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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,280
- 试验地点
- 7
研究概览
简要总结
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.