N/A
N=1,602
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT05966129 ↗Enrolled (actual)
1,602
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: 10 Day Silverman Integrated Analgesic Assessment (SIA) Score — 1.4; -1.4 score on a scale — p=0.7957
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic testing (Other); Clinical decisions support (Other)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10 Day Silverman Integrated Analgesic Assessment (SIA) Score |
1.4; -1.4 | 0.7957 |
| SECONDARY 10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale |
5.2; 5.1 | 0.8255 |
| SECONDARY Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day |
10.0; 8.9 | 0.9054 |
| SECONDARY 3 Month Prescription Pain Medication Misuse |
38.5; 39.2 | 0.248 |
| SECONDARY 1 Month PROMIS Mobility Score |
40.4; 39.4 | 0.6012 |
| SECONDARY Number of Participants With Opioid Persistence |
24; 21 | 0.7528 |
| SECONDARY Participants With Drug-Gene Concordance |
112; 47 | <0.0001 sig |
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 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.
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
Data sourced from ClinicalTrials.gov (NCT05966129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.