Status:
ACTIVE_NOT_RECRUITING
Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Kailos Genetics, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pharmacogenomics (PGx) Applied to Chronic pain Treatment in primary care (PGx-ACT) is an open-label, prospective, randomized trial. Participants prescribed a relevant opioid and meet additional eligib...
Detailed Description
Chronic pain affects millions of Americans on an annual basis. Pharmacologic pain management strategies, which includes opioid analgesics, are widely used to treat chronic pain. The selection of an an...
Eligibility Criteria
Inclusion
- Any sex, 18 years of age or older
- Report chronic pain (i.e., pain for at least 3 months),
- Have a current prescription (prior to the enrollment visit) for either hydrocodone, tramadol, or codeine.
- This opioid is ordered by a provider associated with MedStar Health
- Treated at a participating primary care clinic (section 6)
- Willing and able to comply with scheduled visits, buccal sample collection, and other trial-related procedures.
Exclusion
- Patients who have received a liver or bone marrow transplant.
- Patients with documented opioid use disorder (e.g., opioid use disorder on the problem list) or have current prescriptions for buprenorphine represent a level of complexity that are beyond the scope of this trial.
- Any surgical procedure that typically necessitates post-operative opioid (e.g., laparoscopic cholecystectomy, unilateral open and laparoscopic inguinal hernia repair, partial mastectomy with and without sentinel lymph node biopsy, uncomplicated cesarean delivery, minimally invasive hysterectomy, robotic retropubic prostatectomy, arthroscopic partial meniscectomy, and thyroidectomy) within the past 3 months or in the study period.
- Surgeries or procedures that would not typically require postoperative opioids are permissible (e.g., (uncomplicated vaginal delivery, cochlear implant, and cardiac catheterization).
- A urine drug screen at enrollment or during the study identifies the patient ingesting a narcotic medication that is not prescribed to them. It is not a study requirement that any patients have completed a urine drug screen as this will be considered part of clinical practice per the treating provider.
- Known to have previously received CYP2D6 testing.
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 11 2024
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04685304
Start Date
December 2 2020
End Date
April 11 2024
Last Update
March 26 2024
Active Locations (1)
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1
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States, 21239