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Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers with a Mental Health Condition

Principal Investigator(s): Jonathan Foulds

Funding Mechanism: NIH Grant

ID number: 1R01DA048428-01

Award Date: July 30, 2019

Institution: Pennsylvania State University


Individuals with mental health conditions are particularly vulnerable to tobacco use. The goal of this project is to determine the likely health effects of use of very low nicotine content (VLNC) cigarettes, in conjunction with availability of nicotine-containing e-cigarettes, in adult smokers (aged 18-65) with mental health conditions. Study aims are: (1) to determine whether smokers with mental health conditions have lower levels of markers of harm (e.g. urine NNAL, carbon monoxide [CO]), measures of mental health, and cigarette addiction when switched to VLNC cigarettes for 16 weeks, as compared with normal nicotine content cigarettes (NNCs); (2) to determine whether smokers with mental health conditions have lower levels of markers of harm and cigarette addiction when provided with nicotine-containing (15mg/ml) versus zero nicotine e-cigarettes in order to switch to e-cigarettes or lower their cigarette consumption; and (3) to determine whether use of VLNCs increases the proportion of smokers who completely switch away from combustible tobacco use, as assessed four weeks after the end of the randomized phase of the trial. Researchers will randomize 240 smokers with mental health conditions to one of four groups: (1) NNCs (11mg nicotine/cigarette) and 15 mg/mL nicotine e-cigarettes; (2) NNCs and zero mg/mL nicotine e-cigarettes; (3) VLNCs (0.2 mg nicotine/cigarette) and 15mg/mL nicotine e-cigarettes; and (4) VLNCs and zero mg/mL nicotine e-cigarettes. Subjects will be followed for 16 weeks on study products and then another four weeks thereafter. At the end of the 16-week phase, participants will attend their last visit, receive encouragement to quit all tobacco products, and notified of community resources where they can receive smoking cessation counseling. Participants will be asked to provide information about their intentions for ongoing tobacco product use or cessation and will be followed for four weeks to assess these outcomes; those claiming to be no longer using combustible tobacco products will be visited to verify with a measure of exhaled CO. Study findings may inform regulatory activities related to VLNCs.