Clinical trial NCT06249984: Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
Official title: Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subjects factorial design
Primary purpose: PREVENTION

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.

Detailed 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.

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 an Ohio Appalachian county and use SLT at least 6x/day for at least 6 months will be considered for this project
* Daily use (at least 6 dips/day) of moist snuff for at least 6 months
* Age 21 years or older
* Reside in an Ohio Appalachian county or surrounding rural area
* 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

Primary outcomes:
measure: Frequencies of flavors used by participants
timeFrame: Up to 2 years
measure: Associations between tobacco cut (fine, long, and pouches) and level of smokeless tobacco (SLT) dependence
timeFrame: Up to 2 years
measure: Associations between level of dependence and total nicotine in moist snuff
timeFrame: Up to 2 years
measure: Associations between level of dependence and pH in moist snuff
timeFrame: Up to 2 years
measure: Associations between level of dependence and free-base nicotine (FBN) in moist snuff
timeFrame: Up to 2 years
measure: Moist snuff tobacco cut on product use
timeFrame: Up to 2 years
measure: Moist snuff tobacco FBN content on product use
timeFrame: Up to 2 years
measure: Moist snuff tobacco cut on product effects
timeFrame: Up to 2 years
measure: Moist snuff tobacco FBN content on product effects
timeFrame: Up to 2 years
measure: Moist snuff tobacco cut on product appeal
timeFrame: Up to 2 years
measure: Moist snuff tobacco FBN content on product appeal
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Center for Tobacco Research
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brittney L Keller-Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: