18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Pain IntensityPrimary· Baseline to 3 months
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).
Group
Value
95% CI
Chronic Pain - Immediate PGx Testing
-0.7
± 2.3
Chronic Pain - Delayed PGx Testing
-0.8
± 2.4
Pain Reduction MagnitudeSecondary· Baseline to 3 months
Ratio of Composite Pain Score at 3 months relative to baseline. Composite pain intensity scores were shifted to range 0-12 and the pain reduction magnitude is reported as the ratio of pain at 3 months relative to pain at baseline using this adjusted scale. Statistical analyses were conducted using the log ratio pain at 3 months relative to pain at baseline. Due to the presence of 0 values in the ratios, the log ratios include a +.5 offset, i.e. log(3-month pain +.5 / baseline pain + 0.5).
Group
Value
95% CI
Chronic Pain - Immediate PGx Testing
-0.1
± 0.4
Chronic Pain - Delayed PGx Testing
-0.1
± 0.5
Number of Participants With Clinically Significant Pain ReductionSecondary· Baseline to 3 months
Clinically significant pain reduction defined as ratio of 3-month composite pain score relative to baseline is \< 0.7, corresponding to a 30% or more improvement in pain scores.
Group
Value
95% CI
Chronic Pain - Immediate PGx Testing
17
Chronic Pain - Delayed PGx Testing
27
Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Secondary· 3 months
The 7-item PROMIS questionnaire assesses the extent to which participant experience prescription pain medication misuse symptoms in the past 3 months using a 5-point Likert scale. Participants are asked if they have had a prescription for pain medication in the last 3 months. If no, the questionnaire is not administered, if yes, the questionnaire is administered. For the completed questionnaires. Raw scores ranging from 7 to 35. Raw scores are converted to T-scores using the PROMIS conversion table, with T-scores ranging 36.3 to 54.1. Higher T-scores reflect greater symptom severity.
Group
Value
95% CI
Chronic Pain - Immediate PGx Testing
40.1
± 4.8
Chronic Pain - Delayed PGx Testing
40.5
± 4.8
Number of Participants With Drug-Gene ConcordanceSecondary· 3 months
Concordance between the participant reported opioid medications at 3 months and CYP2D6 phenotype.
Group
Value
95% CI
Chronic Pain - Immediate PGx Testing
33
Chronic Pain - Delayed PGx Testing
36
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 28 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05966142.