Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

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.

III. To characterize the effects of dual use of VLNCC and JUUL ECIGs on abuse liability.

OUTLINE:

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 are randomized to 1 of 2 arms.

ARM I: Patients smoke ECIG-high (Hi) for 3 weeks and then ECIG-low (Lo) for 3 weeks

ARM II: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.

After completion of study, patients are followed up for 30 days.

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)