Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
Cigarette Smoking-Related Carcinoma, Tobacco-Related Carcinoma
About this trial
This is an interventional prevention trial for Cigarette Smoking-Related Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.