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

NCT ID: NCT06249984

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within-subjects factorial design
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Blinded study products

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo CO test

Smokeless Tobacco Use

Intervention Type BEHAVIORAL

Use moist snuff

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo CO test

Smokeless Tobacco Use

Intervention Type BEHAVIORAL

Use moist snuff

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo CO test

Smokeless Tobacco Use

Intervention Type BEHAVIORAL

Use moist snuff

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo CO test

Smokeless Tobacco Use

Intervention Type BEHAVIORAL

Use moist snuff

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type PLACEBO_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo CO test

Smokeless Tobacco Use

Intervention Type BEHAVIORAL

Use moist snuff

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Carbon Monoxide Measurement

Undergo CO test

Intervention Type PROCEDURE

Smokeless Tobacco Use

Use moist snuff

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Carbon Monoxide CMONOX Tobacco, Smokeless

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Brittney Keller-Hamilton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brittney L Keller-Hamilton, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status NOT_YET_RECRUITING

Center for Tobacco Research

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

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Brittney L. Keller-Hamilton, Phd, MPH

Role: primary

Hayley Curran, MPH

Role: primary

Brittney Keller-Hamilton, PhD

Role: backup

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2023-01289

Identifier Type: REGISTRY

Identifier Source: secondary_id

K01DA055696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-22228

Identifier Type: -

Identifier Source: org_study_id