Pharmacogenetic Testing and Chronic Pain

NCT05259865 | Suspended

• 1 other identifier: 2020-043
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Understanding the impact of genetics could aid rational, precision drug choices. In the current study, investigators will focus on whether genetic analysis of drug processing using the Inagene platform could predict efficacy and side effect profile in patients prescribed medication for pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of PGx testing for pain response

  For the main analysis, the phenotypes will be grouped 1\&2 (do not prescribe) and 3\&4 (prescribe) and compared against whether patient responded or not to determine sensitivity and specificity of the genetic testing. Sub-analysis will determine for those that did not respond and whether this was a result of side effects or a lack of efficacy

  up to 8 weeks post initial medication prescription

Secondary Outcomes (1)

• Sensitivity and Specificity of PGx testing for side effects

  up to 8 weeks post initial medication prescription

Study Arms (1)

Patients with chronic pain

Patients seen in clinic agreeing to participate in trial by completing clinical questionnaires and genetic testing

Diagnostic Test: Genetic test for drug response prediction

Interventions

Genetic test for drug response prediction DIAGNOSTIC_TEST

There is interest in whether genetic analysis of how a given drug is processed for a patient can help with rational drug choices (i.e. most efficacious, with least side effects/interactions, in the fastest time). This appears to have some early support in cardiac, psychiatric and acute pain studies. All participants enrolled in the study will provide consent and a buccal cell sample for genotyping and standard patient reported outcomes questionnaires at the beginning of the study.

Patients with chronic pain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be Canadian Forces members between the ages of 18-60 years old, suffering from chronic pain, seen within the Canadian Forces Ottawa Physical Medicine and Rehabilitation clinic (CFO-P).

You may qualify if:

• male and female between 18 and 60 years old
• seen within the CFO-P
• diagnosed by a physician with one or more chronic pain condition.

You may not qualify if:

• adults who are unable to give their own consent
• contraindications to a buccal swab
• uncontrolled mental health issues determined by clinical judgement without mental health treatment and/or presence of active suicidal ideation

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Study Sites (1)

Canadian Forces Health Services Centre

Ottawa, Ontario, K1J6L4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Our study will use Inagene commercial platform, a genomics-guided personalized medication management service that aims to predict how efficacious medications are and limiting potential side effects for a given patient. The platform itself uses genetic information and provides a report listing 4 possible scores for each tested medication, 1) do not use 2) caution 3) use as directed 4) preferred. This is consistent with recently published guidance for allele function status where phenotypes were sub-classified (i.e. ultrarapid, normal, intermediate and poor metabolizer This appears to have some early support in cardiac, psychiatric and acute pain studies. In fact, the US Federal Drug Administration have made dosing recommendations to included CPY2D6 and CYP2C19 polymorphisms for certain psychotropic medications \[ \]

MeSH Terms

Conditions

Chronic Pain

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 2, 2022
• Study Start: September 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)