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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00488969
First received: June 19, 2007
Last updated: July 24, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Spinal Cord Injury
Drug: Modified-release morphine sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Pain severity (rated using a 0-10 Numeric Rating Scale [NRS]) [ Time Frame: Average of daily ratings over 14 days ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Daily ]
  • Short McGill Pain Questionnaire (modified) (SF-McGill) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Opioids cognitive effects scale [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Patient Generated Index for activity (PGI) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period) ]
  • Daily number of attacks of paroxysmal pain [ Time Frame: Daily ]
  • Allodynia, hyperalgesia, and temporal summation (determined using quantitative sensory testing) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period) ]
  • Concomitant medication usage [ Time Frame: daily ]
  • Subject global impression of change [ Time Frame: two times during the 14 week study period (at the midpoint of each 7-week drug or placebo period ]
  • Short-Form 36 (SF-36) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Positive And Negative Affect Schedule (PANAS) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Brief Patient Health Questionnaire (PHQ-9) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Multidimensional Pain Inventory Life Interference subscale (MPI-LIS) [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Sleep interference assessment [ Time Frame: at randomization and at the midpoint of each 7-week drug or placebo period ]
  • Medication quantity effective for analgesia or maximally tolerated [Time Frame: [ Time Frame: two times during the 14 week study period (at the midpoint of each 7-week drug or placebo period)] ]

Estimated Enrollment: 48
Study Start Date: July 2007
Detailed Description:

Neuropathic pain occurs as a result of damage to neural tissue either in the peripheral or in the central nervous system. Three types of neuropathic pain after SCI are especially difficult to treat: at level central pain (ALCP), at level radicular pain (ALRP), and below level central pain (BLCP). Various analgesic medications with distinct mechanisms and sites of action are currently used in clinical practice for treatment of neuropathic pain after SCI, including antidepressants, anticonvulsants, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. These analgesic medications, when evaluated in animal models of SCI pain and in the treatment of other neuropathic pain states, have been shown to have only modest pain reducing effect. This modest effect is seen clinically as the majority of persons with SCI receiving these drugs continue to experience pain, which is severe and disabling in one third of cases.

This study proposes to examine the efficacy of oral modified release morphine in reducing pain in persons with neuropathic pain after SCI who have not adequately responded to other oral pharmacologic, psychologic, or physical interventions. Only subjects who have failed prior pain treatment regimes will be enrolled. Failure of pain regimen is defined as the presence of pain in spite of medication(s) or other pain treatment, such as biofeedback or other psychological or physical therapy interventions prescribed by a physician.

The following hypothesis will be tested: morphine, when added to non-opioid medications, is more effective than placebo in reducing pain and increasing activity and subjective well-being, in persons with ALCP, ALRP and BLCP. In order to test this hypothesis, a randomized, double blind, placebo-controlled, two period cross-over trial is proposed, during which subjects with ALCP, ALRP, and BLCP will receive daily placebo or modified release morphine while being closely monitored and assessed for: (1) adverse effects, (2) quality and intensity of pain, (3) intensity of allodynia and hyperalgesia, and (4) activity levels and well-being.

All subjects whether assigned to the placebo or active drug will be able to continue any previously prescribed or non-prescribed (over-the-counter) non-opioid medication that has been taken on a regular basis, without dose change, for at least three weeks prior to study entry. These medications may include but are not limited to the analgesics: acetaminophen and any non-steroidal anti-inflammatory drugs; local anesthetics- topical patches such as the lidocaine patch or otherwise; and adjuvant pain medications of the anti-depressant or anticonvulsant classes. Subjects will not be allowed to take any opioid medication, including non-opioid-opioid combination analgesics, other than the study drug for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488969

Contacts
Contact: Anousheh Behnegar, MD 212-659-9379 Anousheh.Behnegar@mountsinai.org
Contact: Jeanne M Zanca, PhD, MPT 212-659-9349 Jeanne.Zanca@mountsinai.org

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Thomas Bryce, MD         
Sub-Investigator: Anousheh Behnega, MD         
Sub-Investigator: Howard Choi, MD         
Sub-Investigator: Marcel Dijkers, MD         
Sub-Investigator: Steven Flanagan, MD         
Sub-Investigator: Wayne Gordon, MD         
Sub-Investigator: Kristjan Ragnarsson, MD         
Sub-Investigator: Adam Stein, MD         
Sub-Investigator: Jeanne Zanca, PhD, MPT         
Sponsors and Collaborators
Mount Sinai School of Medicine
U.S. Department of Education
Investigators
Principal Investigator: Thomas Bryce, MD Mount Sinai School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00488969     History of Changes
Other Study ID Numbers: H133N060027, GCO # 90-135
Study First Received: June 19, 2007
Last Updated: July 24, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Morphine
Chronic Pain
Spinal Cord Injury
Neuropathic Pain

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014