Informing Oral Nicotine Pouch Regulations to Promote Public Health
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Increased nicotine delivery
研究概览
简要总结
This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.
详细描述
PRIMARY OBJECTIVES:
I. Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST.
II. Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs.
EXPLORATORY OBJECTIVE:
I. Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettes/ST to ONPs.
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
- 否
入选标准
- •Read and speak English
- •At least 21 years old
- •Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
- •Willing to attend all study visits and use study ONPs
- •Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)
- •Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
- •Exhaled carbon monoxide (CO) reading < 10 (Phase 1)
- •CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)
- •ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week (as in Pickworth et al., 2014)
排除标准
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- •History of cardiac event or distress within the past 3 months
- •Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit [acute use of usual product and study ONPs] and Phase 2 study visit 1 [distribution of study ONPs for outpatient ad libitum use])
- •Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
- •Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)
- •CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days
- •CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
- •CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers
- •ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days
研究组 & 干预措施
PHASE I ARM III (high FBN R/S ONP)
Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Nicotine Oral Pouch (Drug)
PHASE I ARM V (Usual brand ST or cigarette)
Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
干预措施: Cigarette (Drug)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Smokeless Tobacco (Drug)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Biospecimen Collection (Procedure)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Text Message-Based Navigation Intervention (Other)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Biospecimen Collection (Procedure)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Survey Administration (Other)
PHASE I ARM I (low FBN R/S ONP)
Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Cigarette (Drug)
PHASE I ARM I (low FBN R/S ONP)
Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Survey Administration (Other)
PHASE I ARM II (low FBN > 99% S ONP)
Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Cigarette (Drug)
PHASE I ARM II (low FBN > 99% S ONP)
Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Survey Administration (Other)
PHASE I ARM III (high FBN R/S ONP)
Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Biospecimen Collection (Procedure)
PHASE I ARM III (high FBN R/S ONP)
Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Survey Administration (Other)
PHASE I ARM IV (high FBN > 99% ONP)
Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Biospecimen Collection (Procedure)
PHASE I ARM IV (high FBN > 99% ONP)
Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Cigarette (Drug)
PHASE I ARM V (Usual brand ST or cigarette)
Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
干预措施: Biospecimen Collection (Procedure)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Cigarette (Drug)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Text Message-Based Navigation Intervention (Other)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Text Message-Based Navigation Intervention (Other)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Cigarette (Drug)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Smokeless Tobacco (Drug)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Nicotine Oral Pouch (Drug)
PHASE I ARM V (Usual brand ST or cigarette)
Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
干预措施: Smokeless Tobacco (Drug)
PHASE I ARM IV (high FBN > 99% ONP)
Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Nicotine Oral Pouch (Drug)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Nicotine Oral Pouch (Drug)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Smokeless Tobacco (Drug)
PHASE I ARM II (low FBN > 99% S ONP)
Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Nicotine Oral Pouch (Drug)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Nicotine Oral Pouch (Drug)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Nicotine Oral Pouch (Drug)
PHASE I ARM II (low FBN > 99% S ONP)
Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Smokeless Tobacco (Drug)
PHASE I ARM I (low FBN R/S ONP)
Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Nicotine Oral Pouch (Drug)
PHASE I ARM III (high FBN R/S ONP)
Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Smokeless Tobacco (Drug)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Smokeless Tobacco (Drug)
PHASE I ARM III (high FBN R/S ONP)
Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Cigarette (Drug)
PHASE I ARM IV (high FBN > 99% ONP)
Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Survey Administration (Other)
PHASE I ARM IV (high FBN > 99% ONP)
Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Smokeless Tobacco (Drug)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Cigarette (Drug)
PHASE I ARM I (low FBN R/S ONP)
Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Smokeless Tobacco (Drug)
PHASE II ARM II (low FBN > 99% S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Survey Administration (Other)
PHASE II ARM III (high R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Cigarette (Drug)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Biospecimen Collection (Procedure)
PHASE I ARM II (low FBN > 99% S ONP)
Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Biospecimen Collection (Procedure)
PHASE I ARM I (low FBN R/S ONP)
Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.
干预措施: Biospecimen Collection (Procedure)
PHASE I ARM V (Usual brand ST or cigarette)
Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
干预措施: Survey Administration (Other)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Survey Administration (Other)
PHASE II ARM I (low FBN R/S ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Biospecimen Collection (Procedure)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Survey Administration (Other)
PHASE II ARM IV (high FBN > 99% ONP)
WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week.
CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use.
Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
干预措施: Text Message-Based Navigation Intervention (Other)
结局指标
主要结局
Increased nicotine delivery
时间窗: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of oral nicotine pouches (ONPs) relative to cigarettes and smokeless tobacco (ST). Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Liking
时间窗: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Craving/withdrawal suppression
时间窗: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Rate of switching to ONP
时间窗: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Rate of switching to ONPs
时间窗: Up to 3 months
Data will be used to evaluate the effects of nicotine concentration, form and isomer on switching from cigarettes or ST to ONPs either partially or completely. Logistic regression models will be used to examine whether differences in form and isomer significantly impact switching.
次要结局
- ONP and Tobacco Purchase Task(Up to 3 months)
研究者
Brittney Keller-Hamilton
Principal Investigator
Ohio State University Comprehensive Cancer Center