This study will help establish the safety or risks of combining botanicals with pharmaceutical drugs.
The purpose of this research study is to determine if the botanical product oregano changes how certain drugs are broken down by the body. This study will consist of 4 study arms. During Arm 1, you will be given a single dose of an oregano supplement. During Arm 2, you will be given a single dose of a drug cocktail consisting of caffeine, dextromethorphan, losartan, midazolam syrup, and omeprazole. During Arm 3, you will be given both oregano and the cocktail. During Arm 4, you will take oregano daily at home for 5 days. You will then return to the clinical study site, where you will be given oregano and the cocktail. Blood will be drawn from an intravenous line during all Arms. Urine samples will also be collected during all arms. The inpatient days for each arm will be followed by an outpatient visit the following morning, when blood will be drawn, and you will return your urine jug(s). You will receive a screening medical exam and will undergo routine blood and urine laboratory tests, as well as a urine toxicology screen for common drugs of abuse prior to participating in the study.
You will receive up to $1,150 for completing the study
You may be eligible to take part in this study if you
- Are 18-64 years old and healthy;
- Are not taking any medications, dietary/herbal supplements, or fruit juices that can interfere with your ability to eliminate the study drugs;
- Are willing to abstain from cannabis/marijuana, hemp, THC, and CBD products for several weeks;
- Are willing to abstain from consuming caffeine-containing products and beverages the evening before and the morning of each study day;
- Are willing to abstain from consuming any alcoholic beverages for at least 1 day prior to any study day and during the study day;
- Are willing to use an additional method of non-hormonal birth control (such as abstinence, copper IUD, condom) for the duration of the study and for 3 weeks after. This would not require any changes to current use or non-use of hormonal birth control;
- Are willing to abstain from taking oregano supplements for at least two weeks prior to and for the duration of the study; and
- Have the time to participate.
You will not be eligible to take part in this study if you
- Have a chronic illness or major psychiatric illness;
- Are pregnant or breastfeeding;
- Have a history of intolerance or allergy to oregano or any of the cocktail drugs;
- Currently use or have recently used drugs or other illicit substances for recreational purposes;
- Have used cannabis/marijuana, hemp, CBD-and/or THC-containing products within the past month;
- Are taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products) known to alter the pharmacokinetics of either oregano or the cocktail drugs; and/or
- Are unable to speak, read, and understand English.
The Washington State University College of Pharmacy and Pharmaceutical Sciences is conducting this research study through funding provided by the National Institutes of Health.
For more information about this study, please contact: deena.hadi@wsu.edu
