NCT07430345 Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department
| NCT ID | NCT07430345 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The Cooper Health System |
| Condition | Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-05-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if buprenorphine can treat pain in older adults who have broken bones. The main questions it aims to answer are: Is buprenorphine as effective as opioids to treat pain? Are there less side effects with buprenorphine? Researchers will compare buprenorphine and hydromorphone to see if there are differences in pain control and side effects. Participants will be given one of the two study drugs after breaking a bone and asked about their pain scores and side effects for the next 48 hours.
Eligibility Criteria
Inclusion Criteria: * Age 65 years or older * Emergency Department patient * Diagnosis of suspected or confirmed acute fracture * Numerical Rating Scale 4 or greater at time of presentation * Must be able to give informed consent or have a surrogate decisionmaker to provide informed consent * Subjects who may require a surgical procedure are eligible for enrollment, as given the low dose of buprenorphine, this is not anticipated to affect future anesthesia. If additional pain control is needed for surgical procedure, full agonist opioid can be used without contraindication. Exclusion Criteria: * Prior history of opioid use disorder * Participants taking chronic opioid therapy (defined as opioids taken during the past month) * Allergy to study medications * Hemodynamic instability requiring immediate resuscitation * Inability to consent and absence of surrogate decisionmaker
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07430345 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07430345 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07430345 currently recruiting?
Yes, NCT07430345 is actively recruiting participants. Contact the research team at selman-katherine@cooperhealth.edu for enrollment information.
Where is the NCT07430345 trial being conducted?
This trial is being conducted at Camden, United States.
Who is sponsoring the NCT07430345 clinical trial?
NCT07430345 is sponsored by The Cooper Health System. The trial plans to enroll 48 participants.