A Phase 2 interventional study of Placebo and Oxycodone in Spinal Cord Injuries, Polytrauma and Burn Injury, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Spaulding Rehabilitation Hospital · Phase 2, Interventional, and Treatment
The use of conditioning open-label placebo (COLP) will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.
The investigators will conduct an assessor blind controlled clinical trial, participants in the COLP group will be fully informed about the interventions the participants will be allocated for. As this study is designed to be a proof-of-concept, only an authorized member of the study staff will be conducting the assessments. Suppose the subject has been approved to participate by the treating physician. In that case, the co-investigator will discuss the study's details and answer questions both before and during the first study visit.
Study Design and Flow:
This study contains one experimental arm and one control group. The experiment will run in a parallel design, with each subject having six days of participation. Each group will have evaluations before starting the trial (Baseline) and assessments after the six days of study participation. Subjects will be evaluated using the following tools: Morphine Equivalent Dose Conversion (MEDC); Modified Brief Pain Inventory (BPI); Spinal Cord Injury - Quality of Life measurement system (SCI-QOL); and Numerical Opioid Side Effects (NOSE). The investigators will also record medication changes, side effects, and pain levels as measured by the Visual Analog Scale (VAS) daily for each patient.
For this open placebo- opioid dose reduction study. The investigators will enroll a total of 60 subjects with SCI, polytrauma, and burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and ongoing neuropathic or nociceptive pain. Experimental treatments will take place at either Spaulding Rehabilitation Hospital (SRH). The investigators will coordinate with the appropriate care outlets to ensure that the study's procedures will not interfere with their standard of care at Spaulding. This includes, but is not limited to: physicians, therapists, and nurses working with the patient. The investigators will schedule inpatients as their clinical schedule allows.
After enrollment, subjects will be randomized to receive COLP treatment or to receive standardized opioid dosage.
Oxycodone Intervention and Rescue Medication:
All patients enrolled in this study will receive oxycodone as primary opioid medication for pain control. The treating physician will prescribe a short-acting form of oxycodone 3-4 times per day. The accepted range dosage for this medication will be from 10 to 50 mg PO per day (Q24H), treating physicians will decide the oxycodone dosage to control pain effectively. The investigators expect patients enrolled in this study to take an average of 30-40 mg of oxycodone per day (Q24H).
If a subject requires rescue medication, it will be determined by clinical staff.
Baseline assessments will be performed by the investigators. Subjects on the COLP group will undergo three consecutive days of opioid conditioning paired with taste and odorous placebos (pill and smell), followed by three days of the evoked response phase, where the active opioid medication will be alternated with full placebo dosages to decrease the therapeutic opioid dose by 50%. Females of childbearing age-eligible to participate in the study will be tested for pregnancy using a serum human chorionic gonadotropin (hCG) test.
The treatment regime and schedule for patients in the COLP group will include a short-acting opioid prescribed on a program of 3-4 times per day. This will be considered the active agent for the pharmaco-conditioning intervention; subjects will have access and receive rescue medication if necessary (PRN). Other forms of analgesics (NSAIDs and combos) will be prescribed under the criteria of treating physicians; if combined agents containing opiates are used, a morphine equivalence calculation will be applied.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's enrollment of 20 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Days 1 to 3 will include the acquisition phase where oxycodone will be prescribed on a schedule of 3-4 times per day and paired with open-placebo and smelling the essential oil. Days 4 to 6 will be the evoked phase, and patients will receive full oxycodone dosage on alternating days with open placebo and smelling the essential oil.
Drug: Placebo · Drug: Oxycodone · Other: Essential Oil
For the duration of the study, days 1 to 6, oxycodone will be prescribed on a schedule of 3-4 times per day.
Drug: Oxycodone
Sugar pill used to condition patients.
An opioid used for analgesia.
Also known as: Oxycodone Hydrochloride Tablets
An aromatic oil used for conditioning.
Morphine Milligram Equivalents (MME)
Morphine Milligram Equivalents (MME) are used to standardize opioid exposure by expressing the analgesic potency of different opioids relative to morphine. MME is calculated by multiplying the prescribed opioid dose by the daily frequency of administration and then by an opioid-specific conversion factor. The resulting value is expressed as milligrams of morphine equivalents (mg MME). Values range from 0 mg MME upward, with higher values indicating greater opioid exposure, which has been associated with an increased risk of adverse clinical outcomes.
Time frame: 6 days
Visual Analog Scale for Pain (VAS)
The Visual Analog Scale (VAS) is a measurement tool used to quantify pain intensity. It consists of a 10-point anchored by a minimum value of 0, representing "no pain," and a maximum value of 10, representing the "worst pain imaginable." Patients mark their perceived pain level; higher scores indicate a worse outcome, reflecting greater pain severity or distress. For this outcome, we are reporting the difference in VAS from Day 1 to Day 6.
Time frame: Day 6
Spinal Cord Injury - Quality of Life Measurement System (SCI-QOL)
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.
