The purpose of this study is to see if nicotine pouches or e-cigarettes could help people stop smoking if they fail to quit using medically approved nicotine replacement therapy (nicotine gum, nicotine lozenges or nicotine patches).
Your participation in this study will last about 10 weeks and will include a two-part screening, three remote visits, and one visit to the study center.
You will be compensated 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 do not complete the study, for any reason, you will be paid for the portions of the study you do complete according to the following schedule:
Payment received as compensation for participation in research is considered taxable income. You are responsible for paying any state, federal or Social Security taxes on the money you receive. If your total payment exceeds $600 in any one calendar year, we are required to report this information to the Internal Revenue Service (IRS). You will be required to provide your Social Security number or tax identification number for payment.
If participants are asked by study staff to return to the center to complete or redo parts of a visit due to equipment malfunctions or other circumstances that are beyond their control, they may be reimbursed for mileage.
Participants who decide to withdraw from the study will be paid for the part of the study they have completed.
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, Foundation for a Smoke-Free World, the U.S. Food and Drug Administration (FDA), other health authorities, and the Institutional Review Board (IRB) may inspect your hard-copy and electronically stored study 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.
This study was funded with a grant from the Foundation for a Smoke-Free World, Inc. (“FSFW”), a US nonprofit 501(c)(3) private foundation. The contents, selection, and presentation of facts, as well as any opinions expressed herein are the sole responsibility of the authors and under no circumstances shall be regarded as reflecting the positions of the Foundation for a Smoke-Free World, Inc. FSFW’s mission is to end smoking in this generation.
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 Informed Consent Form (ICF) that outlines important information to consider before joining the study. The study staff will review 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 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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