Clinical trial: NCT05236894
Section: Confidentiality
Subsections: 125 **Confidentiality:**

126 127 We will work to make sure that no one sees your online responses without approval. But, 128 because we are using the Internet, there is a chance that someone could access your online 129 responses without permission. In some cases, this information could be used to identify you.  
130 131 Confidentiality will be maintained by numerically coding all data, disguising identifying 132 information, and keeping data locked in file drawers or in a secure, password protected 133 database. All biospecimen samples are kept in a locked freezer and also will be deidentified. 134 Names of participants will be kept separate from participant data. Only study staff will have 135 the information that connects participants' names and ID numbers. All electronic data will be 136 numerically coded and stored in a password-protected database, on a password-protected 137 computer in a secure research space. Participant information will be accessible only to 138 research staff, who are pledged to confidentiality and have completed training in the ethical 139 conduct of research. Identifying information will not be reported in any publications.  
140 141 Also, there may be circumstances where this information must be released. For example, 142 personal information regarding your participation in this study may be disclosed if required by 143 state law. Also, your records may be reviewed by the following groups (as applicable to the 144 research): 145 x Office for Human Research Protections or other federal, state, or international 146 regulatory agencies; 147 x The Ohio State University Institutional Review Board or Office of Responsible 148 Research Practices; 149 x Authorized Ohio State University staff not involved in the study may be aware that 150 you are participating in a research study and have access to your information; and 151 x The sponsor, if any, or agency (including the Food and Drug Administration for FDA152 regulated research) supporting the study.  
153 154 Your de-identified information may be used or shared with other researchers without your 155 additional informed consent. Your deidentified blood samples may be sent to an outside lab 156 for analysis. Your name would never be connected with the sample.  
157 158 We will not recontact you every time we use your sample or data from the questionnaires for 159 analysis.  
160 161 **Future Research:**
162 163 You will be given the option to be contacted for future, related studies.  
164 165 Your selection for being contacted about related studies will not impact your eligibility for 166 this study.  
167 168 169 **Incentives:**
170 By law, payments to participants are considered taxable income. You may receive up to $350 171 for your participation. After each visit, you will receive $100 on a pre-paid ClinCard. If you 172 complete all of your visits in a month, you will receive a $50 bonus at the end of your third 173 visit. If it is not possible for you to perform study procedures during your visit, we will 174 provide $50 on a pre-paid ClinCard to thank you for your time.  
175 176 177
Clinical trial: NCT05236894
Section: Participant's Rights
Subsections: 178 **Participant Rights:**

179 You may refuse to participate in this study without penalty or loss of benefits to which you 180 are otherwise entitled. If you are a student or employee at Ohio State, your decision will not 181 affect your grades or employment status.  
182 183 Additionally, if at any point you decide to quit tobacco and/or nicotine products, please let us 184 know and we will withdraw you from our study. If you wish to withdraw from the study, 185 please contact the program manager Hayley Curran by phone or email and state your desire to 186 withdraw from the study. Our phone number is 614-366-9693 and our lab email is BKH187 Lab@osumc.edu If you withdraw, data you previously provided to the study may have 188 already been used for analyses or publication; however, no new information will be accessed 189 or analyzed from the time of withdrawal onward.  
190 191 If you choose to participate in the study, you may discontinue participation at any time 192 without penalty or loss of benefits. By agreeing to participate, you do not give up any 193 personal legal rights you may have as a participant in this study.  
194 195 An Institutional Review Board responsible for research involving human subjects at The Ohio 196 State University reviewed this research project and found it to be acceptable, according to 197 applicable state and federal regulations and University policies designed to protect the rights 198 and welfare of research participants 199 200
Clinical trial: NCT05236894
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 77 **Risks And Benefits:**|80 **Risks And Benefits:**

