A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
CompletedNot applicableNCT05966142
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Depression and Opioid Pragmatic Trial in Pharmacogenetics
- Conditions
- Interventions
- Other: Pharmacogenetic testing
- Other: Clinical decisions support
- Sponsor
- Duke University
- Collaborators
- National Human Genome Research Institute (NHGRI); University of Florida; Vanderbilt University Medical Center; Indiana University; Icahn School of Medicine at Mount Sinai
- Start date
- 2021-02-24
- Primary completion
- 2024-05-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 10
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05966142