This study will help establish the safety or risks of combining botanicals with pharmaceutical drugs.
The purpose of this research study is to determine how the body processes a constituent found in the herbal product cinnamon, trans-cinnamaldehyde (CA), and to evaluate whether it can alter the enzyme that is responsible for breaking down nicotine in the body. You will receive a screening medical exam and will undergo routine blood and urine laboratory tests, as well a urine toxicology screen for common drugs of abuse, prior to participating in the study.
The study will consist of two study parts:
- Part 1: In our clinic you will receive a single dose of nicotine gum and then blood samples will be collected through an intravenous (IV) line.
- Part 2: At home you will self-administer CA orally for 3 days. On the 4th day, in our clinic, you will receive a single dose of CA and nicotine gum, with blood samples collected through an intravenous (IV) line.
You will receive up to $370 for completing the study
You may be eligible to take part in this study if you
- Age 18-64 years old and healthy
- Not taking any medications, dietary/herbal supplements, or citrus juices that can interfere with your ability to eliminate study drugs
- Willing to abstain from consuming caffeinated and alcohol products the evening before and the morning of the first day of each study part
- If female, willing to use acceptable method of contraception that doesn’t include oral contraceptive pills for the duration of the study and to continue for 3 weeks after the conclusion of participation
- No known allergies to over-the-counter nicotine gum, cinnamon products, and/or gelatin
- Have the time to participate
You will not be eligible to take part in this study if you
- Have a chronic illness.
- Have a hematologic (blood) disorder Have a history of drug or alcohol abuse Have any major psychiatric illnesses.
- Currently a smoker or use nicotine products (gum, patches, vapes).
- Female and currently pregnant or breastfeeding.
- Have a history of allergies/intolerance to nicotine gum, cinnamon products, and/or gelatin.
- Currently taking prescriptions and/or non-prescription medications (including dietary/herbal supplements) known to alter the effects of any of the study drugs.
| STUDY VISITS | PAYMENTS |
| Screening visit – outpatient | $25 gift card |
| Part 1 inpatient day | $150 |
| Part 2 self-administration period (3 days) | $45 |
| Part 2 inpatient day | $150 |
| Total | $370 |
The WSU Institutional Review Board has reviewed and approved this research project for human subject participation.
For more information about this study, please contact: deena.hadi@wsu.edu
