RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-20
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06249984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * AIM 1 (TUAC): Exclusive SLT user reporting every day or some days use per week at time of enrollment
  3. * AIM 1 (TUAC): Or dual users who met criteria for both aims at time of enrollment who resided in participating Appalachian and urban counties
  4. * 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
  5. * 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
  6. * AIM 3: Adults aged 21 and older who reside in an Ohio Appalachian county and use SLT at least 6x/day for at least 6 months will be considered for this project
  7. * Daily use (at least 6 dips/day) of moist snuff for at least 6 months
  8. * Age 21 years or older
  9. * Reside in an Ohio Appalachian county or surrounding rural area
  10. * 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
  11. * Willing to abstain from nicotine and tobacco products 12-hours before study visit
  12. * Ability to read and speak English
  1. * Pregnant, planning to become pregnant, or breastfeeding (will be verified with a urine pregnancy test at the first session visit)
  2. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
  3. * 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
  4. * Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months
  5. * Severe periodontal or oral lesions

Contacts and Locations

Study Contact

The Ohio State Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Brittney L Keller-Hamilton, PhD, MPH
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Center for Tobacco Research
Columbus, Ohio, 43214
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Brittney L Keller-Hamilton, PhD, MPH, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-12-20
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Tobacco-Related Carcinoma