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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 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.

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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.

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

FieldValue
Enrollment Target 1,602 participants
Start Date 2021-03-10
Est. Completion 2024-03-25
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT05966129

The ClinicalTrials.gov registry entry for NCT05966129 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,602 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 236-participant average among 50 other Acute Pain trials with a reported enrollment target (579% higher). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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