This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.
Read and speak English
At least 21 years old
Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
Willing to attend all study visits and use study ONPs
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
History of cardiac event or distress within the past 3 months
Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit [acute use of usual product and study ONPs] and Phase 2 study visit 1 [distribution of study ONPs for outpatient ad libitum use])
Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample and oral mucosa sample collection
Cigarette
DrugSmoke usual brand cigarette
Nicotine Oral Pouch
DrugInsert low FBN R/S ONP
Nicotine Oral Pouch
DrugInsert low FBN \> 99% S ONP
Nicotine Oral Pouch
DrugInsert high R/S ONP
Nicotine Oral Pouch
DrugInsert high FBN \> 99% ONP
Smokeless Tobacco
DrugInsert ST
Survey Administration
Other interventionAncillary studies
Text Message-Based Navigation Intervention
Other interventionReceive text with a link to daily diary surveys
9
Treatment groupsSee each treatment group below.
Increased nicotine delivery
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of oral nicotine pouches (ONPs) relative to cigarettes and smokeless tobacco (ST). Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Liking
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Craving/withdrawal suppression
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Rate of switching to ONP
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
ONP and Tobacco Purchase Task
Data will be used to assess the prices participants would be willing to pay for each unit of product. Using demand curves generated from self-report data for each product, we will be able to determine how participants' usual brand compares to ONPs at different price points.
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Ohio State University Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
