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NCT05966142 · ClinicalTrials.gov registry record · NA

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
1,048
Enrollment target

NCT05966142: Completed NA study, sponsored by Duke University.

NCT05966142 is a NA study that has completed, run by Duke University. The registered enrollment target is 1,048 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05966142, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
1,048 participants
Enrollment target

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 Chronic Pain Trial within the ADOPT-PGx protocol. The Chronic 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 opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.

Primary Outcome

The composite pain intensity score is derived from the 3-time PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity scale. Composite pain intensity score is the sum of the 3 questions and ranges from 3 (no pain) to 15 (intense pain). Change in composite pain intensity score ranges from -12 (change from the highest level of pain to the lowest level of pain) to 12 (change from the lowest level of pain to the highest level of pain).

Interventions

  • OTHER Pharmacogenetic testing
  • OTHER Clinical decisions support

Trial Details

FieldValue
Enrollment Target 1,048 participants
Start Date 2021-02-24
Est. Completion 2024-05-10
Phase NA
Duke University

1,725 total trials

What the finished NCT05966142 record still lists

NCT05966142 is an interventional study that assigns participants to a tested intervention. Its 1,048 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Pharmacogenetic testing is the first listed.

NCT05966142 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05966142 about?

NCT05966142 is a clinical study titled "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic 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 NCT05966142?

This trial is currently completed. It is a NA study. The enrollment target is 1,048 participants. The study started on 2021-02-24. Estimated completion is 2024-05-10.

What interventions are being tested in trial NCT05966142?

The interventions under investigation include: Pharmacogenetic testing (OTHER), Clinical decisions support (OTHER).

Who is sponsoring clinical trial NCT05966142?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05966142's enrollment target sits among peer trials

1,048 100th of 2000 higher than 1,901 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05966142, the US trial registry maintained by the National Library of Medicine. NCT05966142 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.