A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial) (ADOPT PGx)
Acute Pain
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Pharmacogenetic, CYP2D6, CYP2C19
Eligibility Criteria
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
Sites / Locations
- Nemours Children's Health System
- University of Florida - Gainesville
- Nemours Children's Health System
- Nemours Children's Health System
- Indiana University
- Icahn School of Medicine at Mount Sinai
- Duke University Medical Center
- Sanford Health
- Meharry Medical College
- Nashville General Hospital
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Acute Pain - Immediate PGx Testing
Acute Pain - Delayed PGx Testing
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period