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Tobacco-Related CarcinomaNCT06249984

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

A study testing Biospecimen Collection, Carbon Monoxide Measurement and Smokeless Tobacco Use in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco-Related Carcinoma
What is being tested?
Biospecimen Collection, Carbon Monoxide Measurement and Smokeless Tobacco Use
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
20 Dec 2024to 31 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States2 sites, 2 recruiting
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Brittney L. Keller-Hamilton, Phd, MPH, 614-366-9652, keller-hamilton.1@osu.edu

    Brittney L. Keller-Hamilton, Phd, MPH

    Not yet recruiting
  • Center for Tobacco Research

    Columbus, Ohio, 43214

    Hayley Curran, MPH, 7402818555, curran.144@osu.edu

    Brittney Keller-Hamilton, PhD, 7402818555, bkh-lab@osumc.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Carbon Monoxide Measurement, Smokeless Tobacco Use, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Carbon Monoxide MeasurementProcedure or surgery

    Also called Carbon Monoxide, CMONOX

    Undergo CO test

  • Smokeless Tobacco UseBehavioural

    Also called Tobacco, Smokeless

    Use moist snuff

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06249984
Study groupRoleWhat they receive
Prevention (Smokeless tobacco use: Usual Brand)Placebo comparatorParticipants use their usual brand of moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration
Prevention (Smokeless tobacco use: Low FBN Long Cut)Active comparatorParticipants use low FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration
Prevention (Smokeless tobacco use: Low FBN Fine Cut)Active comparatorParticipants use low FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration
Prevention (Smokeless tobacco use: High FBN Long Cut)Active comparatorParticipants use high FBN long cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration
Prevention (Smokeless tobacco use: High FBN Fine Cut)Active comparatorParticipants use high FBN fine cut moist snuff on study. Participants also undergo blood sample collection and carbon monoxide testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Behavioral: Smokeless Tobacco Use; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

  4. 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.

    Measured: Up to 2 years

  5. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start20 Dec 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Within-subjects factorial design
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249984
Sponsor's protocol ID
OSU-22228
Other IDs
NCI-2023-01289, K01DA055696
Status last verified
Aug 2026
First submitted
22 Jan 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Carbon Monoxide Measurement and Smokeless Tobacco Use in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moist snuff tobacco FBN content on product use (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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