Effects of Tobacco Cut & Nicotine Form on the Abuse Liability of Moist

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Estimate the association between style of moist snuff and SLT addiction among Ohio Appalachian adolescents and adults. II. Characterize the carcinogen and free-base nicotine content of SLT products used by adolescents and adults with varying levels of SLT dependence in Ohio Appalachia. III. Assess effects of moist snuff tobacco cut and FBN content on product use, effects, and appeal among Appalachian adults with high versus (vs.) low SLT dependence. OUTLINE: Participants attend 5 study visits in a randomized order. VISIT I: Participants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. VISIT II: Participants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. VISIT III: Participants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. VISIT IV: Participants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. VISIT V: Participants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study. ;

Study Design

Related Conditions & MeSH terms

Tobacco-Related Carcinoma

Clinical Trial Details

NCT number	NCT06249984
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact	The Ohio State Comprehensive Cancer Center
Phone	800-293-5066
Email	OSUCCCClinicaltrials@osumc.edu
Status	Not yet recruiting
Phase	N/A
Start date	March 1, 2024
Completion date	December 31, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms