Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Carbon Monoxide Measurement

    Procedure/Surgery

    Undergo CO test

  • Smokeless Tobacco Use

    Behavioral

    Use moist snuff

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

80 Participants
are divided into 5 treatment groups
Group A: Prevention (Smokeless tobacco use: Usual Brand)Placebo comparator 4 interventions
Group B: Prevention (Smokeless tobacco use: Low FBN Long Cut)Active comparator 4 interventions
Group C: Prevention (Smokeless tobacco use: Low FBN Fine Cut)Active comparator 4 interventions
Group D: Prevention (Smokeless tobacco use: High FBN Long Cut)Active comparator 4 interventions
Group E: Prevention (Smokeless tobacco use: High FBN Fine Cut)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 years
2

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.

Time frame
Up to 2 years
3

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.

Time frame
Up to 2 years
4

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.

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ohio State University Comprehensive Cancer Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator