Clinical trial NCT06763536: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Biochemically verified 7-day point prevalence abstinence from cigarettes
timeFrame: At the end of the 12- week switch phase
measure: Complete switching rate (Aim 1)
timeFrame: At the end of the 12-week switch phase
measure: Abstinence from cigarettes (Aim 1)
timeFrame: At the end of the 12-week switch phase
measure: Cigarettes smoked per day (Aim 1)
timeFrame: At the end of the 12-week switch phase
measure: Differences in product appeal (Aim 2)
timeFrame: From baseline to the end of the 12 week switch phase
measure: Cigarette craving (Aim 2)
timeFrame: Up to the end of the 12 week switch phase
measure: Withdrawal symptoms (Aim 2)
timeFrame: Up to the end of the 12 week switch phase
measure: Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2)
timeFrame: From baseline to the end of the 12 weeks switch phase
measure: Abstinence from cigarettes (Aim 3)
timeFrame: Up to the end of the 14 week observation phase
measure: Number of days the study products are used (Aim 3)
timeFrame: Up to the end of the 14 week observation phase
measure: Purchase and continued use of the study products (Aim 3)
timeFrame: Up to the end of the 14 week observation phase
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brittney L Keller-Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: