Spinal Cord InjuriesPhase 2COLPNCT03906721
Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Intensive Rehabilitation
A Phase 2 study testing Oxycodone and Essential Oil in people with Spinal Cord Injuries and Polytrauma, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Polytrauma, Burn Injury
- What is being tested?
- Oxycodone and Essential Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 1 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D) polytrauma or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital,
- SCI, polytrauma or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and pain of no more 5 years of evolution,
- Patients admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital,
- Who have; above, at, or sub-lesional neuropathic pain and/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average VAS scale score of 4 or greater at time of enrollment),
- Respiratory and hemodynamically stable,
- With current narcotic use for pain control,
- Narcotic usage of no more than 120 mg of morphine equivalent
Who cannot join
- History of alcohol or drug dependence, as self-reported,
- A history of bipolar disorder or psychosis, as self-reported,
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding,
- Current usage of narcotic medication with dosage higher than 120 mg of morphine equivalent or 80 mg of a short-acting oxycodone,
- Current use of ventilator,
- Compromised medical status due to uncontrolled pathology such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardises patient's participation to the study
- Pregnancy or breastfeeding. Females in childbearing age who are eligible to participate in the study, will be tested for pregnancy by serum hCG test
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries, Polytrauma, Burn Injury, Pain Management
- Being tested
- Placebo, Oxycodone, Essential Oil
- Keywords
- Open-label placebo, Opioids, Conditioning
- Medical subject headings
- Spinal Cord Injuries, Multiple Trauma, Burns, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sugar pill used to condition patients.
OxycodoneDrug
Also called Oxycodone Hydrochloride Tablets
An opioid used for analgesia.
Essential OilOther
An aromatic oil used for conditioning.
| Study group | Role | What they receive |
|---|---|---|
| Conditioning & Open-Label Placebo (COLP) | Experimental | 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. Receives: Drug: Placebo; Drug: Oxycodone; Other: Essential Oil |
| Treatment-as-usual | Other | For the duration of the study, days 1 to 6, oxycodone will be prescribed on a schedule of 3-4 times per day. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Day 1 and Day 6. This outcome measure data represents the change in metabolite concentration from Day 1 (baseline) to Day 6(post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start20 Feb 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized single-blind open-label placebo clinical trial. 60 inpatients will be included from SRH, both men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma and burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital who have; above, at, or sub-lesional neuropathic pain and/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average VAS scale score of 4 or greater at time of enrollment). All subjects must meet clinical criteria for the use of opioids as a treatment for pain management.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Leon Morales-Quezada, MD, PhD, Spaulding Rehabilitation Hospital
- Investigators
- Ross D Zafonte, DO, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906721
- Sponsor's protocol ID
- 2017P001673
- Acronym
- COLP
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2019
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT03906721
- Acronym / sponsor ID
- COLP / 2017P001673
- Conditions
- Spinal Cord Injuries, Polytrauma, Burn Injury, Pain Management
- Keywords
- Open-label placebo, Opioids, Conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized single-blind open-label placebo clinical trial. 60 inpatients will be included from SRH, both men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma and burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital who have; above, at, or sub-lesional neuropathic pain and/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average VAS scale score of 4 or greater at time of enrollment). All subjects must meet clinical criteria for the use of opioids as a treatment for pain management.
| Arm | Type | Receives |
|---|---|---|
| Conditioning & Open-Label Placebo (COLP) | Experimental | Drug: Placebo, Drug: Oxycodone, Other: Essential OilDays 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. |
| Treatment-as-usual | Other | Drug: OxycodoneFor the duration of the study, days 1 to 6, oxycodone will be prescribed on a schedule of 3-4 times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D) polytrauma or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital,
- SCI, polytrauma or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and pain of no more 5 years of evolution,
- Patients admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital,
- Who have; above, at, or sub-lesional neuropathic pain and/or nociceptive pain (musculoskeletal or visceral) that is moderate or severe in nature (average VAS scale score of 4 or greater at time of enrollment),
- Respiratory and hemodynamically stable,
Key exclusion criteria (7 listed)
- History of alcohol or drug dependence, as self-reported,
- A history of bipolar disorder or psychosis, as self-reported,
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding,
- Current usage of narcotic medication with dosage higher than 120 mg of morphine equivalent or 80 mg of a short-acting oxycodone,
- Current use of ventilator,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSugar pill used to condition patients. | Drug | Conditioning & Open-Label Placebo (COLP) |
| OxycodoneAlso: Oxycodone Hydrochloride TabletsAn opioid used for analgesia. | Drug | Conditioning & Open-Label Placebo (COLP), Treatment-as-usual |
| Essential OilAn aromatic oil used for conditioning. | Other | Conditioning & Open-Label Placebo (COLP) |
Primary outcome
Morphine Milligram Equivalents (MME)
Time frame: 6 days
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.
6 secondary outcomes
Visual Analog Scale for Pain (VAS)
Time frame: Day 6
Spinal Cord Injury - Quality of Life Measurement System (SCI-QOL)
Time frame: Day 1 and Day 6
Numerical Opioid Side Effects (NOSE)
Time frame: Change in NOSE score from Day 1 and Day 6
Electroencephalography - Power Spectrum
Time frame: Power spectrum Change from Day 1 to Day 6
Near-infrared Spectroscopy (NIRS)
Time frame: Day 1 and Day 6
Metabolomics Assessment
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross D Zafonte, DO principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxycodone and Essential Oil in people with Spinal Cord Injuries and Polytrauma, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalents (MME) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.