THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.
This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.
详细描述
This investigation expands on the parent study's Aims 1 and 2 by examining the effects of a feature that the investigators have identified varies across nicotine pouches (ONP): particle size. The investigators expect that particle size differences may translate to differences in user experience. The investigators wish to further explore this hypothesis among current ONP users. Data will be captured over the course of 3 clinic visits and across two week-long switching periods with daily diary surveys. This will inform interpretation of results from Aims 1 and 2, including how to translate those findings to commercially-available nicotine pouches.
Aim 1: Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. ONPs with high FBN and >99% S-nicotine will have (H1a) increased satisfaction and appeal (e.g., faster nicotine delivery, greater liking). H1b: Associations of form and isomer with addiction potential and appeal will be strongest in the high nicotine concentration arm.
Aim 2: Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. Over 4 weeks, participants randomized to use ONPs with high FBN and >99% S-nicotine (vs. other ONPs) will report higher prevalence of (H2a) partially switching to ONPs (use ONPs >14 days but continued usual product use) and (H2b) complete switching to ONPs by week 4. H2c: Associations of form and isomer with switching outcomes will be strongest in the high nicotine concentration arm.
Study Procedures:
Participants will complete three in-person visits. Visits involve randomized, double-blinded use of either small-particle ONPs or a distribution of particle-size ONPs (one assigned product per visit).
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
- Double (Participant, Investigator)
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 or older
- •Able to read and speak English
- •Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits
- •Exclusive use of ONPs (other product use <10x/mo).
- •Exhaled CO reading <10 ppm
- •Owns a smartphone and can receive SMS text messages with embedded survey links
- •Negative pregnancy test at V1 and V2 (if applicable)
- •Uses ≥1.5 cans of ONPs/week
- •Daily use of ONPs for the past 3 months
- •At least half of ONPs used are 6mg nicotine concentration.
排除标准
- •Non-English speaker
- •Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).
- •Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.
- •Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts
- •Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.
研究组 & 干预措施
Variable particle size oral nicotine pouches
CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Survey Administration (Other)
Small particle size oral nicotine pouches
CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Nicotine Oral Pouch (Drug)
Variable particle size oral nicotine pouches
CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Nicotine Oral Pouch (Drug)
Small particle size oral nicotine pouches
CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Biospecimen Collection (Procedure)
Small particle size oral nicotine pouches
CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Survey Administration (Other)
Small particle size oral nicotine pouches
CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Text Message-Based Navigation Intervention (Other)
Variable particle size oral nicotine pouches
CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Biospecimen Collection (Procedure)
Variable particle size oral nicotine pouches
CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.
干预措施: Text Message-Based Navigation Intervention (Other)
研究者
Brittney Keller-Hamilton
Principal Investigator
Ohio State University Comprehensive Cancer Center