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

CompletedPhase 2NCT00488969
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury
Interventions
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
U.S. Department of Education
Start date
2007-07
Primary completion
2013-07
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00488969