Clinical Research Directory

Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product

Kratom is a botanical natural product that has opioid-like effects. Kratom is commonly used to self-treat withdrawal symptoms associated with opioid addiction, as well as pain. Kratom products include pills, extracts, and powders, most of which contain two primary psychoactive constituents: mitragynine and 7-hydroxymitragynine. Preliminary data from the investigator's laboratory has shown that these two constituents and extracts made from commercially available kratom products are strong inhibitors of the drug metabolizing enzymes cytochrome P450 (CYP) 2D6 and CYP3A4. These enzymes are responsible for metabolizing more than 50% of marketed drugs, including several opioids, benzodiazepines, and antidepressants. Thus, co-consumption of kratom products with drugs metabolized by CYP2D6 and CYP3A4 could increase the risk of serious adverse effects. The effects of a well-characterized kratom product on CYP2D6 and CYP3A4 activity will be assessed in healthy volunteers using a 'cocktail' approach consisting of the validated probe drugs dextromethorphan and midazolam. Results will (1) provide useful information regarding risks associated with co-consuming kratom with opioids and other CYP2D6 and CYP3A4 drug substrates and (2) inform the design of future kratom-drug interactions studies.

Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon

The purpose of this study is to evaluate a well-characterized, commercially available cinnamon dietary supplement as a precipitant of pharmacokinetic interactions with cytochrome P450 (CYP) 2A6 drug substrates in healthy volunteers. Nicotine gum will be used as the CYP2A6 probe drug (i.e., positive control) and letrozole as a high-impact object drug. Results will be used to inform future research on the potential use of cinnamon as a smoking cessation agent, as well as the clinical impact on pharmacotherapeutic regimens involving letrozole in cancer patients.

Dietary Supplements Among Cancer Patients: Tolerance, Impact on Medications, and Potential Drug Interactions

The goal of this observational study is to To assess the prevalence and patterns of dietary supplement use among patients with cancer and to analyze the impact of these supplements in the context of anticancer medical treatments, including chemotherapy, targeted therapies, hormone therapy, and immunotherapies. The main questions it aims to answer : * What is the prevalence of dietary supplement use among cancer patients, and what is their tolerance profile? * Are there any potential drug interactions between dietary supplements and anticancer medications? Participants will: * Provide sociodemographic information, including age, sex, educational level, and other relevant characteristics. * Report their use of dietary supplements, including the types of supplements consumed (e.g., vitamins, minerals, herbal products), dietary practices, frequency and duration of use, and reasons for consumption (e.g., medical recommendation or self-medication). * Report any perceived adverse effects related to dietary supplement use to assess tolerance. * Allow the collection of relevant clinical data from their medical records, including cancer type, ongoing anticancer treatments, and treatment-related adverse effects.