The main purpose of this study is to evaluate how adult cigarette smokers use Enorama NIC-S® nicotine pouches in a real-world setting over the course of 6 weeks.
If you choose to take part in this study, you will first complete screening activities to see if you qualify. If you are eligible, you will try eight Enorama NIC-S® nicotine pouch products over a four-day period and answer questions about your experience using them.
The maximum compensation you may receive is $1,000.
The main purpose of this study is to evaluate how adult cigarette smokers use Enorama NIC-S® nicotine pouches in a real-world setting.
Enorama NIC-S nicotine pouches are tobacco-free oral nicotine products that contain synthetic nicotine. This study will evaluate four flavors (Flavor-Free, Mint, Berry, and Orange) in two nicotine strengths (6 mg and 9 mg).
If you are eligible to continue in the study, you will receive study products to use for about six weeks. During that time, you will complete daily surveys about your cigarette smoking, nicotine pouch use, and any other tobacco or nicotine products you use. You will also complete additional surveys every two weeks about your experiences with the study products.
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, Enorama Pharma AB, 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.
You will be compensated up to $1,000 for your time and inconvenience related to your participation in this study via PayPal. You will need to create a PayPal account to receive payment for participation in this study.
If you complete all study activities, you will receive up to $1,000 in total compensation.
The study is being funded by Enorama Pharma AB.
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:
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.
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