An interventional study of Pharmacogenetic testing and Clinical decisions support in Chronic Pain, sponsored by Duke University. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for acute and chronic pain, the challenge is finding effective therapy while minimizing adverse effects or opioid addiction (and the ensuing consequences). For depression, there are few clinically relevant predictors of successful treatment leading to multiple trials of inadequate therapy for some patients. Both opioid and antidepressant prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC).
This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting.
The rationale for examining a genotype-guided approach to acute and chronic pain management is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and hydrocodone and data from a pilot study supporting improved pain control in intermediate and poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline. Similarly, the rationale for examining a genotype-guided approach to depression medication therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19 oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials support the hypothesis of improved depression symptom control in a genotype-guided arm.
Study objectives:
Determine if a genotype-guided approach to pain therapy in participants with at least 3 months of chronic pain leads to improved pain control compared to usual care.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 1,048 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Chronic Pain Trial
Exclusion Criteria
Trial-wide:
Chronic Pain
Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
Other: Pharmacogenetic testing · Other: Clinical decisions support
Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
Other: Pharmacogenetic testing
Genetic testing of CYP2D6 and CYP2C19
Prescribing recommendations to the provider based on the pharmacogenetic testing results
Change in Pain Intensity
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).
Time frame: Baseline to 3 months
Pain Reduction Magnitude
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).
Time frame: Baseline to 3 months
Number of Participants With Clinically Significant Pain Reduction
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.
Time frame: Baseline to 3 months
Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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.
Time frame: 3 months
Number of Participants With Drug-Gene Concordance
Concordance between the participant reported opioid medications at 3 months and CYP2D6 phenotype.
Time frame: 3 months
This record is specific to the Chronic Pain Trial within the ADOPT PGx protocol. It only contains the participants consented to the Chronic Pain Trial.
| Milestone | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Started | 527 | 521 |
| Completed | 456 | 457 |
| Not completed | 71 | 64 |
| Withdrew: Death | 3 | 3 |
| Withdrew: Lost to follow-up | 55 | 52 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 8 |
| Withdrew: Duplicate enrollment | 1 | 0 |
| Withdrew: Study logistical reason | 1 | 0 |
| Withdrew: Unable to complete follow up due to change in health | 1 | 1 |
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).
| score on a scale | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Change in Pain Intensity | -0.7 ± 2.3 | -0.8 ± 2.4 |
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).
| log ratio | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Pain Reduction Magnitude | -0.1 ± 0.4 | -0.1 ± 0.5 |
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.
| Participants | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Number of Participants With Clinically Significant Pain Reduction | 17 | 27 |
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.
| T-score | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 40.1 ± 4.8 | 40.5 ± 4.8 |
Concordance between the participant reported opioid medications at 3 months and CYP2D6 phenotype.
| Participants | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing |
|---|---|---|
| Number of Participants With Drug-Gene Concordance | 33 | 36 |
Collected over Up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Pain - Immediate PGx Testing | 3/527 (0.6%) | 0/527 (0%) | 0/527 (0%) |
| Chronic Pain - Delayed PGx Testing | 3/521 (0.6%) | 0/521 (0%) | 0/521 (0%) |
ITT refers to the Intent To Treat population, while mITT, a subset of ITT, refers to the modified Intent To Treat population. The mITT population is the primary analytical population for the Chronic Pain Trial and includes participants who have a CYP2D6 activity scores \<= 0.75 after accounting for CYP2D6 phenoconversion.
| Age, Continuous(years) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Mean | 58.2 ± 12.2 | 57.8 ± 11.9 | 58.0 ± 12.1 |
| Age, Continuous(years) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Mean | 58.0 ± 10.9 | 57.8 ± 11.3 | 57.9 ± 11.1 |
| Sex: Female, Male(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Female | 373 | 375 | 748 |
| Male | 151 | 146 | 297 |
| Sex: Female, Male(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Female | 95 | 115 | 210 |
| Male | 39 | 31 | 70 |
| Ethnicity (NIH/OMB)(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Hispanic or Latino | 48 | 45 | 93 |
| Not Hispanic or Latino | 468 | 469 | 937 |
| Unknown or Not Reported | 11 | 7 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 12 | 25 |
| Not Hispanic or Latino | 119 | 131 | 250 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Race (NIH/OMB)(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 7 | 13 |
| Asian | 2 | 7 | 9 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 207 | 201 | 408 |
| White | 245 | 245 | 490 |
| More than one race | 13 | 17 | 30 |
| Unknown or Not Reported | 53 | 44 | 97 |
| Race (NIH/OMB)(Participants) | Chronic Pain - Immediate PGx Testing | Chronic Pain - Delayed PGx Testing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 2 | 5 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 49 | 48 | 97 |
| White | 66 | 75 | 141 |
| More than one race | 2 | 6 | 8 |
| Unknown or Not Reported | 15 | 11 | 26 |
1 further baseline measures are reported on the registry.
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