Observational Study on Polypharmacy and Adverse Drug Reactions

This observational study aims to understand why some people experience adverse drug reactions (ADRs) when taking many medications (polypharmacy). Researchers will use whole genome sequencing (looking at all your genes) to see how your unique genetic makeup might affect how your body handles different drugs. The goal is to find better ways to choose medications for patients taking five or more drugs, including over-the-counter medicines, supplements, or recreational drugs. Success will be measured by connecting your genetic information with any ADRs you experience over 180 days. This study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to enroll 50 participants.
What's involved
You would need to give urine, blood, and buccal (cheek) swab samples for genetic data, and have a full health examination. You must also be able to understand and give consent.
Compensation
Not stated in the trial record.
Follow-up
Your pharmacogenomic genotype (genetic information related to drug response) will be linked with any adverse drug reactions you experience for 180 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06766071

IPGx PILOT Whole Genome Sequencing Extension Cohort

Recruiting
Not specifiedAges 18+Observational
Texas A&M University
~50 participants
Updated 2025-01-09 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacogenomic genotype with corresponding ADR phenotype
Measured over 180 days
Adverse Drug Reaction (ADR)
Polypharmacy Patients
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

Individuals taking 5 or more medications, including over the counter drugs, supplements, natural products, cannabis produces, or other recreational drugs.
Ability to give and comprehend the consent process.
Consent to donate urine samples, genetic data through buccal swabs and blood samples, and undergo a comprehensive history and physical examination.
All genders
Age 18-100

Exclusion

Subject has been diagnosed or is being treated for any cancer other than basal cell cancer in the last 5 years. Patients with metastatic melanoma in the last 5 years will be excluded.
Admitted to hospice.
Patient has ever been diagnosed with Hepatitis B or C.
Patient has ever been diagnosed with active liver disease, hepatomegaly, grossly abnormal liver function. Meld score \>10, ALT, or AST \>100U/L or an AST/ALT ratio \>2
Patients taking imidazole antifungal medication.
Declines to participate or interact with staff/share their medical status.
A diagnosis of Alzheimer's disease or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.
Pregnant patients will be excluded.
Individuals who are unable or unwilling to provide consent will be excluded.
Unable to verbally communicate and comprehend English language.
  • Pharmacogenomic genotype with corresponding ADR phenotype180 days

    Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians to evaluate genotyping and ADR. Clinical staff will obtain a buccal swab to collect DNA for a pharmacogenomic evaluation pursuant to the sample collection kits from the CLIA lab, which will occur at the start of the study period. Blood chemistry will be taken from the EMR.