Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Smoking abstinence - CO
研究概览
简要总结
To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult smoker of combustible cigarettes.
- •Age 22 to 65 years at time of screening (verified by government issued ID).
- •Smoke cigarettes for ≥12 months prior to screening.
- •Currently smokes at least 10 tobacco cigarettes per day.
- •Screening eCO ≥ 10 ppm.
- •Voluntarily provides consent for participation by signing the informed consent form (ICF).
- •Willing and able to comply with study requirements.
排除标准
- •Unable to read, speak or understand English
- •Has a history or presence of clinically significant medical or psychiatric disease, or any other condition that would in the PI's judgement jeopardize the safety of the participant, impair the participant's ability to comply with study procedures, or impact the validity of the study results.
- •Has used nicotine-containing e-cigarettes (or vapes) or any nicotine replacement therapy (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotine lozenge) or prescription smoking cessation medications, including, but not limited to, varenicline (Chantix*) or bupropion (Zyban®) within the past 30 days.
- •If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.
- •Has participated in a research study about tobacco products or ENDS within the past 30 days.
- •Has participated in a smoking cessation or nicotine switching research study in the past year.
- •Smokes or vapes cannabis more than once a week.
- •Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater.
- •Heterosexually active participants of Childbearing Potential (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of birth control (or remain abstinent) during the course of the trial. Medically acceptable methods of birth control include: vasectomy, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.
- •Subgroup enrollment is complete.
研究组 & 干预措施
Nicotine Non-Responders
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
干预措施: Nicoderm (Drug)
Nicotine Non-Responders
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
干预措施: Nicorette 4Mg Chewing Gum (Drug)
Nicotine Non-Responders
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
干预措施: Nicorette Lozenge Product (Drug)
Nicotine Non-Responders
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
干预措施: NJOY e-cigarette (Other)
Nicotine Non-Responders
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
干预措施: on! (Other)
Nicotine Responders - Group 1
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).
干预措施: Nicoderm (Drug)
Nicotine Responders - Group 1
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).
干预措施: Nicorette 4Mg Chewing Gum (Drug)
Nicotine Responders - Group 1
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).
干预措施: Nicorette Lozenge Product (Drug)
Nicotine Responders - Group 1
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).
干预措施: NJOY e-cigarette (Other)
Nicotine Responders - Group 1
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).
干预措施: on! (Other)
Nicotine Responders - Group 2
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
干预措施: Nicoderm (Drug)
Nicotine Responders - Group 2
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
干预措施: Nicorette 4Mg Chewing Gum (Drug)
Nicotine Responders - Group 2
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
干预措施: Nicorette Lozenge Product (Drug)
Nicotine Responders - Group 2
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
干预措施: NJOY e-cigarette (Other)
Nicotine Responders - Group 2
Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
干预措施: on! (Other)
结局指标
主要结局
Smoking abstinence - CO
时间窗: Week 12 and Week 24
To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks.
次要结局
- Reduction in Expired Air CO(Week 12 and Week 24)
- Usage of Nicotine Products(Week 1 through Week 24, Week 36)
- Smoking abstinence - Self report of no smoking(Week 12 and Week 24)
- Saliva Cotinine Concentrations(Week 12, Week 24, Week 36)