within the past 2 years

• A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period

• Other chronic pain that cannot be differentiated from ALCP, ALRP, or BLCP

• A history of active cancer, excluding basal carcinoma of the skin, in the past 3 years

• Serum creatinine levels >= 2.5 mg/dl or hepatic (liver) dysfunction with serum ALT, AST, GGT, or total bilirubin >= 3 times the upper limit of normal

• Participation in any drug study in the last three months

• Currently pregnant or breastfeeding