78 79 Every attempt will be made to reduce risk to you. Nicotine pouches are no more harmful than 80 cigarettes and may even be less harmful. Questionnaires and blood collection involve minimal 81 risk to you. The IV placed is similar to a routine blood draw that would be performed for a 82 clinic visit. Potential risks are as follows: risk of using nicotine pouches, use of cigarettes, loss 83 of confidentiality or privacy, potential for interrupting your plans to quit smoking, and slight 84 risk of discomfort, bruising and infection with blood draw.  
85 86 You are not expected to directly gain any benefits from this study. Through your contributions 87 to science, you provide insight into a new tobacco product that has potential to impact tobacco 88 use in Ohio Appalachia and surrounding rural areas. Moreover, data collected will inform 89 public health efforts, policy, and clinical care in this region.  
90 91 While this trial is not without risk, every effort will be taken to reduce risk and undue burden 92 on participants.  
93 94 Participating in this study might make it harder to quit smoking. If you plan to quit smoking 95 in the next 3 months, you should not enroll in this study. We do not want to ask smokers who 96 want to quit to continue smoking. Please ask our PI about any questions you may have about 97 nicotine pouches, smoking, or smoking cessation.  
98 99 Study product or cigarette use: It is important to note that nicotine pouches are no more 100 harmful than cigarettes. If at any point you are uncomfortable with using the nicotine pouch, 101 please notify study staff immediately.  
102 103 Slight risk of bruising, discomfort and infection with blood draw: Blood will be collected by 104 trained research staff. Sterile instruments will be used and for blood draws, the participants 105 skin will be cleaned with an alcohol wipe at the venipuncture site.  
106 107 Breach of confidentiality: All information linking your name to the study will be stored in our 108 secure platform, REDCap or in a locked filing cabinet. You will be given a participant ID and 109 all information collected will be stored under that ID. Your study information will be stored in 110 the secure database, REDCap. Only trained members of the study team will have access to 111 your data. Moreover, any paper documents regarding your visit will be stored in a locked 112 filing cabinet with keys kept by the study PI and manager. Finally, your blood samples will be 113 deidentified - meaning including your participant ID and not your name - and stored in a 114 freezer in a locked room. While a breach of confidentiality is possible through hacking or 115 another means of forced entry, we believe the risk is low.  
116 117 If you experience any bad reactions or issues as a result of this study, please report to our 118 trained research nurse and study staff and, if severe, seek treatment immediately. Any 119 treatment you seek as a result of this study will be covered by you.  
120 121 122 **Confidentiality:**
123 124 We will work to make sure that no one sees your online responses without approval. But, 125 because we are using the Internet, there is a chance that someone could access your online 126 responses without permission. In some cases, this information could be used to identify you.  
127 128 Confidentiality will be maintained by numerically coding all data, disguising identifying 129 information, and keeping data locked in file drawers or in a secure, password protected 130 database. All biospecimen samples are kept in a locked freezer and also will be deidentified. 131 Names of participants will be kept separate from participant data. Only study staff will have 132 the information that connects participants' names and ID numbers. All electronic data will be 133 numerically coded and stored in a password-protected database, on a password-protected 134 computer in a secure research space. Participant information will be accessible only to 135 research staff, who are pledged to confidentiality and have completed training in the ethical 136 conduct of research. Identifying information will not be reported in any publications.  
137 138 Also, there may be circumstances where this information must be released. For example, 139 personal information regarding your participation in this study may be disclosed if required by 140 state law. Also, your records may be reviewed by the following groups (as applicable to the 141 research): 142 x Office for Human Research Protections or other federal, state, or international 143 regulatory agencies; 144 x The Ohio State University Institutional Review Board or Office of Responsible 145 Research Practices; 146 x Authorized Ohio State University staff not involved in the study may be aware that 147 you are participating in a research study and have access to your information; and 148 x The sponsor, if any, or agency (including the Food and Drug Administration for FDA149 regulated research) supporting the study.  
150 151 Your de-identified information may be used or shared with other researchers without your 152 additional informed consent. Your deidentified blood samples may be sent to an outside lab 153 for analysis. Your name would never be connected with the sample.  
154 155 We will not recontact you every time we use your sample or data from the questionnaires for 156 analysis.  
157 158 **Future Research:**
159 160 You will be given the option to be contacted for future, related studies.  
161 162 Your selection for being contacted about related studies will not impact your eligibility for 163 this study.  
164 165 166 **Incentives:**
167 By law, payments to participants are considered taxable income. You may receive up to $500 168 for your participation. After each visit, you will receive $150 on a pre-paid ClinCard. If you 169 complete all of your visits in a month, you will receive a $50 bonus at the end of your third 170 visit. If you complete baseline surveys but do not complete the blood draw portion of the visit, 171 we will provide a $50 pre-paid ClinCard to thank you for your time.  
172 173 174 **Participant Rights:** 175 You may refuse to participate in this study without penalty or loss of benefits to which you 176 are otherwise entitled. If you are a student or employee at Ohio State, your decision will not 177 affect your grades or employment status.  
178 206 207 208

81 82 Every attempt will be made to reduce risk to you. Nicotine pouches are no more harmful than 83 cigarettes and may even be less harmful. Questionnaires and blood collection involve minimal 84 risk to you. The IV placed is similar to a routine blood draw that would be performed for a 85 clinic visit. Potential risks are as follows: risk of using nicotine pouches, loss of 86 confidentiality or privacy, potential for interrupting your plans to quit smoking, and slight risk 87 of discomfort, bruising and infection with blood draw.  
88 89 You are not expected to directly gain any benefits from this study. Through your contributions 90 to science, you provide insight into a new tobacco product that has potential to impact tobacco 91 use in Ohio Appalachia. Moreover, data collected will inform public health efforts, policy, 92 and clinical care in this region.  
93 94 While this trial is not without risk, every effort will be taken to reduce risk and undue burden 95 on participants.  
96 97 Participating in this study might make it harder to quit smoking. If you plan to quit smoking 98 in the next 3 months, you should not enroll in this study. We do not want to ask smokers who 99 want to quit to continue smoking. Please ask our PI about any questions you may have about 100 nicotine pouches, smoking, or smoking cessation.  
101 102 Study product use: It is important to note that nicotine pouches are no more harmful than 103 cigarettes. If at any point you are uncomfortable with using the nicotine pouch, please notify 104 study staff immediately.  
105 106 Slight risk of bruising, discomfort and infection with blood draw: Blood will be collected by 107 trained research staff. Sterile instruments will be used and for blood draws, the participants 108 skin will be cleaned with an alcohol wipe at the venipuncture site.  
109 110 Breach of confidentiality: All information linking your name to the study will be stored in our 111 secure platform, REDCap or in a locked filing cabinet. You will be given a participant ID and 112 all information collected will be stored under that ID. Your study information will be stored in 113 the secure database, REDCap. Only trained members of the study team will have access to 114 your data. Moreover, any paper documents regarding your visit will be stored in a locked 115 filing cabinet with keys kept by the study PI and manager. Finally, your blood samples will be 116 deidentified - meaning including your participant ID and not your name - and stored in a 117 freezer in a locked room. While a breach of confidentiality is possible through hacking or 118 another means of forced entry, we believe the risk is low.  
119 120 If you experience any bad reactions or issues as a result of this study, please report to our 121 trained research nurse and study staff and, if severe, seek treatment immediately. Any 122 treatment you seek as a result of this study will be covered by you.  
123 124
Clinical trial: NCT05236894
Section: Purpose of Research
Subsections: 11 **The Ohio State University Consent To Participate In Research** 12 13 Study Title: Examining The Appeal Of Nicotine Pouches In Ohio Appalachia|12 **The Ohio State University Consent To Participate In Research** 13 14 Study Title: Examining The Appeal Of Nicotine Pouches In Ohio Appalachia

Protocol Number: 2021C0199 Researcher: Brittney Keller-Hamilton, PhD, MPH Sponsor: The Ohio State University 14 15 16 **This is a consent form for research participation.** It contains important information about 17 this study and what to expect if you decide to participate.

Protocol Number: 2021C0199 Researcher: Brittney Keller-Hamilton, PhD, MPH Sponsor: The Ohio State University 15 16 17 **This is a consent form for research participation.** It contains important information about 18 this study and what to expect if you decide to participate.
Clinical trial: NCT05236894
Section: Voluntary Participation
Subsections: 18 **Your Participation Is Voluntary.**|19 **Your Participation Is Voluntary.**

19 Please consider the information carefully. Feel free to ask questions before making your 20 decision whether or not to participate. Your participation in this research study will not impact 21 your affiliation with The Ohio State University in any capacity. You may withdraw from the 22 study at any time.  
23 24 **Purpose:** 25 Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for 26 cigarettes and are gaining in popularity. They may make a big impact in regions of Ohio 27 known as Appalachia and surrounding rural areas. There is little research on how nicotine 28 pouches will be adopted by residents of Ohio Appalachia and rural Ohio. We want to better 29 understand the appeal and potential impact of nicotine pouches on public health.  
30 31 We ask participants to provide blood samples for nicotine content analysis, which will show 32 us how much nicotine is absorbed by your bloodstream as you use nicotine pouches or smoke.  
33 This is very helpful for us to understand how nicotine is absorbed by the body. Additionally, 34 the questionnaires you answer will help us understand how and when you became a smoker, 35 how much you like or dislike the nicotine pouches, and also how you feel while using nicotine 36 pouches or cigarettes. There are two groups enrolling into this study. Participants enrolled in 37 Aim 1 are from Ohio Appalachia and surrounding rural areas and participants enrolled into 38 Aim 2 can be from anywhere in Ohio. You are enrolling into Aim 1, which focuses on the 39 differences between nicotine pouches and cigarettes. Participants can only enroll in one aim 40 and not both.  
41 42 **Procedures/Tasks:** 43 This study will enroll 40 adult cigarette smokers from Ohio Appalachia and surrounding rural 44 areas in Ohio.  
45 46 We invite participants to visit our lab for 3 study visits. If transportation to our lab is a 47 challenge, transportation via Lyft services may be available to you for two out of threeof your 48 study visits. You will be asked to abstain from all tobacco products for 12 hours before each 49 visit to provide the study team with a baseline value of the nicotine levels in your blood. 50 During each visit, you will be randomly assigned to smoke your usual brand of cigarettes or 51 try a nicotine pouch provided by the study. You will smoke for 5 minutes or keep the nicotine 52 pouch in your mouth for 30 minutes. During this time, research staff will ask a series of 53 questions and perform 7 blood draws.  
54 55 During each visit, you will have an IV placed in one of your arms to make the series of blood 56 draws less invasive. 3mL, or a little less than 1 teaspoon, of blood will be drawn at 7 intervals 57 over the course of 90 minutes. The IV will be placed and blood draws will be performed by a 58 trained research nurse.  
59 60 At the beginning of each visit, participants who are capable of becoming pregnant will be 61 asked to take a urine pregnancy test. If you are found to be pregnant, you will be withdrawn 62 from the study.  
63 64 65 **Duration:** 66 This study involves 3 study visits. The study timeline for each participant will vary, however, 67 each visit will take place 2 or more days after the previous visit and ideally within 2 weeks. 68 We ask participants to complete all 3 visits within two months of enrollment.  
69 70 Each study visit is expected to take about 3 hours.  
71 72 You may leave the study at any time. If you decide to stop participating in the study, there 73 will be no penalty to you, and you will not lose any benefits to which you are otherwise 74 entitled. Your decision will not affect your future relationship with The Ohio State 75 University.  
76

20 Please consider the information carefully. Feel free to ask questions before making your 21 decision whether or not to participate. Your participation in this research study will not impact 22 your affiliation with The Ohio State University in any capacity. You may withdraw from the 23 study at any time.  
24 25 **Purpose:** 26 Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for 27 cigarettes and are gaining in popularity. They may make a big impact in Ohio. There is little 28 research on how nicotine pouches will be adopted. We want to better understand the appeal 29 and potential impact of nicotine pouches on public health. There are two groups enrolling into 30 this study. Participants enrolled in Aim 1 are from Ohio Appalachia and participants enrolled 31 into Aim 2 can be from anywhere in Ohio. You are enrolling into Aim 2, which focuses on 32 the differences between tobacco-derived and synthetic nicotine pouches. Participants can only 33 enroll in one aim and not both.  
34 35 We ask participants to provide blood samples for nicotine content analysis, which will show 36 us how much nicotine is absorbed by your bloodstream as you use nicotine pouches. This is 37 very helpful for us to understand how nicotine is absorbed by the body. Additionally, the 38 questionnaires you answer will help us understand how and when you became a smoker, how 39 much you like or dislike the nicotine pouches, and also how you feel while using nicotine 40 pouches.  
41 42 **Procedures/Tasks:** 43 This study will enroll 20 adult cigarette smokers from Ohio.  
44 45 We invite participants to visit our lab for 3 study visits. You will be asked to abstain from all 46 tobacco products for 12 hours before each visit to provide the study team with a baseline 47 value of the nicotine levels in your blood. During each visit, you will be randomly assigned to 48 try a nicotine pouch provided by the study that contains either tobacco-derived or synthetic 49 nicotine. All nicotine pouches used in this study can be purchased online or at stores. In other 50 words, we did not make the nicotine pouches. You will keep the nicotine pouch in your mouth 51 for 30 minutes. During this time, research staff will ask a series of questions and perform 7 52 blood draws.  
53 54 During each visit, you will have an IV placed in one of your arms to make the series of blood 55 draws less invasive. 3mL, or a little less than 1 teaspoon, of blood will be drawn at 7 intervals 56 over the course of 90 minutes. The IV will be placed and blood draws will be performed by a 57 trained research nurse.  
58 59 At the beginning of each visit, participants who are capable of becoming pregnant will be 60 asked to take a urine pregnancy test. If you are found to be pregnant, you will be withdrawn 61 from the study.  
62 63 You will be asked to try a nicotine pouch during each visit. As a participant, you will be asked 64 to try 3 different types of nicotine pouches in random order. They are all FDA-approved and 65 available in stores. Products include: Zyn wintergreen 3mg (tobacco-derived nicotine), a Fre 66 wintergreen 3mg (synthetic nicotine), and a Niin wintergreen 3mg (synthetic nicotine).  
67 68 **Duration:** 69 This study involves 3 study visits. The study timeline for each participant will vary, however, 70 each visit will take place 2 or more days after the previous visit and ideally within 2 weeks. 71 We ask participants to complete all 3 visits within two months of enrollment.  
72 73 Each study visit is expected to take about 3 hours.  
74 75 You may leave the study at any time. If you decide to stop participating in the study, there 76 will be no penalty to you, and you will not lose any benefits to which you are otherwise 77 entitled. Your decision will not affect your future relationship with The Ohio State 78 University.  
79