Trial · NCT05966129
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
NCT05966129, Not applicable, Completed, Duke University; results first posted 2025-06-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial). Trials, record NCT05966129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05966129
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)
- NCT number
- NCT05966129
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,602 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Acute Pain
- Interventions
- Pharmacogenetic testing, Clinical decisions support
- First posted
- 2023-07-28
- Last updated
- 2026-03-19
- Results first posted
- 2025-06-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 10 Day Silverman Integrated Analgesic Assessment (SIA) Score | Day of surgery (baseline) to 10 days post surgery | 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. |
| Secondary | 10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale | 10 days post-surgery | PROMIS (Patient-Reported Outcomes Measurement Information System) Numeric Pain Rating Scale Pain intensity at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. Pain was measured on a scale of 0-10, where higher scores correspond to higher levels of pain. |
| Secondary | Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day | Day of surgery (baseline) to 10 days post surgery | Opioid usage from surgery to 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. |
| Secondary | 3 Month Prescription Pain Medication Misuse | 3 months post surgery | The 7-item PROMIS Prescription Pain Medication Misuse questionnaire assesses the extent to which participants experience medication misuse symptoms over the past 3 months using a 5-point Likert scale. The 7 questions are converted to a raw score, ranging from 7 to 35. Raw scores are converted to T-scores using the PROMIS conversion tables and range from 36.3 to 55.8. Higher scores reflect greater medication misuse. |
| Secondary | 1 Month PROMIS Mobility Score | 1 month post surgery | PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75 in the adult population only. The score ranges from 15 to 75, where a higher score corresponds to higher mobility. |
| Secondary | Number of Participants With Opioid Persistence | 3-6 months post-surgery, assessed at 6 months | Opioid persistence defined as a filled prescription for an opioid medication 3-6 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75. |
| Secondary | Participants With Drug-Gene Concordance | Within 10 days post-surgery | Drug-Gene Concordance defined as an agreement between the Pharmacogenomics (PGx) Test and the prescribed opioids post surgery for pain management in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 10 Day Silverman Integrated Analgesic Assessment (SIA) Score | Day of surgery (baseline) to 10 days post surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75. | score on a scale | MEAN |
| SECONDARY | 10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale | 10 days post-surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75. | score on a scale | MEAN |
| SECONDARY | Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day | Day of surgery (baseline) to 10 days post surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75. | MME/day | MEDIAN |
| SECONDARY | 3 Month Prescription Pain Medication Misuse | 3 months post surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75 who indicated having a prescription for pain medication in the past 3 months. | T-score | MEAN |
| SECONDARY | 1 Month PROMIS Mobility Score | 1 month post surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75 in adults only. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Opioid Persistence | 3-6 months post-surgery, assessed at 6 months | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Drug-Gene Concordance | Within 10 days post-surgery | Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 10 Day Silverman Integrated Analgesic Assessment (SIA) Score | Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) | 1.4 | Standard Deviation 95.9 | score on a scale | |
| 10 Day Silverman Integrated Analgesic Assessment (SIA) Score | Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT) | -1.4 | Standard Deviation 93.1 | score on a scale | |
| 10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale | Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) | 5.2 | Standard Deviation 2.2 | score on a scale | |
| 10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale | Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT) | 5.1 | Standard Deviation 2.3 | score on a scale | |
| Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day | Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) | 10.0 | Inter-Quartile Range 3.0 to 20.0 | MME/day | |
| Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day | Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT) | 8.9 | Inter-Quartile Range 3.5 to 18.4 | MME/day | |
| 3 Month Prescription Pain Medication Misuse | Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) | 38.5 | Standard Deviation 3.8 | T-score | |
| 3 Month Prescription Pain Medication Misuse | Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT) | 39.2 | Standard Deviation 4.5 | T-score | |
| 1 Month PROMIS Mobility Score | Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) | 40.4 | Standard Deviation 16.6 | score on a scale | |
| 1 Month PROMIS Mobility Score | Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT) | 39.4 | Standard Deviation 17.2 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Pain - Immediate PGx Testing | 801 | |
| Overall Study | STARTED | Acute Pain - Delayed PGx Testing | 801 | |
| Overall Study | COMPLETED | Acute Pain - Immediate PGx Testing | 645 | |
| Overall Study | COMPLETED | Acute Pain - Delayed PGx Testing | 638 | |
| Overall Study | NOT COMPLETED | Acute Pain - Immediate PGx Testing | 156 | |
| Overall Study | NOT COMPLETED | Acute Pain - Delayed PGx Testing | 163 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Pain - Immediate PGx Testing | 1 | 801 |
| Total, all-cause mortality | Acute Pain - Delayed PGx Testing | 2 | 801 |
| Total, other adverse events | Acute Pain - Immediate PGx Testing | 0 | 801 |
| Total, other adverse events | Acute Pain - Delayed PGx Testing | 0 | 801 |
| Total, serious adverse events | Acute Pain - Immediate PGx Testing | 0 | 801 |
| Total, serious adverse events | Acute Pain - Delayed PGx Testing | 0 | 801 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HG010225 | The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination | WYATT, CHRISTINA M; CHAKRABORTY, HRISHIKESH | DUKE UNIVERSITY | NATIONAL HUMAN GENOME RESEARCH INSTITUTE | 2018 to 2024 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) vs Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT): Participants With Drug-Gene Concordance | Trial comparisons |
| Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT) vs Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT): Number of Participants With Opioid Persistence | Trial comparisons |
| Acute Pain - Immediate PGx Testing vs Acute Pain - Delayed PGx Testing: deaths from any cause | Trial comparisons |
| Acute Pain - Immediate PGx Testing vs Acute Pain - Delayed PGx Testing: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05966129
GET https://conductscience.org/api/trials/v1/NCT05966129/registered