Recruiting NA Tobacco-Related Carcinoma

New treatment option for Tobacco-Related Carcinoma

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

ClinicalTrials.gov ID: NCT06249984

What this study is testing

What it's testing
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).
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 21 and older. Healthy volunteers may be eligible.

You may be able to join if

  • AIM 1 (Adults Tobacco User Adult Cohort [TUAC]): Exclusive adult smokers who smoked \>100 cigarettes or other combustible tobacco products in their...
  • 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...
  • AIM 2: As derived from Aim 1, commercially available SLT products used by TUAC and BTHS participants will be purchased from retailers in nearby...

You likely can't join if

  • 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...
  • 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
See the full eligibility criteria
Who can join
  • 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...
  • 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...
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Columbus, Ohio, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.