ICON Early Phase Services is conducting a research study for healthy adults ages 21-60. This study is being done to test two moist snuff products.
Vital signs, physical examinations and pregnancy, drug, alcohol and cotinine screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 6 consecutive overnights
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening. For more information, see below.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy adult, meaning no significant medical conditions
- I am between 21 to 60 years of age (inclusive) years old
- My primary tobacco product is natural moist snuff in a tin (fine cut and long cut are acceptable)
- I agree to use the test product exclusively and not use any other tobacco or nicotine-containing product while on study
- I have not used any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy, within 30 days of signing consent
- I have not made an attempt to stop using tobacco or nicotine-containing products within (≤) 30 days prior to signing consent and I am not postponing a decision to quit to participate in this study
- I have not participated in another clinical trial within (≤) 30 days of signing consent
- If Female, I do not have a positive pregnancy test, I am not pregnant or breastfeeding, and I do not intend to become pregnant during the course of the study
- If Female and capable of becoming pregnant, I agree to use an acceptable form of contraception from the time of signing consent until study discharge
- If Female and over 35 years of age, I am not currently using systemic, estrogen-containing contraception or hormone replacement therapy
- I am able to communicate effectively in English with the study personnel
- I do not have a history or presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the time of signing consent
- I do not have a history, presence of, or clinical laboratory test results indicating diabetes
- I do not have any history of cancer except for primary cancers of skin, such as localized basal cell/squamous cell carcinoma
- I do not have a history or presence of bleeding or clotting disorders
- I have not used anticoagulants or aspirin
- I have not donated whole blood within 8 weeks, or donated plasma within 7 days, of signing consent
- I do not drink more than 21 servings of alcoholic beverages per week
- I am not employed by a tobacco or other nicotine product manufacturing company, or the study site.
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. We will be testing for tobacco use and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, or passport. Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records. You will be required to show this same photo ID at all study visits.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.