Trial Outcomes & Findings for A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial) (NCT NCT05966129)
NCT ID: NCT05966129
Last Updated: 2025-06-05
Results Overview
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.
COMPLETED
NA
1602 participants
Day of surgery (baseline) to 10 days post surgery
2025-06-05
Participant Flow
This record is specific to the Acute Pain Trial within the ADOPT PGx protocol. It only contains the participants consented to the Acute Pain Trial.
Participant milestones
| Measure |
Acute Pain - Immediate PGx Testing
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
Overall Study
STARTED
|
801
|
801
|
|
Overall Study
COMPLETED
|
645
|
638
|
|
Overall Study
NOT COMPLETED
|
156
|
163
|
Reasons for withdrawal
| Measure |
Acute Pain - Immediate PGx Testing
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
63
|
66
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
26
|
25
|
|
Overall Study
Surgery not completed
|
63
|
69
|
|
Overall Study
Surgery logistics issue
|
2
|
1
|
Baseline Characteristics
Intent to Treat population
Baseline characteristics by cohort
| Measure |
Acute Pain - Immediate PGx Testing
n=801 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing
n=801 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
Total
n=1602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 12.1 • n=176 Participants • Modified Intent to Treat population
|
61.8 years
STANDARD_DEVIATION 13.1 • n=175 Participants • Modified Intent to Treat population
|
62.3 years
STANDARD_DEVIATION 12.6 • n=351 Participants • Modified Intent to Treat population
|
|
Sex: Female, Male
Female
|
116 Participants
n=176 Participants • Modified Intent To Treat population
|
122 Participants
n=175 Participants • Modified Intent To Treat population
|
238 Participants
n=351 Participants • Modified Intent To Treat population
|
|
Sex: Female, Male
Male
|
60 Participants
n=176 Participants • Modified Intent To Treat population
|
53 Participants
n=175 Participants • Modified Intent To Treat population
|
113 Participants
n=351 Participants • Modified Intent To Treat population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=176 Participants • Modified Intent to Treat population
|
6 Participants
n=175 Participants • Modified Intent to Treat population
|
11 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=176 Participants • Modified Intent to Treat population
|
169 Participants
n=175 Participants • Modified Intent to Treat population
|
339 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=176 Participants • Modified Intent to Treat population
|
0 Participants
n=175 Participants • Modified Intent to Treat population
|
1 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=176 Participants • Modified Intent to Treat population
|
3 Participants
n=175 Participants • Modified Intent to Treat population
|
3 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=176 Participants • Modified Intent to Treat population
|
0 Participants
n=175 Participants • Modified Intent to Treat population
|
8 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=176 Participants • Modified Intent to Treat population
|
1 Participants
n=175 Participants • Modified Intent to Treat population
|
2 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
22 Participants
n=176 Participants • Modified Intent to Treat population
|
29 Participants
n=175 Participants • Modified Intent to Treat population
|
51 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · White
|
139 Participants
n=176 Participants • Modified Intent to Treat population
|
134 Participants
n=175 Participants • Modified Intent to Treat population
|
273 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=176 Participants • Modified Intent to Treat population
|
3 Participants
n=175 Participants • Modified Intent to Treat population
|
3 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=176 Participants • Modified Intent to Treat population
|
5 Participants
n=175 Participants • Modified Intent to Treat population
|
11 Participants
n=351 Participants • Modified Intent to Treat population
|
|
Region of Enrollment
United States
|
801 Participants
n=801 Participants
|
801 Participants
n=801 Participants
|
1602 Participants
n=1602 Participants
|
PRIMARY outcome
Timeframe: Day of surgery (baseline) to 10 days post surgeryPopulation: Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75.
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.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=160 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=152 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
10 Day Silverman Integrated Analgesic Assessment (SIA) Score
|
1.4 score on a scale
Standard Deviation 95.9
|
-1.4 score on a scale
Standard Deviation 93.1
|
SECONDARY outcome
Timeframe: 10 days post-surgeryPopulation: Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75.
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.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=168 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=160 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
10 Day Pain Intensity as Measured by the PROMIS Numeric Pain Rating Scale
|
5.2 score on a scale
Standard Deviation 2.2
|
5.1 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Day of surgery (baseline) to 10 days post surgeryPopulation: Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75.
Opioid usage from surgery to 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=160 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=152 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
Post-surgery Opioid Usage, Measured in Milligrams of Morphine Equivalents (MME) Per Day
|
10.0 MME/day
Interval 3.0 to 20.0
|
8.9 MME/day
Interval 3.5 to 18.4
|
SECONDARY outcome
Timeframe: 3 months post surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=93 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=98 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
3 Month Prescription Pain Medication Misuse
|
38.5 T-score
Standard Deviation 3.8
|
39.2 T-score
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 1 month post surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=164 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=161 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
1 Month PROMIS Mobility Score
|
40.4 score on a scale
Standard Deviation 16.6
|
39.4 score on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 3-6 months post-surgery, assessed at 6 monthsPopulation: Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75.
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.
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=153 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=146 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
Number of Participants With Opioid Persistence
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Within 10 days post-surgeryPopulation: Modified intent to treat (mITT) population, consisting of participants who completed their surgery and have a genotypic or phenoconverted CYP2D6 activity score ≤ 0.75.
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
Outcome measures
| Measure |
Acute Pain - Immediate PGx Testing (Modified Intent-to-treat, mITT)
n=176 Participants
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
Clinical decisions support: Prescribing recommendations to the provider based on the pharmacogenetic testing results
|
Acute Pain - Delayed PGx Testing (Modified Intent-to-treat, mITT)
n=175 Participants
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Pharmacogenetic testing: Genetic testing of CYP2D6 and CYP2C19
|
|---|---|---|
|
Participants With Drug-Gene Concordance
|
112 Participants
|
47 Participants
|
Adverse Events
Acute Pain - Immediate PGx Testing
Acute Pain - Delayed PGx Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place