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..
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
213
Smoke usual brand of cigarettes
Received NRT (Electronic Cigarette - ECIG-Hi)
Received NRT (Electronic Cigarette - ECIG-Hi)
M D Anderson Cancer Center
Houston, Texas, United States
Usual Brand Cigarettes Per Day
Mean usual brand cigarettes per day (CPD) smoked during the phase
Time frame: One to three weeks
Very Low Nicotine Content Cigarettes Per Day
Mean very low nicotine content cigarettes per day (CPD) smoked during the phase
Time frame: One to three weeks
Total Nicotine Equivalents (TNE)
Geometric means of the natural log of total nicotine equivalents (TNE), calculated as the sum of total nicotine, total cotinine, total 3'-hydroxycotinine and nicotine N-oxide excreted in urine
Time frame: One to three weeks
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Ancillary studies
Ancillary studies
Smoke very low nicotine content cigarette
Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks