Recruiting

Observational Study

Sponsor:

Texas A&M University

Code:

NCT06219720

Conditions

Adverse Drug Reaction

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The investigator's primary aim is to evaluate polypharmacy-associated adverse drug reactions (ADR) in a pilot study of at-risk patients using state-of-the-art pharmacogenomic technology and to use this information to make recommendations for optimization of pharmacotherapy regimens. The data from the pilot cohort will be used to optimize and integrate a customized electronic decision support (clinical semantic network; CSN) dashboard to identify drug regimens that should be modified, replaced, or discontinued. A secondary objective of the pilot study is to evaluate the capacity/saturation of CYP P450 enzymatic pathways in polypharmacy patients. A third objective is to determine the feasibility of the planned informatics workflows between the CLIA lab, the EMR, and the Family Medicine Practice.

Conditions

Adverse Drug Reaction

Study ID

NCT06219720

Start date

Dec 15, 2021

Status verified date

Aug, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Frequency and nature of ADRs on the Naranjo Scale [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

Kenneth S Ramos, MD

7136777740kramos@tamu.edu

Locations

The Interprofessional Pharmacogenomics (IPGx) Clinic

Recruiting

Bryan, Texas, United States, 77802

Contacts

Gabriel Neal, MD

979-436-0399gneal@tamu.edu

DeLona Bacote, MS

713-677-7735dabacote@tamu.edu

Principal Investigator:

Kenneth S Ramos, MD,PhD

More Information

Sponsor

Texas A&M University

Last update posted

Sep 12, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-09-12.