Recruiting

Tobacco Cut & Nicotine Form

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06249984

Conditions

Tobacco-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Carbon Monoxide Measurement

Smokeless Tobacco Use

Survey Administration

Study Details

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

Study ID

NCT06249984

Start date

Dec 20, 2024

Status verified date

Aug, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Prevention (Smokeless tobacco use: Usual Brand)

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

active comparator: Prevention (Smokeless tobacco use: Low FBN Long Cut)

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

active comparator: Prevention (Smokeless tobacco use: Low FBN Fine Cut)

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

active comparator: Prevention (Smokeless tobacco use: High FBN Long Cut)

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

active comparator: Prevention (Smokeless tobacco use: High FBN Fine Cut)

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

Interventions

Biospecimen Collection

Undergo blood sample collection

Carbon Monoxide Measurement

Undergo CO test

Smokeless Tobacco Use

Use moist snuff

Survey Administration

Ancillary studies

Primary outcome measure

  • Moist snuff tobacco FBN content on product use [ Time Frame: Up to 2 years ]
  • Moist snuff tobacco cut on product effects [ Time Frame: Up to 2 years ]
  • Moist snuff tobacco FBN content on product effects [ Time Frame: Up to 2 years ]
  • Moist snuff tobacco cut on product appeal [ Time Frame: Up to 2 years ]
  • Moist snuff tobacco FBN content on product appeal [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Center for Tobacco Research

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Hayley Curran, MPH

7402818555curran.144@osu.edu

Brittney Keller-Hamilton, PhD

7402818555bkh-lab@osumc.edu

Principal Investigator:

Brittney Keller-Hamilton, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-17.