CLINICAL TRIAL

Oxycodone for Spinal Cord Injuries

Recruiting · 18+ · All Sexes · Charlestown, MA

This study is evaluating whether a placebo pill can help reduce the amount of pain medication needed for individuals with spinal cord injuries.

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About the trial for Spinal Cord Injuries

Eligible Conditions
Burn Injuries · Multiple Trauma · Polytrauma · Spinal Cord Injuries · Wounds and Injuries · Burns

Treatment Groups

This trial involves 2 different treatments. Oxycodone is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Placebo
DRUG
Oxycodone
DRUG
Essential Oil
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Oxycodone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The study examined the feasibility and safety of using exoskeletons in men and women with traumatic or non-traumatic SCI who are participating in the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital. show original
At Spaulding Rehabilitation Hospital, we have a Comprehensive Rehabilitation Program for patients with SCI, polytrauma, or burn injuries show original
People who have neuropathic pain that is above the level of the lesion and/or nociceptive pain that is moderate or severe in nature. show original
per day is recommended to minimize respiratory depression and Narcotic usage of no more than 120 mg of morphine equivalent per day is recommended to minimize respiratory depression, coma, and death. show original
for inpatient rehabilitation following an ABI should be seen by a physiatrist within two weeks of admission If you have suffered a brain injury and need inpatient rehabilitation, you should be seen by a physiatrist within two weeks of admission. show original
The patient is stable and does not have any respiratory or hemodynamic problems. show original
With current narcotic use for pain control
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1 and Day 6
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 1 and Day 6
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 and Day 6.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Oxycodone will improve 1 primary outcome and 6 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 days.

Morphine Equivalent Dose Conversion (MEDC)
6 DAYS
The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. For drug utilization, there is a need to present usage data consistently, considering dosing requirements. One method of representing opioid use at the population level is through the application of Defined Daily Doses (DDD), however, this represents a problem partly because opioids require highly individualized dosing and need to be titrated to pain response, rather than having standard therapeutic dose ranges. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.
6 DAYS
Spinal Cord Injury - Quality of Life measurement system (SCI-QOL)
DAY 1 AND DAY 6
This measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. For the purpose of this research, the Pain Behavior subdomain will be the primary component of this scale to be used. This 7-item fixed-length scale measures manifestations of pain. These actions or reactions can be verbal or non-verbal and involuntary or deliberate. They include observable displays, and verbal reports of pain. This scale includes a small subset of the Patient-Reported Outcomes Measurement Information System (PROMIS ) Pain Behavior item bank (i = 4) and three new items.
DAY 1 AND DAY 6
Numerical Opioid Side Effects (NOSE)
DAY 1 AND DAY 6
Opioid therapy may be associated with adverse effects-which may affect the patient's perception of the overall satisfaction with opioid therapy. The Numerical Opioid Side Effect (NOSE) assessment tool is a simple, rapid, self-administered instrument which has the potential to be utilized in a busy pain clinic setting in efforts to document and longitudinally follow trends of opioid adverse effects.
DAY 1 AND DAY 6
Electroencephalography
DAY 1 AND DAY 6
Electroencephalography (EEG) is an electrophysiological monitoring method to record the electrical activity of the brain. Quantitative electroencephalography (qEEG) stands out as a valuable, non-invasive tool because it provides reliable and relevant information about brain functioning during rest, sensory stimulation, and cognitive tasks. Besides, this technique is safe, low-cost, and employs a straightforward methodology, making it an appropriate tool for clinical practice. EEG at rest and during pain processing event-related potentials (ERP's) at the patient's bedside. The EEG and ERP recordings will be processed for analytical purposes by the investigators will explore standard EEG metrics (e.g., spectral analysis, connectivity, source localization). At the same time, ERPs will provide information related to pain and values of valence and arousal.
DAY 1 AND DAY 6
Modified Brief Pain Inventory (BPI)
DAY 1 AND DAY 6
The BPI is a short self-assessment questionnaire that provides information on various dimensions of pain including how pain developed, the types of pain a patient experiences, and time of day pain is experienced, as well as current ways of alleviating pain. The BPI also consists of the VAS Pain scale, a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring a patient' worst pain and least pain, on average and at present time. The Brief Pain Inventory provides information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension).
DAY 1 AND DAY 6
Metabolomics assessment
DAY 1 AND DAY 6
Metabolomics is the large-scale study of small molecules, commonly known as metabolites, within cells, biofluids, tissues, or organisms. Collectively, these small molecules and their interactions within a biological system are known as the metabolome. The analysis will focus on pathways associated with cognitive and cellular metabolism, metabolites such as indole-3 propionic acid, tryptophan, serotonin, kynurenine, and tyrosine will be analyzed, seeking for alteration associated with cognition. In contrast, uric acid, xanthine, tyrosine, kynurenine, and tryptophan will provide energetic efficiency information. The investigators will collect samples by pinprick system, and analysis will be done using liquid chromatography (LC) technique and by employing Electrochemical Array Detection (ECA).
DAY 1 AND DAY 6
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Who is running the study

Principal Investigator
R. D. Z.
Ross D. Zafonte, MD
Spaulding Rehabilitation Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get spinal cord injuries a year in the United States?

