This clinical trial investigates how nornicotine, a component that is present in smokeless tobacco products, is broken down and absorbed by the body. Nornicotine, a component that is present in usual smokeless tobacco products may be a precurser for carcinogen exposure, specifically N′-Nitrosonornicotine (NNN). Information from this study may help the Food and Drug Administration decide how best to regulate tobacco products with the goal of improving public health.
Additional locations may be listed on ClinicalTrials.gov for NCT03998735.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the variation of nornicotine content in smokeless products currently marketed in the United States (US).
II. To investigate endogenous formation of NNN in smokeless tobacco users.
OUTLINE: Participants will be assigned to 1 of 4 arms.
ARM I: Participants receive herbal snuff (smokeless tobacco) with the average amount of nornicotine found in commercial products orally (PO) 3 times over 6 hours.
ARM II: Participants receive smokeless tobacco with the lowest level of nornicotine found in commercial products PO 3 times over 6 hours.
ARM III: Participants receive smokeless tobacco with 5% of the lowest level of nornicotine found in commercial products PO 3 times over 6 hours.
ARM IV: Participants receive smokeless tobacco with no nornicotine added PO 3 times over 6 hours.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorIrina Stepanov