A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
Completed · Not applicable
Conditions studied: Acute Pain
In brief
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 Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. All three trials were registered on ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was registered under a separate NCT# and NCT04445792 was converted to a screening record per recent guidance on master protocol research programs (MPRPs). This record is specific to the Acute Pain Trial within the ADOPT-PGx protocol. The Acute Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
Key facts
- Study ID
- NCT05966129
- Run by
- Duke University
- People needed
- 1602
- Starts
- 2021-03-10
- Expected to finish
- 2024-03-25
- Last updated by the study team
- 2026-03-19
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nemours Children's Health System — Wilmington, Delaware, United States
- University of Florida - Gainesville — Gainesville, Florida, United States
- Nemours Children's Health System — Jacksonville, Florida, United States
- Nemours Children's Health System — Orlando, Florida, United States
- Indiana University — Indianapolis, Indiana, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Sanford Health — Fargo, North Dakota, United States
- Meharry Medical College — Nashville, Tennessee, United States
- Nashville General Hospital — Nashville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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