Do you want to participate in a paid research study about nicotine pouches?

The purpose of this study is to examine levels of nicotine in your blood after controlled use of Enorama nicotine pouches (NIC-S®), another marketed brand of nicotine pouches, and your usual brand cigarettes.

Your first visit will be a screening visit to determine if it is safe for you to participate.

You will come to the study center for 5 additional visits. At each visit the following will occur:

• You will use a nicotine pouch (for 60 minutes) or smoke one of your cigarettes.
• Blood samples will be taken using an intravenous small plastic catheter or tube (IV) that will be put in your arm. The IV line will make it easier to collect the necessary number of blood samples. The blood samples will be used to determine nicotine levels in your blood.
• You will complete questionnaires about your cravings for a cigarette and your experience with the nicotine pouches.

• Between the ages of 22-65
• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English
• Not pregnant, nursing, or planning to become pregnant
• Smokes 10 or more combustible cigarettes per day
• Has been smoking combustible cigarettes for a year or more
• Interested in trying a nicotine pouch product
• No current serious medical conditions

Your participation in this study will last approximately 4-8 weeks. You will come to the research center for a screening visit that is 2-3 hours and 5 study visits that are 4 hours each. You can attend a maximum of two product use visits in one week. 

You will be paid up to a total of approximately $3,000 if you complete this study. If you do not complete the study, for any reason, you will be paid for the parts of the study you do complete according to the following schedule.

• Screening Visit ($50)
• Controlled Product Use 1 ($450)
• Controlled Product Use 2 ($500)
• Controlled Product Use 3 ($550)
• Controlled Product Use 4 ($600)
• Controlled Product Use 5 ($650)

If you agree to take part in this research study, information about your identity, health and your participation will be collected, recorded, and stored by study staff.

Rose Research Center, the FDA, the Sponsor, other health authorities, and the Institutional Review Board (IRB) may inspect your hard-copy and electronically stored research records which may include your name, address and other personal information that identifies you. If necessary, some of these records may be copied during these inspections. 

The results of this research study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.

The informed consent process provides you with the information required to ensure you make an informed decision about participation in the clinical research study. This process will: 

• Help you to understand the study
• Give you an opportunity to ask questions and to consider whether to participate 
• Obtain your voluntary agreement to participate
• Continue to provide information as the clinical research study progresses 

Before participating, we will take you through a written Informed Consent Form (ICF) that outlines important information to consider before joining the study. The study staff will go through this document with you and answer any questions you may have. This document provides details of the study, such as study expectations, duration, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF. After you have read and discussed all the information about the study, you can decide whether or not to digitally sign the consent form. This consent form is not a contract, and you are always free to leave the study at any time and for any reason, with no penalty to you. Additionally, during your participation, the study staff will let you know in a timely manner of any information that may change your mind about participating.