A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Smoking Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers
研究概览
详细说明
This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) over a 13-week study period.
Potential participants will be recruited and enrolled at multiple sites across the U.S. They will complete a pre-screening questionnaire to assess their study eligibility approximately 60 days prior to enrollment. Participants who meet pre-screening criteria will provide an informed consent to attend a screening and enrollment visit (SEV), which is a mandatory site visit (MSV) during which participants will be screened, and eligible participants will be randomized to one of the three study arms.
Participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their Study Arm.
All participants will attend MSV on Days 0, 30, 60, and 90 with the option of changing to a different flavor among the available flavors based upon their assigned Study Arm, if applicable. In the first 4-weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits (OSV) on Days 7, 14, and 21, with the option of changing flavors to a different flavor among the available flavors in their assigned Study Arm. During the 13-week study period, participants will be free to use the ENDS and any other tobacco or nicotine products as desired. The ENDS Version 2 Power Unit technology will measure their puffing topography during use (puff duration and inter-puff interval). Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on their own smart phones. Surveys will collect data on the number of CC smoked the previous day, current flavor use, product liking, number of cigarette quit attempts, and any other tobacco or nicotine products used, intent to substitute their UB CC for the Study IP and social/environmental factors influencing switching intent. At the conclusion of the study period, all participants will return to the sites for a close out period and will be discharged from the study. Safety and adverse events/experiences (AEs) will be monitored throughout the study via a safety Hotline.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Montgomery E. Hedgecock
- 电话号码：336-741-3761
- 邮箱：montgomery_hedgecock@rjrt.com
学习地点
-
-
Florida
-
Maitland、Florida、美国、32751
- 招聘中
- Sago Orlando
-
-
Georgia
-
Atlanta、Georgia、美国、30328
- 招聘中
- Sago Atlanta
-
-
Missouri
-
St Louis、Missouri、美国、63131
- 招聘中
- Sago St. Louis
-
-
North Carolina
-
Raleigh、North Carolina、美国、27612
- 招聘中
- L&E Raleigh
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19103
- 招聘中
- Sago Philadelphia
-
-
Texas
-
Dallas、Texas、美国、75254
- 招聘中
- Sago Dallas
-
Houston、Texas、美国、77027
- 招聘中
- Sago Houston
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.
- All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
- Currently smoke at least 5 CC on smoking days in the past 30 days.
- Smoke CC on 15 or more of the past 30 days.
- Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
- Indicate a willingness to use ENDS.
- Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.
- Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.
Exclusion Criteria:
- Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
- Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Female participants who self-report not using adequate methods to prevent pregnancy.
- Persons with pacemakers or other embedded electronic medical devices fitted.
- Participants who self-report having an unstable heart condition, severe hypertension or diabetes.
- Persons who self-report they are allergic/sensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.
- Participants who self-report poor physical or mental health.
- Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible products and other oral nicotine products (tablets, gums and lozenges) on 5 or more days in the past 30 days.
- Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
- Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
- Employee of a company that manufactures tobacco or ENDS products.
- Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
- Have taken part in a tobacco/nicotine research study in the past 30 days.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：烟草风味
参与者可以在一个尼古丁水平（5％）上使用烟草风味变体。
|
Tobacco Flavor
|
|
有源比较器：Tobacco and two flavors of non-tobacco/non-menthol/mint
Participants can choose between tobacco and two non-tobacco/non-menthol/mint flavor variants at one nicotine level (5%).
|
Tobacco Flavor
Non-tobacco, Non-menthol/Mint Flavor
Non-tobacco, Non-menthol/Mint Flavor
|
|
有源比较器：Tobacco, Mint, and Menthol Flavor
Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%).
|
Tobacco Flavor
Menthol Flavor
Mint Flavor
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
大体时间：13 Weeks
|
The estimate of the risk ratio for self-reporting past 7-day abstinence from CC smoking during the final 7 days of the 13-week study period in (i) Study Arm 1 (tobacco and two NTNM flavors) versus Study Arm 3 (tobacco flavor only); and (ii) Study Arm 2 (tobacco, menthol, and mint flavors) versus Study Arm 3.
|
13 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3.
大体时间：13 weeks
|
The estimate of the proportion of participants who completely switched from CC smoking to Vuse ENDS during the entire final 7 days of the 13-week study period in Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3. Complete switching is defined as being abstinent from smoking CCs during the final 7-days of the study period, as well as being an adopter of Study IP (defined as ≥ 4 days of Study IP use [verified by puff topography data] for each week during the final two weeks of the study period).
|
13 weeks
|
|
Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).
大体时间：13 weeks
|
13 weeks
|
|
|
Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)
大体时间：13 weeks
|
"Preferred Flavor" to be defined in the statistical analysis plan (SAP), and each participant's preferred flavor will be used to assign them to their "preferred flavor group", which will be incorporated in subsequent analyses
|
13 weeks
|
|
Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3.
大体时间：13 weeks
|
13 weeks
|
|
|
Time to first 7-day abstinence by Study Arm and preferred flavor group
大体时间：13 weeks
|
13 weeks
|
|
|
Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group.
大体时间：13 weeks
|
13 weeks
|
|
|
Safety profile of the study IP
大体时间：13 weeks
|
An additional endpoint of critical importance is AEs per participant, which will be described in the tables, figures, and listings (TFLs) in addition to the final study report.
No inferential testing is planned for AEs.
|
13 weeks
|
合作者和调查者
调查人员
- 研究主任：Melissa Tapia, Ph.D.、RAIS Company
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.