Examining the Appeal of Nicotine Pouches in Ohio Appalachia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Evaluate plasma nicotine concentration at t=30 minutes for each product.
研究概览
简要总结
This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.
详细描述
Aim 1:
PRIMARY OBJECTIVE:
I. To estimate the abuse liability of nicotine pouches (NPs) with varying nicotine concentrations relative to cigarette smoking.
SECONDARY OBJECTIVE:
I. To clarify the public health effect of NPs in Appalachian Ohio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 years or older.
- •Reside in an Ohio Appalachian county.
- •Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.
- •Ability to read and speak English.
- •Smoke at least 5 cigarettes per day for the past 30 days.
排除标准
- •Use tobacco products other than cigarettes >10 days per month.
- •Use NP in the past 3 months.
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed).
- •Pregnant, planning to become pregnant, or breastfeeding.
- •History of cardiac event or distress within the past 3 months.
- •Currently attempting to quit all tobacco use.
- •Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.
- •Aim 2 Inclusion Criteria:
- •Age 21 years or older.
- •Reside in a Ohio.
- •Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.
- •Ability to read and speak English.
- •Smoke at least 5 cigarettes per day for the past 30 days.
- •Exclusion Criteria:
- •Use tobacco products other than cigarettes >10 days per month.
- •Use NP in the past 3 months.
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed).
- •Pregnant, planning to become pregnant, or breastfeeding.
- •History of cardiac event or distress within the past 3 months.
- •Currently attempting to quit all tobacco use.
- •Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.
研究组 & 干预措施
Aim 1: Arm I (lower dose nicotine pouch)
Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Nicotine Oral Pouch (Drug)
Aim 1: Arm I (lower dose nicotine pouch)
Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 1: Arm II (higher dose nicotine pouches)
Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Nicotine Oral Pouch (Drug)
Aim 1: Arm II (higher dose nicotine pouches)
Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 1: Arm III (cigarette smoking)
Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.
干预措施: Cigarette Smoking (Behavioral)
Aim 1: Arm III (cigarette smoking)
Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 2: Arm I (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 2: Arm I (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Nicotine Oral Pouch (Drug)
Aim 2: Arm II (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 2: Arm II (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Nicotine Oral Pouch (Drug)
Aim 2: Arm III (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Questionnaire Administration (Other)
Aim 2: Arm III (3mg NP)
Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
干预措施: Nicotine Oral Pouch (Drug)
结局指标
主要结局
Evaluate plasma nicotine concentration at t=30 minutes for each product.
时间窗: Up to 6 months
次要结局
- Evaluate plasma nicotine concentrations at t=5 through t=90 minutes(Up to 6 months)
- Evaluate withdrawal relief at t=5 through t=90 minutes(Up to 6 months)
- Evaluate product appeal across all 3 products(Up to 6 months)
- Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking(Up to 6 months)
研究者
Brittney Keller-Hamilton
Principal Investigator
Ohio State University Comprehensive Cancer Center