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
Adults aged 21 and older who reside in Appalachian counties and surrounding rural areas under the RUCA code 10 classification and use SLT daily for at least 3 months and using 1.5 cans/week will be considered for this project
Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week.
Age 21 years or older
Reside in Appalachian counties and surrounding rural areas under the RUCA code 10 classification
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
Moist snuff tobacco FBN content on product use
Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of FBN content on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence.
Moist snuff tobacco cut on product effects
Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of cut on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence.
Moist snuff tobacco FBN content on product effects
Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of FBN content on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence.
Moist snuff tobacco cut on product appeal
Will be assessed by a randomized 2x2 within-subjects design to test whether variations in cut and level of FBN are associated with product use, nicotine delivery, and subjective effects among Appalachian moist snuff users. Data will be summarized descriptively, overall and stratified by dependence. The investigators will use linear mixed effects models to assess the main effects of cut on moist snuff use duration and amount, self-reported measures, and plasma nicotine delivery (i.e., maximum absorption; total absorption; and speed of absorption). Product interaction terms will be used to evaluate whether effects of moist snuff style on outcome variables are modified by level of SLT dependence.
Sponsors and contacts
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Ohio State University Comprehensive Cancer Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator