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

Cigarette Smoking-Related Carcinoma Clinical Trial

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

Clinical Trial Summary

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..

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02964182
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date October 26, 2017
Completion date June 30, 2025
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