Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia

Official title

Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia

Overview

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.

Detailed description

PRIMARY OBJECTIVES:

I. Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT.

II. Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT.

III. Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I:

SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.

SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks.

Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.

OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.

ARM II:

SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.

SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks.

Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.

OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.

Interventions

• Other Carbon Monoxide Measurement
  Undergo carbon monoxide measurement
• Other Nicotine Lozenge
  Use nicotine lozenge
• Other Oral Nicotine Pouch
  Use oral nicotine pouch
• Other Nicotine Patch
  Use nicotine patch
• Other Survey Administration
  measurements; data gathering
• Other Check-in Phone Calls
  Check-in phone calls to study participants

Primary outcome measures

• Biochemically verified 7-day point prevalence abstinence from cigarettes [Time frame: At the end of the 12- week switch phase]
• Complete switching rate (Aim 1) [Time frame: At the end of the 12-week switch phase]
• Abstinence from cigarettes (Aim 1) [Time frame: At the end of the 12-week switch phase]
• Cigarettes smoked per day (Aim 1) [Time frame: At the end of the 12-week switch phase]
• Differences in product appeal (Aim 2) [Time frame: From baseline to the end of the 12 week switch phase]
• Cigarette craving (Aim 2) [Time frame: Up to the end of the 12 week switch phase]
• Withdrawal symptoms (Aim 2) [Time frame: Up to the end of the 12 week switch phase]
• Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2) [Time frame: From baseline to the end of the 12 weeks switch phase]
• Abstinence from cigarettes (Aim 3) [Time frame: Up to the end of the 14 week observation phase]
• Number of days the study products are used (Aim 3) [Time frame: Up to the end of the 14 week observation phase]

Eligibility criteria

Inclusion criteria

• Read and speak English
• 21 years or older
• Smoke ≥ 5 cigarettes per day for the past year
• Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)
• Live in a rural Appalachian County
• Have a smartphone and/or willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only)
• Willing to blow air into a handheld study device
• If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results

Exclusion criteria

• Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
• Use of ONPs in past 3 months
• Use of Nicotine Replacement Therapies in past 3 months
• Use of other tobacco products > 10 days/month
• Unstable or significant medical condition
• Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• History of cardiac event or distress within the past 3 months
• Live in same household as another study participant.
• Currently pregnant, planning to become pregnant within 6 months, or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Ohio State University Comprehensive Cancer Center — Columbus

Publications

• Wermert A, Brasky TM, Newton AM, Hinton A, Curran H, Ferketich AK, Carpenter MJ, Shields PG, Tomko P, Wagener TL, Keller-Hamilton B. Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol. PLoS One. 2025 Dec 23;20(12):e0338503. doi: 10.1371/journal.pone.0338503. eCollection 2025. PMID 41433314

Identifiers

NCT: NCT06763536 · 2024C0064 · NCI-2024-09181 · R01CA289551-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