There are approximately 6500 cases of spinal cord injuries per year in the United States, making it the third most common traumatic injury. While this injury is most common in young adults with a peak incidence rate in those 18- to 29-year-old females, it also presents in all age groups. The average admission rate is 15.9 per 1,000. Most spinal cord injuries occur in motor vehicle accidents, accounting for more than 70% of cases. Patients who are admitted suffer from a median time to surgical intervention of around 24 hours, longer than that of patients who go directly to an emergency room.

Anonymous Patient Answer

What causes spinal cord injuries?

Traumatic spinal cord injuries can have different causes, including motor vehicle accidents. Spinal cord injuries are typically a result of an accident or fall, though accidents can affect babies too young to be awake for a fall - therefore impacting those with a younger age range.

Anonymous Patient Answer

What is spinal cord injuries?

Spinal cord injuries were found to be very common among the elderly, about 1 in 7,000 was found suffering from a spinal lesion. They accounted for a greater than 100,000-year-long life expectancy. Spermatic cord trauma was the most common type of traumatic injury. The incidence was low for cervical cord injuries and high for thoracic injuries. The mortality rate was higher for cervical injuries than thoracic injuries. Most spinal cord injuries occur in men, but the mortality rate is very high.

Anonymous Patient Answer

What are common treatments for spinal cord injuries?

Treatment for spinal cord injuries almost invariably involves [pain management](https://www.withpower.com/clinical-trials/pain-management) and immobilization or bracing. Most patients can expect to make a full recovery with medical care and occupational therapy. People who have spinal cord injuries and continue to have leg and/or arm pain often cannot receive adequate medical attention without a proper evaluation. Most need repeated exams and surgeries to repair spinal cord compression. The first important step in evaluation and treatment is to determine the level and type of injury and to pinpoint painful areas. Treatment requires that the surgeon and/or therapist work in close collaboration. Treatments include medical and surgical procedures such as manipulation, biopsies, decompression, implantation of epidural or facet screws, or microdiscectomy.

Anonymous Patient Answer

What are the signs of spinal cord injuries?

Spinal cord injuries typically cause bowel and bladder disturbances, loss of sensation, decreased motor function, and paralysis. Physicians can identify these changes using non-invasive measurements.

Anonymous Patient Answer

Can spinal cord injuries be cured?

All patients can regain and maintain the ability to walk. As a patient with a spinal cord injury reaches older age, care to prevent complications such as pressure sores, deconditioning, and urinary tract and pulmonary infections become increasingly difficult.

Anonymous Patient Answer

How does oxycodone work?

Oxycodone is a prodrug that rapidly decays to oxymorphone upon enzymatic action of esterases (FMO3 in the kidney and the CYP3A4 in the liver) in the intestines, with minimal first-order metabolism. FMO3 is also present in the blood-brain barrier and may therefore also absorb oxymorphone, which can be converted to (1S,(Z)-)-oxymorphone. The effect of oxymorphone on mu opioid receptors in the brain and spinal cord is different in the central (i.e., spinal cord) and autonomic nervous system, leading to unique analgesic effects and side effects.

Anonymous Patient Answer

What is the average age someone gets spinal cord injuries?

For people who are diagnosed with spinal cord injury, about 1 out of 3 of them were between the ages of 25-44, and about 1 out of 3 of them were between the ages of 15-24. This is consistent with the idea that younger persons are more likely to get a spinal injury in sports (e.g. soccer). Older persons tend to have an injury resulting from some other event, such as an automobile accident. This is known as a secondary injury. For example, if someone is hitting their head and has a vehicle in front of them, their spinal cord injury could be caused simply because they were already injured at the time of the vehicle crash.

Anonymous Patient Answer

What are the common side effects of oxycodone?

The most common side effects of oxycodone are dizziness, nausea, drowsiness, abnormal sleep patterns, sweating, dry mouth and constipation. The risk of experiencing side effects is greatly dependent on the dosage of oxycodone prescribed. People who are receiving care from a pain specialist, such as a rheumatologist, or who have a high probability of developing opioid tolerance can be at higher risk of experiencing side effects from the use of oxycodone. The risk of experiencing side effects also varies from person to person.

Anonymous Patient Answer

Who should consider clinical trials for spinal cord injuries?

Clinical trials could benefit SCI patients with some of the following criteria:\nThis survey has limitations inherent in its generalisability. It does not address the problem of lack of awareness among patients suffering from disabling neurological disorders due to lack of available data about this clinical domain. A questionnaire survey may nevertheless be a tool to measure patient's view on clinical trials. We need further work before being able to offer a clear recommendation about the need to conduct clinical trials in this group of patients.

Anonymous Patient Answer

What is the primary cause of spinal cord injuries?

The primary cause of spinal cord injuries may be a traumatic injury or an underlying disease such as polio. In some cases the exact cause cannot be determined. [A]nother [cause] may be an idiopathic (that is, of unknown cause) injury, such as an accidental injury. [Possible other causes] include spinal disc herniation, chronic infection, congenital defects such as muscular dystrophy, or cancer.

Anonymous Patient Answer

Is oxycodone typically used in combination with any other treatments?

Patients with a SCI treated with oxycodone alone generally experienced greater improvements with pain relief or function compared with treatment with any other opioid. Oxycodone treatment combined with other treatments was associated with improvement in pain relief and function.

Anonymous Patient Answer
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