Opioid Use DisorderPhase 4EASENCT07435077
Examining Analgesic Synergy and Efficacy in Trauma Care
A Phase 4 study testing Buprenorphine and Oxycodone in people with Opioid Use Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Buprenorphine and Oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with injury to at least 2 body locations as defined by Abbreviated Injury Scale (AIS) scores (Head, Face, Neck, Chest, Abdomen/Pelvis, Spine, Upper Extremity, Lower Extremity, External)
Who cannot join
- Glasgow Coma Scale (GCS) <15 - Patients may be included if their GCS improves to 15 within 24 hours of admission
- Age <18 years
- Age ≥80years
- Prisoners
- Pregnant patients
- Non-English speakers
Show all 12Show fewer
- Inability to provide consent
- Home buprenorphine or methadone use
- Home opioid use >45 Morphine Milligram Equivalents (MME)/day
- Allergy to any medication within the study or control arm
- Patients undergoing treatment for alcohol withdrawal
- History of cirrhosis requiring dose adjustment of Tylenol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
D'Ann B Hershel, MS, 336-716-1659, Dann.Hershel@wfusm.edu
About this study
Official title: Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens
Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Often, acute care for the injured patient requires administration of pain medication for the purposes of acute pain control from injury. The mainstay of treatment for pain control has historically involved opioid pain medication.
Read the detailed description
A different medication which has been used in place of full agonist opioids is a product known as buprenorphine, which was developed in the 1960's. This medication works as a partial agonist/antagonist of the µ opioid pain receptors. It has performed robustly in comparison to full opioid agonist (FAO) medications, and in a recent meta-analysis of this medication, it was responsible for reducing pain, less rescue analgesia use, and similar rates of adverse events in comparison to full opioid agonist therapy. This also concurrently lowered the amount of Morphine Milligram Equivalents (MME) used by the postoperative patients, although the achievement of lower pain scores is the significant finding. These data assert that buprenorphine is more efficacious than FAO in mitigating acute post op pain due to comparable analgesic effect and longer duration of action when compared to many other oral opioids.
This medication has been commonly used in patients with opioid abuse disorder and has shown improvements in specific patient outcome metrics when induction therapy is performed in hospital for patients with opioid use disorder (OUD). Further, continuation of buprenorphine for patients taking the medication as an outpatient for acute pain control has been shown to be safe, and to have similar efficacy to discontinuation in favor of standard pain regimen therapy.
- Conditions
- Opioid Use Disorder
- Being tested
- Buprenorphine, Oxycodone
- Keywords
- Acute Pain, Pain Control, Trauma Care
- Medical subject headings
- Opioid-Related Disorders, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called Buprenex, Suboxone, Subutex
2 mg every 6 hours prn for moderate to severe pain If after 2 doses this is insufficient, switch to 4 mg Q6 hours as needed IV buprenorphine 150 mcg Q6 hours for breakthrough pain
OxycodoneDrug
Also called standard pain regimen - acetaminophen - ketorolac - methocarbamol
1000 mg acetaminophen every 6 hours (unless <60 kg = 15 mg/kg Q6 hours) IV ketorolac 15 mg Q6 hours x 48 hours; Celebrex 200 mg twice a day after 500 mg methocarbamol three times a day If fail conservative study regimens after 24 hours, may switch to a PCA or consider other analgesic regimens (ketamine, epidural, etcetera)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Standard pain control regimen with oxycodone Receives: Drug: Oxycodone |
| Study group | Experimental | Standard pain control regimen with buprenorphine Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Rating Scale (NRS) Pain Scores
The Numeric Rating Scale (NRS) is an 11-point, self-reported measure of pain intensity ranging from 0 ("no pain") to 10 ("worst imaginable pain").
