Buprenorphine + Oxycodone for Acute Pain

(EASE Trial)

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Overseen ByD'Ann B Hershel, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different pain treatments for individuals with injuries in at least two body parts. One group will receive the usual pain medication, oxycodone, while the other will try buprenorphine, an opioid medication, to determine which manages pain better after a traumatic injury. Suitable candidates for this trial include those injured in multiple areas who are not already using high doses of opioids or specific medications at home. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using buprenorphine or methadone at home, or if you use more than 45 MME of opioids per day.

What is the safety track record for buprenorphine and oxycodone?

Research has shown that buprenorphine is generally safe and effective for treating sudden pain. Studies have found that it eases pain effectively and causes fewer side effects than other opioids. Some individuals have reported sleepiness or drowsiness at higher doses, but overall, buprenorphine is considered safe.

Oxycodone, another opioid commonly used for pain relief, is known for its effectiveness. However, it can cause side effects such as nausea, dizziness, or constipation. Its safety has been well-studied over time.

Both medications help manage pain, but buprenorphine might be safer due to its tendency to cause fewer side effects. Always consult a healthcare professional to determine the best option.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for acute pain, which typically involves opioids like oxycodone, the investigational treatment uses buprenorphine. Buprenorphine is unique because it partially activates opioid receptors, which may lead to effective pain relief with potentially fewer side effects and a lower risk of dependency. Researchers are excited about this treatment because it offers a promising alternative that could enhance patient safety while still effectively managing acute pain.

What evidence suggests that this trial's treatments could be effective for acute pain?

This trial will compare the effectiveness of buprenorphine and oxycodone in managing acute pain. Studies have shown that buprenorphine effectively manages sudden pain and significantly reduces pain compared to other painkillers. Some research even suggests it provides quicker pain relief and is safer than traditional painkillers. For individuals already taking opioids, buprenorphine might help lessen pain, making it a promising option for those needing relief from injuries.25678

Who Is on the Research Team?

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Matthew Painter, MD, FACS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 who have injuries to at least two body areas. People can't join if they use high-dose opioids or certain medications at home, are pregnant, prisoners, non-English speakers, unable to consent, allergic to study drugs, very confused on arrival (unless it improves), or have severe liver disease.

Inclusion Criteria

I am an adult with injuries to at least two different body areas.

Exclusion Criteria

I take more than 45 mg of morphine or its equivalent in opioids each day at home.
I am currently taking buprenorphine or methadone at home.
My alertness improved to normal within 24 hours of hospital admission.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either buprenorphine or oxycodone as part of a multimodal pain control regimen

2 weeks
Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opiate use

2 weeks
1 visit (in-person), additional virtual check-ins

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine
  • Oxycodone

Trial Overview

The study compares the effectiveness and safety of two pain medicines—buprenorphine and oxycodone—for treating sudden pain after traumatic injury. Participants are randomly assigned to receive one of these treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Study groupExperimental Treatment1 Intervention
Group II: Control groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Buprenorphine for acute post-surgical pain - PMC

The overall pool prevalence of pain reduction was noted as 6.2% at different time duration with significant heterogeneity of 100%. Buprenorphine transdermal and ...

Buprenorphine versus full agonist opioids for acute ...

Conclusions Buprenorphine demonstrated superior efficacy in managing acute postoperative pain compared with FAOs, with a favorable safety profile and longer ...

Buprenorphine Significantly Reduces Postoperative Pain ...

Buprenorphine demonstrated significantly lower mean pain intensity scores (Hedges ց, -0.36; 95% CI, -0.59 to -0.14; P <.001) compared with all ...

From Addiction to Acute Pain Relief: A Narrative Review on ...

Conclusion. Buprenorphine represents a promising alternative to full opioid agonists for pain management, particularly in acute settings. Future research is ...

Evidence gap for acute pain outcomes in opioid use disorder

Studies involving individuals already on buprenorphine showed that continuing the agent during episodes of acute pain may reduce pain severity.

Efficacy and safety of sublingual buprenorphine in managing ...

Most of the studies showed that the use of SL buprenorphine led to either better or comparable pain scores when compared to a control group with lesser or ...

Buprenorphine May Be Safe, Effective for Acute Pain in ...

Results from our analysis suggest that buprenorphine may be useful and safe for the treatment of acute pain in older adults. Limitations of ...

The Effectiveness and Safety of Buprenorphine in Palliative ...

Buprenorphine is increasingly used for pain relief in palliative care settings due to its potent analgesic properties, favorable safety profile, and lower risk ...