Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care

NCT04685304 | Active Not Recruiting

• 1 other identifier: 00002751
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

pharmacogenetics; pharmacogenomics; CYP2D6; CYP2C9; tramadol; codeine; hydrocodone; NSAIDs; opioids

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  The change in composite pain intensity among CYP2D6 poor or intermediate metabolizers between the baseline visit and 3 months. The composite pain intensity is defined as the mean of current, worst, and average pain intensity. The PROMIS Scale v1.0 Pain Intensity 3a will be used to collected pain intensity data. The scale asks three separate questions regarding how intense the patient's pain is on average over the past 7 days, at it's worst over the past 7 days, and at that moment. Options range from 1 (had no pain) to 5 (very severe).

  3 months

Secondary Outcomes (6)

• Opioid Use

  3 months

• Recommendation Acceptance

  first encounter (baseline visit), 3 months, 12 months

• Significant Change in Pain Intensity

  3 months

• Change in Physical Function

  3 months

• Change in Pain Interference Symptoms

  3 months

Study Arms (2)

PGx-guided care

EXPERIMENTAL

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.

Genetic: Pharmacogenetic Testing; Other: Pharmacist Consultation Note

Standard care

ACTIVE COMPARATOR

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.

Other: Delayed pharmacogenetic testing

Interventions

Pharmacogenetic Testing GENETIC

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

Also known as: pharmacogenomics, CYP2D6, CYP2C9, PGx

PGx-guided care

Pharmacist Consultation Note 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.

PGx-guided care

Delayed pharmacogenetic testing 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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Kailos Genetics, Inc.: collaborator

Study Sites (1)

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Pharmacogenomic Testing; Cytochrome P-450 CYP2D6; Cytochrome P-450 CYP2C9

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Aryl Hydrocarbon Hydroxylases; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Cytochrome P450 Family 2; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins; Limonene Hydroxylases

Study Officials

• Max Smith, PharmD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label, prospective, randomized trial design

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 28, 2020
• Study Start: December 2, 2020
• Primary Completion: July 11, 2023
• Study Completion: April 11, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

US (1)