Status:
COMPLETED
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
University of Florida
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
1048 Patients enrolled
Trial Details
Trial ID
NCT05966142
Start Date
February 24 2021
End Date
May 10 2024
Last Update
May 28 2025
Active Locations (10)
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1
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
2
University of Florida - Jacksonville
Jacksonville, Florida, United States, 32209
3
Eskenazi Health
Indianapolis, Indiana, United States, 46202
4
Indiana University
Indianapolis, Indiana, United States, 46202