Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-Cigarettes Among Daily and Non-Daily Smokers

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 213 人开始时间: 2017年10月26日最近更新: 2025年12月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: M.D. Anderson Cancer Center
入组人数: 213
试验地点: 1
主要终点: Usual Brand Cigarettes Per Day

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior in current daily and intermittent smokers..

详细描述

PRIMARY OBJECTIVES:

I. To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.

EXPLORATORY OBJECTIVES:

I. To explore the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability using biochemical measures of product use, compensation, and toxicant exposure, and self-reported measures of withdrawal, craving, affect, and satisfaction.

II. To explore the effects of switching from usual-brand cigarettes to VLNCCs, and from VLNCCs to VLNCC+ECIGs on measures of abuse liability.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Sign consent and agree to all study procedures
•Have an address where he/she can receive mail
•Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access, etc.)
•Able to follow verbal and written instructions in English
•Willing and able to complete two spirometry sessions (this criterion waived during COVID-19 pandemic)
•Be the only participant in their household
•Interested in trying novel nicotine products
•Daily smokers: >= 1 cigarette/little cigar per day
•Intermittent smokers: >= 1 cigarette/little cigar per day 4 to 27 days per month
•Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit
•The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle

排除标准

•Unwilling to refrain from other e-cigarette use for the duration of the study, other than what is provided to them for study purposes
•Current/recent use of certain medications:
•Smoking cessation meds (past 90 days; e.g., wellbutrin, bupropion, Zyban, nicotine replacement therapy [NRT], Chantix)
•Certain medications to treat depression (last 14 days; e.g., amitriptyline)
•A case by case determination will be made by study physician for medication on the precautionary list, (e.g. nitroglycerin)
•Self-reported daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (e.g., 3 to 7 days per week or less or if more frequent, use less than a month's duration
•Unstable medical condition as determined by the medical team
•Self-reported bronchial or respiratory infection in the last 14 days (this criterion waived during COVID-19 pandemic)
•Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading is < 50 (severe to very severe obstruction) (this criterion waived during COVID-19 pandemic)
•Self-reported abnormal heart rhythms or cardiovascular disease (stroke, chest pain, heart attack) in the last 3 months
•Meet criteria for major depressive syndrome or suicidality on the Patient Health Questionnaire-9 (PHQ-9)
•Self report of past or current diagnosis of bi-polar disorder or schizophrenia/schizoaffective disorder
•Self-reported other tobacco use besides cigarettes or little cigars (e.g., hookah, cigarillos, smokeless tobacco, chewing tobacco, pipes, cigars, etc.) on 10 or more days in the last month
•Recent (past 90 days), current, or planned (within the next 45 days) involvement in smoking cessation activities
•Positive urine pregnancy test at screening. Women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
•Women that are breastfeeding or of childbearing potential and not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include:
•Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)
•Barrier methods (such as condom or diaphragm) used with a spermicide, or
•An intrauterine device (IUD)
•Contraceptives sold for emergency use after unprotected sex are not acceptable methods for routine use
•Subject considered by the investigator to be unsuitable to participate in the study (e.g., due to cognitive deficits or instability to last the entire duration of the study)