About this trial
This clinical trial tests the effects of tobacco cut and nicotine form on the abuse liability in participants who use moist snuff (smokeless tobacco \[SLT\]). Two features of moist snuff that are key targets of manipulation from the tobacco industry and drivers of its addiction potential are length of tobacco cut (long versus fine) and nicotine form (low versus high levels of nicotine in the free-base form). Finer tobacco cuts and higher levels of free-base nicotine (FBN) result in faster, greater nicotine delivery. Researchers want to gain information on how certain characteristics of moist snuff affect how long people use it, how it delivers nicotine, or how much people like it. This clinical trial may provide justifications for local, state, or federal regulations aimed at reducing the appeal and addictiveness of moist snuff.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
AIM 1 (Adults Tobacco User Adult Cohort [TUAC]): Exclusive adult smokers who smoked >100 cigarettes or other combustible tobacco products in their lifetime and reported being current, every day, or some days/week smokers at time of enrollment
AIM 1 (TUAC): Exclusive SLT user reporting every day or some days use per week at time of enrollment
AIM 1 (TUAC): Or dual users who met criteria for both aims at time of enrollment who resided in participating Appalachian and urban counties
AIM 1 (Buckeye Teen Health Study [BTHS]): Male youth ages 12-15 in Appalachian and urban regions of Ohio with parental consent and participant assent given
Disqualifiers
Pregnant, planning to become pregnant, or breastfeeding (will be verified with a urine pregnancy test at the first session visit)
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, and shortness of breath, within the past 3 months
Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months
Trial design
Crossover
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Carbon Monoxide Measurement
Procedure/SurgeryUndergo CO test
Smokeless Tobacco Use
BehavioralUse moist snuff
Survey Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Frequencies of flavors used by participants
Will be assessed in adolescent and adult participants (expected N=198). Will be evaluated using descriptive statistics
Associations between tobacco cut (fine, long, and pouches) and level of smokeless tobacco (SLT) dependence
Will use chi-square tests to estimate associations between tobacco cut (fine, long, and pouches) and level of SLT dependence. If the expected cell size for more than 20% of cells is \< 5, Fisher's exact test will be used.
Associations between level of dependence and total nicotine in moist snuff
Descriptive statistics will be calculated and variables will be inspected for out-of-range values. The investigators will merge product characteristics into our cohort study data (e.g., characteristics of Grizzly long cut wintergreen moist snuff will be merged to participants who reported using that style). Next, the investigators will use linear regression to estimate the associations between level of dependence and total nicotine.
Associations between level of dependence and pH in moist snuff
Descriptive statistics will be calculated and variables will be inspected for out-of-range values. The investigators will merge product characteristics into our cohort study data (e.g., characteristics of Grizzly long cut wintergreen moist snuff will be merged to participants who reported using that style). Next, the investigators will use linear regression to estimate the associations between level of dependence and pH.
Sponsors and contacts
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Ohio State University Comprehensive Cancer Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator