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

NCT06249984 | Recruiting DMC

• 3 other identifiers: OSU-22228NCI-2023-01289K01DA055696
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (11)

• Frequencies of flavors used by participants

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

  Up to 2 years

• 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.

  Up to 2 years

• 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.

  Up to 2 years

• 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.

  Up to 2 years

• Associations between level of dependence and free-base nicotine (FBN) 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 FBN in moist snuff.

  Up to 2 years

• Moist snuff tobacco cut 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 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.

  Up to 2 years

• 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.

  Up to 2 years

• 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.

  Up to 2 years

• 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.

  Up to 2 years

• 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.

  Up to 2 years

• Moist snuff tobacco FBN content 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 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.

  Up to 2 years

Study Arms (5)

Prevention (Smokeless tobacco use: Usual Brand)

PLACEBO COMPARATOR

Participants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

Prevention (Smokeless tobacco use: Low FBN Long Cut)

ACTIVE COMPARATOR

Participants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

Prevention (Smokeless tobacco use: Low FBN Fine Cut)

ACTIVE COMPARATOR

Participants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

Prevention (Smokeless tobacco use: High FBN Long Cut)

ACTIVE COMPARATOR

Participants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

Prevention (Smokeless tobacco use: High FBN Fine Cut)

ACTIVE COMPARATOR

Participants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

Interventions

Carbon Monoxide Measurement PROCEDURE

Undergo CO test

Also known as: Carbon Monoxide, CMONOX

Prevention (Smokeless tobacco use: High FBN Fine Cut); Prevention (Smokeless tobacco use: High FBN Long Cut); Prevention (Smokeless tobacco use: Low FBN Fine Cut); Prevention (Smokeless tobacco use: Low FBN Long Cut); Prevention (Smokeless tobacco use: Usual Brand)

Smokeless Tobacco Use BEHAVIORAL

Use moist snuff

Also known as: Tobacco, Smokeless

Prevention (Smokeless tobacco use: High FBN Fine Cut); Prevention (Smokeless tobacco use: High FBN Long Cut); Prevention (Smokeless tobacco use: Low FBN Fine Cut); Prevention (Smokeless tobacco use: Low FBN Long Cut); Prevention (Smokeless tobacco use: Usual Brand)

Survey Administration OTHER

Ancillary studies

Prevention (Smokeless tobacco use: High FBN Fine Cut); Prevention (Smokeless tobacco use: High FBN Long Cut); Prevention (Smokeless tobacco use: Low FBN Fine Cut); Prevention (Smokeless tobacco use: Low FBN Long Cut); Prevention (Smokeless tobacco use: Usual Brand)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Prevention (Smokeless tobacco use: High FBN Fine Cut); Prevention (Smokeless tobacco use: High FBN Long Cut); Prevention (Smokeless tobacco use: Low FBN Fine Cut); Prevention (Smokeless tobacco use: Low FBN Long Cut); Prevention (Smokeless tobacco use: Usual Brand)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• AIM 2: As derived from Aim 1, commercially available SLT products used by TUAC and BTHS participants will be purchased from retailers in nearby Appalachian counties, as composition of SLT products can vary regionally
• AIM 3: 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
• Willing to complete 5 study visits and provide informed consent study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
• Willing to abstain from nicotine and tobacco products 12-hours before study visit
• Ability to read and speak English

You may not qualify if:

• 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
• Severe periodontal or oral lesions

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Center for Tobacco Research

Columbus, Ohio, 43214, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Specimen Handling; Carbon Monoxide; Tobacco, Smokeless

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Tobacco Products; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Brittney L Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinded study products
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Within-subjects factorial design

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)