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

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenetic Testing
Pharmacist Consultation Note
Delayed pharmacogenetic testing
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring pharmacogenetics, pharmacogenomics, CYP2D6, CYP2C9, tramadol, codeine, hydrocodone, NSAIDs, opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MedStar Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PGx-guided care

Standard care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Opioid Use
The change number of morphine milliequivalents (MMEs) prescribed between baseline and 3 months.
Recommendation Acceptance
Proportion of patients with prescribing decisions concordant with PGx with recommendations
Significant Change in Pain Intensity
The proportion of patients with at least a 30% improvement in composite pain intensity.
Change in Physical Function
Using the PROMIS-29 Profile v2.0, assess the change in physical function between baseline and 3 months. The scale includes options that range from 1 (without any difficulty) to 5 (unable to do).
Change in Pain Interference Symptoms
Using the PROMIS-29 Profile v2.0, assess the change in symptoms between baseline and 3 months. The scale includes options that range from 1 (not at all) to 5 (very much).
Change in Pain Intensity Among Those with Therapy Concordant with PGx Recommendations
The subset of patients with actionable results (e.g., CYP2D6 poor or intermediate metabolism) will have pain intensity compared between those with therapy concordant and discordant with recommendations. The change in composite pain intensity 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).

Full Information

First Posted
December 4, 2020
Last Updated
March 13, 2023
Sponsor
Medstar Health Research Institute
Collaborators
Kailos Genetics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04685304
Brief Title
Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
Acronym
PGx-ACT
Official Title
Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Kailos Genetics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
pharmacogenetics, pharmacogenomics, CYP2D6, CYP2C9, tramadol, codeine, hydrocodone, NSAIDs, opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An open-label, prospective, randomized trial design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PGx-guided care
Arm Type
Experimental
Arm 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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Genetic
Intervention Name(s)
Pharmacogenetic Testing
Other Intervention Name(s)
pharmacogenomics, CYP2D6, CYP2C9, PGx
Intervention Description
Genetic results will be reported for CYP2D6, CYP2C19, CYP2C9, CYP2B6, CYP3A4, CYP3A5, SLCO1B1, TPMT, and VKORC1.
Intervention Type
Other
Intervention Name(s)
Pharmacist Consultation Note
Intervention Description
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
Intervention Name(s)
Delayed pharmacogenetic testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Intensity
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Opioid Use
Description
The change number of morphine milliequivalents (MMEs) prescribed between baseline and 3 months.
Time Frame
3 months
Title
Recommendation Acceptance
Description
Proportion of patients with prescribing decisions concordant with PGx with recommendations
Time Frame
first encounter (baseline visit), 3 months, 12 months
Title
Significant Change in Pain Intensity
Description
The proportion of patients with at least a 30% improvement in composite pain intensity.
Time Frame
3 months
Title
Change in Physical Function
Description
Using the PROMIS-29 Profile v2.0, assess the change in physical function between baseline and 3 months. The scale includes options that range from 1 (without any difficulty) to 5 (unable to do).
Time Frame
3 months
Title
Change in Pain Interference Symptoms
Description
Using the PROMIS-29 Profile v2.0, assess the change in symptoms between baseline and 3 months. The scale includes options that range from 1 (not at all) to 5 (very much).
Time Frame
3 months
Title
Change in Pain Intensity Among Those with Therapy Concordant with PGx Recommendations
Description
The subset of patients with actionable results (e.g., CYP2D6 poor or intermediate metabolism) will have pain intensity compared between those with therapy concordant and discordant with recommendations. The change in composite pain intensity 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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Smith, PharmD
Organizational Affiliation
MedStar Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Good Samaritan Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States

12. IPD Sharing Statement

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Pharmacogenomics Applied to Chronic Pain Treatment in Primary Care

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