Measured: Day 14
Secondary outcomes (5)
Morphine equivalent measure (MME)
Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine
Measured: Day 14
Number of doses of rescue narcotic
Number of doses of rescue narcotic
Measured: Day 14
Length of hospital stay
Length of hospital stay
Measured: Day 14
Length of Intensive Care Unit stay length of Intensive Care Unit stay
Length of Intensive Care Unit stay
Measured: Day 14
Opiate prescription utilization post hospitalization (as MME)
Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be administered the standard pain control regimen, which uses a combination of pain medications for pain control after injury with oxycodone as one of the components, or the standard pain control regimen with buprenorphine in place of the oxycodone medication. The remainder of the trauma care will be similar between participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Painter, MD, FACS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435077
- Sponsor's protocol ID
- IRB00140421
- Acronym
- EASE
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens
- ClinicalTrials.gov ID
- NCT07435077
- Acronym / sponsor ID
- EASE / IRB00140421
- Conditions
- Opioid Use Disorder
- Keywords
- Acute Pain, Pain Control, Trauma Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Often, acute care for the injured patient requires administration of pain medication for the purposes of acute pain control from injury. The mainstay of treatment for pain control has historically involved opioid pain medication.
Detailed description
A different medication which has been used in place of full agonist opioids is a product known as buprenorphine, which was developed in the 1960's. This medication works as a partial agonist/antagonist of the µ opioid pain receptors. It has performed robustly in comparison to full opioid agonist (FAO) medications, and in a recent meta-analysis of this medication, it was responsible for reducing pain, less rescue analgesia use, and similar rates of adverse events in comparison to full opioid agonist therapy. This also concurrently lowered the amount of Morphine Milligram Equivalents (MME) used by the postoperative patients, although the achievement of lower pain scores is the significant finding. These data assert that buprenorphine is more efficacious than FAO in mitigating acute post op pain due to comparable analgesic effect and longer duration of action when compared to many other oral opioids.
This medication has been commonly used in patients with opioid abuse disorder and has shown improvements in specific patient outcome metrics when induction therapy is performed in hospital for patients with opioid use disorder (OUD). Further, continuation of buprenorphine for patients taking the medication as an outpatient for acute pain control has been shown to be safe, and to have similar efficacy to discontinuation in favor of standard pain regimen therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be administered the standard pain control regimen, which uses a combination of pain medications for pain control after injury with oxycodone as one of the components, or the standard pain control regimen with buprenorphine in place of the oxycodone medication. The remainder of the trauma care will be similar between participants.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: OxycodoneStandard pain control regimen with oxycodone |
| Study group | Experimental | Drug: BuprenorphineStandard pain control regimen with buprenorphine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with injury to at least 2 body locations as defined by Abbreviated Injury Scale (AIS) scores (Head, Face, Neck, Chest, Abdomen/Pelvis, Spine, Upper Extremity, Lower Extremity, External)
Key exclusion criteria (12 listed)
- Glasgow Coma Scale (GCS) <15 - Patients may be included if their GCS improves to 15 within 24 hours of admission
- Age <18 years
- Age ≥80years
- Prisoners
- Pregnant patients
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 |
|---|---|---|
| BuprenorphineAlso: Buprenex, Suboxone, Subutex2 mg every 6 hours prn for moderate to severe pain If after 2 doses this is insufficient, switch to 4 mg Q6 hours as needed IV buprenorphine 150 mcg Q6 hours for breakthrough pain | Drug | Study group |
| OxycodoneAlso: standard pain regimen - acetaminophen - ketorolac - methocarbamol1000 mg acetaminophen every 6 hours (unless <60 kg = 15 mg/kg Q6 hours) IV ketorolac 15 mg Q6 hours x 48 hours; Celebrex 200 mg twice a day after 500 mg methocarbamol three times a day If fail conservative study regimens after 24 hours, may switch to a PCA or consider other analgesic regimens (ketamine, epidural, etcetera) | Drug | Control group |
Primary outcome
The Numeric Rating Scale (NRS) Pain Scores
Time frame: Day 14
The Numeric Rating Scale (NRS) is an 11-point, self-reported measure of pain intensity ranging from 0 ("no pain") to 10 ("worst imaginable pain").
5 secondary outcomes
Morphine equivalent measure (MME)
Time frame: Day 14
Number of doses of rescue narcotic
Time frame: Day 14
Length of hospital stay
Time frame: Day 14
Length of Intensive Care Unit stay length of Intensive Care Unit stay
Time frame: Day 14
Opiate prescription utilization post hospitalization (as MME)
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
Matthew Painter, MD, FACS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine and Oxycodone in people with Opioid Use Disorder, run by Wake Forest University Health Sciences 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 1 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact D'Ann B Hershel, MS (336-716-1659, Dann.Hershel@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (NRS) Pain Scores (time frame: Day 14). 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 28 Oct 2026.