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A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
NCT05966129 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Pharmacogenetic testing
- OTHER Clinical decisions support
Study Locations (11)
Florida
- University of Florida - Gainesville — Gainesville
- Nemours Children's Health System — Jacksonville
- Nemours Children's Health System — Orlando
Tennessee
- Meharry Medical College — Nashville
- Nashville General Hospital — Nashville
- Vanderbilt University Medical Center — Nashville
Delaware
- Nemours Children's Health System — Wilmington
Indiana
- Indiana University — Indianapolis
New York
- Icahn School of Medicine at Mount Sinai — New York
North Carolina
- Duke University Medical Center — Durham
North Dakota
- Sanford Health — Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,602 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2024-03-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05966129
The ClinicalTrials.gov registry entry for NCT05966129 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions — of which Pharmacogenetic testing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05966129 reports 11 study locations spanning 7 distinct geographic areas — top geographies include Florida, Tennessee, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05966129 about?
NCT05966129 is a clinical study titled "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)". 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 ...
What is the current status of trial NCT05966129?
This trial is currently completed. It is a NA study. The enrollment target is 1,602 participants. The study started on 2021-03-10. Estimated completion is 2024-03-25.
What conditions does trial NCT05966129 study?
This clinical trial studies the following conditions: Acute Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05966129?
The interventions under investigation include: Pharmacogenetic testing (OTHER), Clinical decisions support (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05966129?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05966129 being conducted?
This trial has 11 study locations across Delaware, Florida, Indiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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