Clinical trial NCT04685304: Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
Official title: Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: pharmacogenetics
pharmacogenomics
CYP2D6
CYP2C9
tramadol
codeine
hydrocodone
NSAIDs
opioids
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Kailos Genetics, Inc.
First posted: 2020-12-28
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, prospective, randomized trial design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: 3 months
Secondary outcomes:
measure: Opioid Use
timeFrame: 3 months
measure: Recommendation Acceptance
timeFrame: first encounter (baseline visit), 3 months, 12 months
measure: Significant Change in Pain Intensity
timeFrame: 3 months
measure: Change in Physical Function
timeFrame: 3 months
measure: Change in Pain Interference Symptoms
timeFrame: 3 months
measure: Change in Pain Intensity Among Those with Therapy Concordant with PGx Recommendations
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
Study officials:
affiliation: MedStar Health
name: Max Smith, PharmD
role: PRINCIPAL_INVESTIGATOR
References: