What is the purpose of this study?
The purpose of this study is to better understand how nornicotine, a component that is present in your usual smokeless tobacco product, is broken down and absorbed by the body.
How often are clinic visits?
There will be six visits over the course of approximately 3 weeks.
What will I be doing in the study?
For the first visit, the screening session, we will set up a virtual visit using a secured video-conferencing link. We ask that you show us a tin of your usual brand tobacco, all of your prescription medications, and identification during this visit. We will complete several questionnaires. You must be comfortable reading and answering questions in order to participate in this study.
If you are eligible after the screening procedures we will ask you to complete 5 additional visits. We will ask you to come back to the clinic and we will ask you to use a pouch of study snuff for 30 minutes. During this time, we will ask you to spit, as needed, into a collection container. We will repeat this two more times with one hour in between pouches. This visit will last about 6 hours. We will send two large urine containers home with you and ask you to collect a 24-hour urine sample, starting with the first void after using the first study snuff pouch. You will be asked to return the 24-hour urine sample to the clinic the next day. We will collect your vital signs and ask you if there have been any changes to your health since your last visit. This visit will take approximately 30 minutes. We will ask you to collect 24-hour urine samples and return them to the clinic for two more days.
The study snuff that we will ask you to use during the lab visits does not contain tobacco but is a commercially available herbal snuff. We have modified this snuff by adding various levels of nornicotine and a small amount of nitrosonornicotine (NNN), both of which are present in regular tobacco products.
The nornicotine we have added is called [pyridine-D4]nornicotine. This is the same as the nornicotine in regular tobacco, except that we have added 4 deuterium atoms (heavy hydrogen) and this label allows us to follow how your system breaks down nornicotine. Deuterium is non-radioactive and safe. The amount of [pyridine-D4]nornicotine added to the study herbal snuff can be higher or lower than the amount in your own smokeless tobacco product, but not higher than what can be normally found in regular smokeless products sold in stores. Therefore, when you use the study snuff we provide, there will be no additional risk compared to your usual smokeless tobacco brand.
Will I be compensated?
Participants will be paid up to $200.
What should I do if I'm interested?
For more information, call or email the University of Minnesota’s Tobacco Research Programs:
Samantha
(612) 624-5286
[email protected]
Or complete our online survey to see if you qualify: https://redcap.link/gobicaep