Status:
COMPLETED
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
University of Florida
Conditions:
Acute Pain
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the ...
Detailed Description
Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Acute Pain Trial
- Age ≥ 8 years
- English speaking or Spanish speaking
- Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others
- Exclusion Criteria
- Trial-wide:
- Life expectancy less than 12 months
- Are too cognitively impaired to provide informed consent and/or complete study protocol
- Are institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated)
- Have a history of allogeneic stem cell transplant or liver transplant
- People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial
- Acute Pain Trial
- Undergoing a laparoscopic surgery
- Receiving chronic opioid therapy, defined as use of opioids on most days for \>3 months
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
1602 Patients enrolled
Trial Details
Trial ID
NCT05966129
Start Date
March 10 2021
End Date
March 25 2024
Last Update
June 5 2025
Active Locations (11)
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1
Nemours Children's Health System
Wilmington, Delaware, United States, 19803
2
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
3
Nemours Children's Health System
Jacksonville, Florida, United States, 32207
4
Nemours Children's Health System
Orlando, Florida, United States, 32827