Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care

00002751

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 eligibility criteria will be randomized into either a PGx-guided care (intervention) arm or standard care (control) arm. The investigators will test the hypothesis that patients with intermediate or poor CYP2D6 metabolism assigned to PGx-guided care arm will experience improved pain control at 3 months compared to patients in the standard care arm. Additionally, the study investigators will be evaluating non-pain related uses of PGx information in the chronic pain population.

2020-12-02

2023-07-11

2024-04-11

Active (not recruiting)

315

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open-label, prospective, randomized trial design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 315, 'type': 'ESTIMATED'}}

2024-03-26