NCT06249984 Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
| NCT ID | NCT06249984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Tobacco-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-12-20 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Brittney L Keller-Hamilton, PhD, MPH
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06249984 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Tobacco-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06249984 currently recruiting?
Yes, NCT06249984 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT06249984 trial being conducted?
This trial is being conducted at Columbus, United States, Columbus, United States.
Who is sponsoring the NCT06249984 clinical trial?
NCT06249984 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Brittney L Keller-Hamilton, PhD, MPH at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 80 participants.