N/A
Completed N=1,048
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
Source: ClinicalTrials.gov NCT05966142 ↗Enrolled (actual)
1,048
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Change in Pain Intensity — -0.7; -0.8 score on a scale — p=0.5913
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
-0.7; -0.8 | 0.5913 |
| SECONDARY Pain Reduction Magnitude |
-0.1; -0.1 | 0.6803 |
| SECONDARY Number of Participants With Clinically Significant Pain Reduction |
17; 27 | 0.1228 |
| SECONDARY Prescription Pain Medication Misuse as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) |
40.1; 40.5 | 0.5252 |
| SECONDARY Number of Participants With Drug-Gene Concordance |
33; 36 | 0.9657 |
Eligibility Criteria
Inclusion Criteria
Chronic Pain Trial
- Age ≥ 18 years
- English speaking or Spanish speaking
- Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
- History of pain for at least the last 3 months
- Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management
Exclusion Criteria
Trial-wide:
- Life expectancy less than 12 months
- Are too cognitively impaired to provide informed consent and/or complete study protocol
- Are institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated)
- Have a history of allogeneic stem cell transplant or liver transplant
- People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial
Chronic Pain
- Plan to move out of the area within 6 months of enrollment
- Undergoing treatment for an active cancer diagnosis
- Currently taking daily opioids other than tramadol, codeine or hydrocodone
Data sourced from ClinicalTrials.gov (NCT05966142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.