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NCT05966129 · ClinicalTrials.gov registry record · NA
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
A NA study of Acute Pain, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 1,602
- Enrollment target
- 11
- Study locations
NCT05966129: Completed NA study of Acute Pain, sponsored by Duke University.
NCT05966129 is a NA study of Acute Pain that has completed, run by Duke University. The registered enrollment target is 1,602 participants, above the 236-participant average among 50 other Acute Pain trials with a reported enrollment target (579% higher). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05966129, a NA study of Acute Pain, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,602 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
A composite measure of pain and opioid usage, the Silverman Integrated Analgesic Assessment (SIA) score, at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. The SIA has a total score range of -200 to 200, where a higher score corresponds with higher pain and opioid use.
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 |
What the finished NCT05966129 record still lists
NCT05966129 is an interventional study that assigns participants to a tested intervention. Its 1,602 participants enrollment target places it among the larger protocols in the corpus, above the 236-participant average among 50 other Acute Pain trials with a reported enrollment target (579% higher).
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.
NCT05966129 lists 11 locations in 7 states (Florida, Tennessee, Delaware).
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.
What interventions are being tested in trial NCT05966129?
The interventions under investigation include: Pharmacogenetic testing (OTHER), Clinical decisions support (OTHER).
Who is sponsoring clinical trial NCT05966129?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05966129's enrollment target sits among peer trials
1,602 2nd of 50 the highest of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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