Are you interested in exploring cigarette alternatives?

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: 

• You will receive $25 for completing the questionnaires during the first part of the screening. You will receive $20 for using the screening kit and completing the additional questionnaires during the second part of the screening. If you are eligible after all other screening procedures, you will be asked to provide a urine sample. Once we receive your urine sample you will receive an additional payment of $50. You will receive compensation for samples that you send ONLY if you meet the criteria for taking part in this study.

• After all screening procedures are completed, and if you are eligible to continue in the study, then you will receive $5 a day for responding to daily messages asking about the number of cigarettes you are smoking and $5 for each CO sample you provide (for up to seven days – max $70).
• You will receive $50 for completing each remote visit ($150 total).
• You will receive $125 for coming to the study center during week 5 to provide a urine sample and to pick up study products. 
• At the end of week 10, once we receive your urine sample you will receive an additional payment of $50.
• You will receive $5 for responding to weekly questionnaires (max $50).
• You will receive $5 for each CO sample you provide (max $120).
• You will receive $5 a day for responding to daily surveys through eResearch. In order to receive compensation, you will need to answer all of the questions before you receive your next survey. Daily surveys will be sent once per day for approximately 70 days (max $350).
• You will receive $50 for responding to six-month follow-up questionnaires.
• You will receive $25 for providing a CO sample at six-month follow-up.

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: 

• 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 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.