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

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

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

Frequencies of flavors used by participants

Will be assessed in adolescent and adult participants (expected N=198). Will be evaluated using descriptive statistics

Time frame
Up to 2 years
2

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.

Time frame
Up to 2 years
3

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.

Time frame
Up to 2 years
4

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.

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