A Depression and Opioid Pragmatic Trial in Pharmacogenetics (ADOPT PGx): Acute Pain Trial

This study description pertains to the ADOPT PGx Acute Pain Trial.The overall ADOPT PGx study was 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 (this study), the Chronic Pain Trial, and the Depression Trial. Participants could enroll in only one of the three trials. Trial-specific outcomes will be compared between participants in the intervention arm and control arms who have an actionable phenotype. Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria were 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). Actionable phenotypes are defined as CYP2D6 intermediate metabolizers (IMs) and poor metabolizers (PMs) (i.e. CYP2D6 activity score ≤ 0.75) for the acute pain trial. This study includes approximately 1,610 participants with planned/elective surgery who are anticipated to start a pain control medication with existing CPIC guidelines after their surgery. ]]>
Inclusion Criteria:Age ≥ 8 yearsEnglish speaking or Spanish speakingElective/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 othersExclusion Criteria:Receiving chronic opioid therapy, defined as use of opioids on most days for >3 monthsTrial-Wide Exclustion Critera:Life expectancy less than 12 months Too cognitively impaired to provide informed consent/assent and/or complete study protocol Institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated) 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 Any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments ]]>
March 2021: First randomizationOct 2023: End of EnrollmentMarch 2024: Primary and Study Completion ]]>