Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care (PGx-ACT)

MedStar Health

Status: Active, not recruiting

Conditions: Chronic Pain

Treatments: Genetic: Pharmacogenetic Testing; Other: Delayed pharmacogenetic testing; Other: Pharmacist Consultation Note

Study type: Interventional

Funder types: Other

Identifiers

NCT04685304

00002751

Details and patient eligibility

About

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.

Full 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 analagesic can be guided by pharmacogenomic (PGx) data via existing Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. The rationale for PGx-guided treatment is based upon the CYP2D6 bioactivation of tramadol, codeine, and hydrocodone, whereas patients with reduced CYP2D6 function may not activate these drugs and therefore may not experience the effective treatment from these drugs. A prior pragmatic proof-of-concept trial testing the effects of CYP2D6-guided opioid prescribing on pain control provides additional evidence for this study.

This study is designed to evaluate the impact of PGx-guided treatment on chronic pain score improvement compared to standard conventional treatment in a pragmatic setting. It will test for multiple genes to enable incorporation of CPIC guidelines for other drugs (e.g., antidepressants, nonsteroidal antiinflammatory drugs), account for drug-drug interactions, and utilize recently updated CYP2D6 phenotype translation thresholds.

Primary objective: Identify the effects of providing pharmacogenomic (PGx) results and recommendations for patients with chronic pain who are treated in primary care clinics versus standard care.

Secondary objective: Explore non-pain related uses of PGx information in a population with chronic pain.

Enrollment: 315 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

315 participants in 2 patient groups

PGx-guided care

Experimental group

Description:

Pharmacogenetic results (e.g., CYP2D6, CYP2C9) and a pharmacist consultation will be provided to their primary care provider. This consultation note (PharmD consult) will aid primary care providers in the interpretation and application of PGx results in prescribing decisions. The ultimate prescribing decision is at the discretion of the primary care provider and patient.

Treatment:

Genetic: Pharmacogenetic Testing

Other: Pharmacist Consultation Note

Standard care

Active Comparator group

Description:

Care for study subjects will occur without PGx results at the discretion of the study subject, their primary care provider. After the active participation ends (i.e. after the three month follow up is complete), PGx results and a PharmD consult will be provided similar to the PGx-guided arm.

Treatment:

Other: Delayed pharmacogenetic testing