Time frame: Day 1 and Day 6
Numerical Opioid Side Effects (NOSE)
The Numerical Opioid Side Effect (NOSE) assessment tool is a simple, rapid, self-administered instrument to document and longitudinally follow trends of opioid adverse effects. The NOSE typically assesses 10 common, specific opioid side effects, including nausea, fatigue/drowsiness, constipation, itching, decreased libido, dry mouth, abdominal pain, sweating, dizziness, and urinary retention, with each item rated on this 0-10 scale. Higher values on the NOSE scale represent worst side effects Minimum Score: 0 (indicates no problems with opioid side-effects) Maximum Score: 100 (indicates the worst possible opioids side-effects) The reported outcome is the change in NOSE from Day 1(baseline) to Day 6(post-intervention)
Time frame: Change in NOSE score from Day 1 and Day 6
Electroencephalography - Power Spectrum
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. The EEG recordings will be processed for analytical purposes by the investigators will explore standard EEG metrics (e.g., spectral analysis).
Time frame: Power spectrum Change from Day 1 to Day 6
Near-infrared Spectroscopy (NIRS)
NIRS is a spectroscopic method that uses the near-infrared region of the electromagnetic spectrum. This method is based on near-infrared light absorption fluctuations that depend on concentration changes of the chromophores oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin (HHb). The values are usually expressed in micromolar units (mM) of concentration change relative to a baseline. The higher the O2Hb value, represents higher cortical activity. Higher HHb represents decreased cortical activity. The outcome is reported as the change O2Hb and HHb from Day 1(baseline) to Day 6 (post-intervention)
Time frame: Day 1 and Day 6
Metabolomics Assessment
Metabolomics is the large-scale study of small molecules. The analysis will focus on pathways associated with cognitive and cellular metabolism. 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). Concentration of metabolites will be reported and used for analysis using the absolute quantification value in (micromolar). This outcome measure data represents the change in metabolite concentration from baseline to post-intervention.
Time frame: Day 1 and Day 6. This outcome measure data represents the change in metabolite concentration from Day 1 (baseline) to Day 6(post-intervention)
| Milestone | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Morphine Milligram Equivalents (MME) are used to standardize opioid exposure by expressing the analgesic potency of different opioids relative to morphine. MME is calculated by multiplying the prescribed opioid dose by the daily frequency of administration and then by an opioid-specific conversion factor. The resulting value is expressed as milligrams of morphine equivalents (mg MME). Values range from 0 mg MME upward, with higher values indicating greater opioid exposure, which has been associated with an increased risk of adverse clinical outcomes.
| morphine milligram equivalents | COLP | Treatment-as-usual |
|---|---|---|
| Morphine Milligram Equivalents (MME) | 66 ± 63 | 65.62 ± 53.82 |
The Visual Analog Scale (VAS) is a measurement tool used to quantify pain intensity. It consists of a 10-point anchored by a minimum value of 0, representing "no pain," and a maximum value of 10, representing the "worst pain imaginable." Patients mark their perceived pain level; higher scores indicate a worse outcome, reflecting greater pain severity or distress. For this outcome, we are reporting the difference in VAS from Day 1 to Day 6.
| units on a scale | COLP | Treatment-as-usual |
|---|---|---|
| Visual Analog Scale for Pain (VAS) | 1.2 ± 1.03 | 1.2 ± 1.75 |
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.
No measurements were reported for this outcome.
The Numerical Opioid Side Effect (NOSE) assessment tool is a simple, rapid, self-administered instrument to document and longitudinally follow trends of opioid adverse effects. The NOSE typically assesses 10 common, specific opioid side effects, including nausea, fatigue/drowsiness, constipation, itching, decreased libido, dry mouth, abdominal pain, sweating, dizziness, and urinary retention, with each item rated on this 0-10 scale. Higher values on the NOSE scale represent worst side effects Minimum Score: 0 (indicates no problems with opioid side-effects) Maximum Score: 100 (indicates the worst possible opioids side-effects) The reported outcome is the change in NOSE from Day 1(baseline) to Day 6(post-intervention)
| score on a scale | COLP | Treatment-as-usual |
|---|---|---|
| Numerical Opioid Side Effects (NOSE) | 16.3 ± 12.71 | 27 ± 24.02 |
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. The EEG recordings will be processed for analytical purposes by the investigators will explore standard EEG metrics (e.g., spectral analysis).
No measurements were reported for this outcome.
NIRS is a spectroscopic method that uses the near-infrared region of the electromagnetic spectrum. This method is based on near-infrared light absorption fluctuations that depend on concentration changes of the chromophores oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin (HHb). The values are usually expressed in micromolar units (mM) of concentration change relative to a baseline. The higher the O2Hb value, represents higher cortical activity. Higher HHb represents decreased cortical activity. The outcome is reported as the change O2Hb and HHb from Day 1(baseline) to Day 6 (post-intervention)
No measurements were reported for this outcome.
Metabolomics is the large-scale study of small molecules. The analysis will focus on pathways associated with cognitive and cellular metabolism. 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). Concentration of metabolites will be reported and used for analysis using the absolute quantification value in (micromolar). This outcome measure data represents the change in metabolite concentration from baseline to post-intervention.
No measurements were reported for this outcome.
Collected over Six days, from day 1 (baseline) to day 6 (post-intervention). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COLP | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Treatment-as-usual | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| Mean | 44.90 ± 16.93 | 49.70 ± 16.62 | 47.30 ± 16.51 |
| Sex: Female, Male(Participants) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 10 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 8 | 8 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Conditioning & Open-Label Placebo (COLP) | Treatment-as-usual | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Nov 2021, 32 months.
Results were first posted in Aug 2026, 4 years 9 months after primary completion.
Of 44 non-industry phase 2 interventional studies under Spinal Cord Injuries, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 64. This study's 32 months is below that.
Counting every sponsor, half of 49 studies reached it within 46 months; a quarter within 28 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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