Evaluating adverse drug reactions in patients taking multiple medications
The Texas Interprofessional Pharmacogenomics (IPGx) PILOT Cohort
Texas A&M University · NCT06219720
This study is testing how taking multiple medications affects side effects in at-risk patients to help doctors make better treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Texas A&M University (other) |
| Locations | 1 site (Bryan, Texas) |
| Trial ID | NCT06219720 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of polypharmacy on adverse drug reactions (ADRs) in at-risk patients using advanced pharmacogenomic technology. The study will analyze data from a pilot cohort to optimize pharmacotherapy regimens and develop a clinical decision support dashboard to identify necessary modifications in drug regimens. Additionally, it will evaluate the capacity of CYP P450 enzymatic pathways in patients on multiple medications and assess the feasibility of integrating informatics workflows between the laboratory and clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 and over who are taking five or more medications, including over-the-counter drugs and supplements.
Not a fit: Patients with a history of certain cancers, active liver disease, or those who are in hospice care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective medication management for patients on multiple drugs, reducing the risk of adverse drug reactions.
How similar studies have performed: While there have been various medication management programs, this study's specific focus on pharmacogenomics in polypharmacy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * People 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, undergo a comprehensive history and physical examination. * All genders. * Age 45 and over Exclusion Criteria: * 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 * Pregnant patients will be excluded * Unable/unwilling to consent. * Unable to verbally communicate and comprehend English/Spanish language.
Where this trial is running
Bryan, Texas
- The Interprofessional Pharmacogenomics (IPGx) Clinic — Bryan, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Kenneth S Ramos, MD — Texas A&M IBT
- Study coordinator: Kenneth S Ramos, MD
- Email: kramos@tamu.edu
- Phone: 7136777740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adverse Drug Reaction