Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care

NCT ID: NCT04685304

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2024-04-11

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 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.

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 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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PGx-guided care

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.

Group Type: EXPERIMENTAL

Pharmacogenetic Testing

Intervention Type: GENETIC

Genetic results will be reported for CYP2D6, CYP2C19, CYP2C9, CYP2B6, CYP3A4, CYP3A5, SLCO1B1, TPMT, and VKORC1.

Pharmacist Consultation Note

Intervention Type: OTHER

Recommendations will be based on phenotypes translated from genetic data in accordance with CPIC guidelines. Drug interactions will be incorporated into phenotype assignments when appropriate.

Standard care

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.

Group Type: ACTIVE_COMPARATOR

Delayed pharmacogenetic testing

Intervention Type: OTHER

Pharmacogenetic testing and a pharmacist consultation note will be provided to participants provided to the standard care arm once 3 months have passed since their baseline visit.

Interventions

Pharmacogenetic Testing

Genetic results will be reported for CYP2D6, CYP2C19, CYP2C9, CYP2B6, CYP3A4, CYP3A5, SLCO1B1, TPMT, and VKORC1.

Intervention Type: GENETIC

Pharmacist Consultation Note

Recommendations will be based on phenotypes translated from genetic data in accordance with CPIC guidelines. Drug interactions will be incorporated into phenotype assignments when appropriate.

Intervention Type: OTHER

Delayed pharmacogenetic testing

Pharmacogenetic testing and a pharmacist consultation note will be provided to participants provided to the standard care arm once 3 months have passed since their baseline visit.

Intervention Type: OTHER

Other Intervention Names

pharmacogenomics; CYP2D6; CYP2C9; PGx

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kailos Genetics, Inc.

UNKNOWN

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Max Smith, PharmD

Role: PRINCIPAL_INVESTIGATOR

MedStar Health

Locations

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

00002751

Identifier Type: -

Identifier Source: org_study_id